PART He-P 4030 LICENSING OF RADIOACTIVE MATERIAL

PART He-P 4040 REGISTRATION OF RADIATION MACHINES, MAGNETIC RESONANCE IMAGING MACHINES AND PROVIDERS OF SERVICES

He-P 4040.01 Purpose. This part provides for:

(a) The evaluation of the need for shielding for new and modified ionizing radiation facilities;

(b) The process for the registration of ionizing radiation machines;

(d) The process for the registration of persons providing radiation machine or MRI servicing, or services; and

(e) The process for the approval of an out-of-state radiation or MRI machine to be brought into the State of New Hampshire.

Source. #6827, eff 8-6-98; ss by #7919, eff 7-18-03; ss by #9945-A, eff 6-22-11; ss by #10864, eff 6-25-15

He-P 4040.02 Scope. This part shall apply to each person:

(a) In possession of an ionizing radiation or MRI machine;

(b) Who wishes to dispose of or make a change of ownership of a radiation or MRI machine;

(d) Who wishes to bring a radiation or MRI machine, from another state, into the State of New Hampshire.

Source. #6827, eff 8-6-98; ss by #7919, eff 7-18-03; ss by #9945-A, eff 6-22-11; ss by #10864, eff 6-25-15

He-P 4040.03 Shielding Plan Review.

(a) Prior to new construction or modification of existing installations utilizing ionizing radiation machines, a review of floor plans, shielding specifications, and equipment arrangements shall be completed as set forth in paragraphs (b)-(d) below to ensure that, once operational, no individual will receive a dose in excess of the limits prescribed in He-P 4020.

(b) All prospective and existing registrants shall utilize the design services of a registered service provider as described in He-P 4040.07.

(c) Each prospective or existing registrant may request the department of health and human services/radiological health section (DHHS/RHS) to provide an evaluation of an existing shielding plan review or to offer technical advice on shielding requirements for a radiation machine installation.

(d) The following information shall be submitted to DHHS/RHS with any request for a shielding plan review:

(1) Distances where applicable, such as:

a. From the source of radiation to the patient;

b. From the source of radiation to each point for which the shielding requirement is to be calculated; and

c. From the patient to each point for which the shielding requirement is to be calculated;

(2) The normal location(s) of the system's radiation port;

(3) The travel and traverse limits of the radiation beam port(s);

(4) Direction(s) in which the useful beam will be directed;

(5) Locations of any windows, doors or other openings;

(6) The location of the operator's booth;

(7) The location of the control panel;

(8) The structural composition and thickness or lead equivalent of all existing or planned walls, doors, partitions, floor, and ceiling of the room(s) to be evaluated;

(9) The dimensions of the room(s) to be evaluated;

(10) The type of occupancy of all adjacent areas, including the space above and below the rooms(s), and, if there is an exterior wall, the distance to the closest area(s) where it is likely that an individual might be present;

(11) The make and model of the equipment, the maximum technique factors as defined in He-P 4041, and the output waveform;

(12) The type of examination(s) or treatment(s) to be performed with the equipment; and

(13) Information on the anticipated workload of the system(s) in milliampere seconds (mAs) per week, milliampere seconds being the product of the x-ray tube current and the exposure time.

(e) After installation of a radiation machine, the registrant shall keep the following records for review during an inspection by DHHS/RHS until the registration is terminated:

(1) The maximum rated technique factors, as defined in He-P 4041, of each machine;

(2) A scaled drawing of the room in which each stationary radiation machine system is located indicating the location of tubeheads, describing the use of each area adjacent to the room, and specifying an estimation of the extent of occupancy by an individual in such areas;

(3) The results of a survey for radiation levels present at the operator's position and at pertinent points outside the room at specified test conditions; and

(4) The shielding plan review which shall include the type and thickness of materials, or lead equivalency, of each protective barrier.

(f) After installation of an MRI machine and until the registration is terminated, the registrant shall keep the following records for review during an inspection by DHHS/RHS:

(1) A scaled drawing of the MRI suite indicating the location of reception, patient, prescreening, control room, MRI machine, fire extinguishers and equipment;

(2) An MRI suite safety protocol which shall be reviewed:

a. Annually; and

b. After any change is made to the MRI suite; and

(3) Documentation that the local fire department is aware of the presence of MRI suite hazards in the event of an emergency response.

Source. #6827, eff 8-6-98; ss by #7919, eff 7-18-03; ss by #9945-A, eff 6-22-11; ss by #10864, eff 6-25-15

He-P 4040.04 Registration of Radiation or MRI Machines.

(a) Each person having possession of any ionizing radiation or MRI machine, except those specifically exempted in He-P 4040.06, or those applying for reciprocal recognition of an out-of-state radiation or MRI machine in accordance with 4040.11, shall register such machine with DHHS/RHS within 30 days after its acquisition.

(b) Each person leasing or renting a radiation or MRI machine as defined in He-P 4041 shall be subject to the machine registration requirements of He-P 4040.04.

(c) Application for registration of a radiation or MRI machine shall be made on FORM DHHS/RHS A “Application for Radiation or Magnetic Resonance Imaging Machine Registration” (May, 2015) provided by DHHS/RHS.

(d) The registration period shall begin on August 1 and end on July 31^st of the following year.

(e) All registrations shall be renewable as described in He-P 4040.09.

(f) No person having possession of a radiation or MRI machine shall operate such machine or cause it to be operated until it is registered with DHHS/RHS pursuant to He-P 4040.04.

(g) DHHS/RHS shall issue a certificate of registration provided that the requirements of He-P 4040.04 and the applicable fee payment required under He-P 4070.06 have been met.

(h) The registrant shall retain the certificate of registration until it expires as per He-P 4040.08.

(i) The registrant shall notify DHHS/RHS in writing within 15 days of any change in the information submitted in the application for registration and contained on the certificate of registration.

(j) The disposal or change of ownership of any registered machine shall be made in accordance with He-P 4040.05.

(k) Each registrant shall be responsible for radiation protection in operations with each radiation machine.

(l) Each registrant shall prohibit any person from furnishing radiation or MRI machine servicing or services as described in He-P 4040.07 to a radiation or MRI machine or facility until such person provides a current certificate of registration as evidence that they are registered with DHHS/RHS as a provider of services.

(m) No person shall assemble, install or use radiation or MRI machines unless such machines, when properly placed in operation, meet the requirements of this chapter.

(n) Machines purchased during the month of July shall be registered according to He-P 4040.04(a), and shall be assessed the applicable fee set forth in He-P 4070 during the month of August.

(o) In addition to the requirements set forth in He-P 4040:

(1) All radiation and MRI machine registrants shall follow the requirements set forth in He-P 4001 through He-P 4003, He-P 4019 through He-P 4022, He-P 4041 and He-P 4045;

(2) Registrants utilizing analytical x-ray and radiation generating devices shall be subject to the requirements of He-P 4043;

(3) Registrants utilizing particle accelerators shall be subject to the requirements of He-P 4044;

(4) Registrants utilizing radiation or MRI machines for all diagnostic purposes, including veterinarians shall be subject to the requirements of He-P 4045 and He-P 4046;

(5) Registrants utilizing therapeutic radiation machines shall be subject to the requirements of He-P 4047; and

(6) Registrants engaged in industrial radiographic operations shall be subject to the requirements of He-P 4034.

Source. #6827, eff 8-6-98; ss by #7919, eff 7-18-03; amd by #9945-A, eff 6-22-11, (paras (a), (c), & (d)-(j)); amd by #9945-B, eff 6-22-11, (para (b)); ss by #10864, eff 6-25-15

He-P 4040.05 Disposal of or Change of Ownership of a Radiation or MRI Machine.

(a) A machine registration shall be non-transferable.

(b) A registrant shall submit a completed FORM DHHS/RHS D “Certificate - Disposition or Change of Ownership of Radiation or MRI Machine” (May, 2015) provided by DHHS/RHS when modifying the possession of a registered machine as follows:

(1) Upon disposal of a registered machine either by donation or disposal;

(2) Upon change of ownership of a business entity with a registered machine(s);

(3) Upon replacement of a registered machine by a registered service provider;

(4) Upon disposal of an originally registered machine unable to be repaired or calibrated; or

(5) Upon the sale of a registered machine.

Source. #10864, eff 6-25-15

He-P 4040.06 Exemptions.

(a) Any electronic equipment that produces ionizing radiation incidental to its operation shall be exempt from the requirements of this part provided that the dose equivalent rate averaged over an area of 10 square centimeters does not exceed 5 μSv (0.5 millirem) per hour at 5 centimeters from any accessible surface of such equipment.

(b) Any radiation or MRI machine while in transit or in storage incident thereto shall be exempt from the registration requirements of this part.

(d) Permanently inoperable radiation or MRI machines shall be exempt from the requirements of this part.

(e) Loaner machines, as defined in He-P 4041, shall be exempt from the requirements of this part as long as the loan does not exceed the 30 days. If the loaner machine remains in the state after 30 days, the registrant shall comply with He-P 4040.04, He-P 4040.05, and He-P 4070. The registrant shall submit written notification to DHHS/RHS regardless of the duration of use of the loaner machine. Notification shall include registrant name, and the machine make, model, serial number and acquisition date.

(f) Financial institutions that take possession of a radiation or MRI machine as a result of foreclosure, bankruptcy, or other default of payment shall be exempt from the requirements in this part to the extent that they demonstrate that the unit is only operable for the sole purpose of selling or leasing the unit.

(g) An individual employed by a registrant to perform, on an in-house basis only, calibrations, equipment performance evaluations, or minor repairs of that registrant’s diagnostic or industrial radiation or MRI machines, shall be exempt from the service provider registration requirements of this part, unless the individual also provides these services to other registrants.

(h) The following shall not be exempt:

(1) Electron beam welders;

(2) Electron microscopes;

(3) Providers of radiation or MRI machines for mobile services; and

(4) Providers of service for electronic equipment in (a) above during testing or servicing.

(i) When the registrant of the portable radiation machine, used solely for security-related, non-human imaging applications, is a state agency or local government, the registrant shall be exempt from the payment of the registration fee as required under He-P 4070.06. The registrant shall ensure that possession and use of the radiation machine comply with all applicable requirements of He-P 4000, New Hampshire Rules for the Control of Radiation.

Source. #6827, eff 8-6-98; ss by #7919, eff 7-18-03; ss by #9945-A, eff 6-22-11; ss by #10864, eff 6-25-15 (from He-P 4040.05); amd by#13280, eff 10-21-21

He-P 4040.07 Application for Registration of Servicing and Services.

(a) Each person who is engaged in the business of installing radiation or MRI machines, or is engaged in the business of furnishing or offering to furnish radiation or MRI machine servicing or services as described in He-P 4040.07(b) shall apply for registration with DHHS/RHS prior to furnishing or offering to furnish such services.

(b) Application for registration of persons providing servicing or services shall be made on FORM DHHS/RHS SP “Application for Registration as a Provider of Radiation or MRI Machine-Related Services” (May, 2015) provided by DHHS/RHS.

(1) Therapy unit services as follows:

a. Radiation therapy physicist as required by He-P 4047.04(k); or

b. Calibration and compliance surveys of radiation therapy units;

(2) Installation and servicing of radiation or MRI machines, therapeutic radiation machines or radiation machines for other use and associated radiation or MRI machine components;

(3) Radiation protection consultation or surveys;

(4) Design of shielding or access controls for diagnostic, therapeutic or other facilities;

(5) Calibration of radiation or MRI machines, measurement instruments, or radiation devices;

(6) Personnel dosimetry services; or

(7) Distribution or sales of radiation or MRI machines.

(d) Each person applying for registration under He-P 4040.07 shall also provide the following:

(1) A description of the minimum education, training, and experience that the applicant will require of each individual who will provide services under this registration, as follows:

a. For installers, relative to radiation safety and any applicable federal or state regulations pertaining to the manufacture, assembly, installation, acceptance and quality control testing, and functioning of radiation or MRI machines; and

b. For radiation protection consultants and designers of shielding and access controls, relative to radiation safety and protection, including radiation surveys and measurement, instrumentation, shielding, and radiation protection engineering; and

c. For qualified experts, the individual shall:

1. Be certified in the appropriate field by the American Board of Radiology, the American Board of Health Physics, the American Board of Medical Physics or the American Board of Nuclear Medicine Science; or

2. Hold a master’s or doctoral degree in physics, biophysics, radiological physics, health physics, or medical physics and have completed one year of documented, full time training in the appropriate field and also one year of documented, full time work experience under the supervision of a qualified expert in the appropriate field. To meet this requirement, the individual shall have performed the tasks required of a qualified expert during the year of work experience; or

3. Receive approval from DHHS/RHS for specific activities if he or she has:

a. A bachelor’s degree in physics, biophysics, radiological physics, health physics, or medical physics; and

b Completed 6 years of documented full time training and work experience in the appropriate field;

(2) A complete list of all individuals who will be providing services in New Hampshire under this registration;

(3) A description of the measuring instruments to be used for the type of service to be provided and the frequency of calibration of those instruments; and

(4) An attestation, signed and dated by the applicant, or management representative stating: “I certify that the applicant (1) understands and shall follow the relevant requirements of the New Hampshire Rules for the Control of Radiation (He-P 4000) applicable to the types of servicing or services to be provided under this registration and (2) shall adhere and require adherence to them and good radiation safety practices.”

(e) No registered service provider shall perform services that are not specifically stated on the certificate of registration issued by DHHS/RHS.

(f) DHHS/RHS shall issue a certificate of registration provided that the requirements of He-P 4040.07 and the fee required by He-P 4070.06 have been met.

(g) The registered service provider shall retain the certificate of registration until it expires.

(h) Registration is renewable as described in He-P 4040.09.

Source. #6827, eff 8-6-98; ss by #7919, eff 7-18-03; amd by #9945-A, eff 6-22-11, (paras (a) & (c)-(e)); amd by #9945-B, eff 6-22-11, (para (b)); ss by #10864, eff 6-25-15

He-P 4040.08 Expiration of Certificates of Registration.

(a) Each certificate of registration for possession of a radiation or MRI machine shall expire at the end of the day on the first July 31 after issuance of the certificate.

(b) Each certificate of registration for servicing and services shall expire at the end of the day on the first July 31 after issuance of the certificate.

(c) The registration for any individual machine shall terminate upon disposal, permanent removal or change of ownership, of the machine as described in He-P 4040.05.

Source. #6827, eff 8-6-98; ss by #7919, eff 7-18-03; ss by #9945-A, eff 6-22-11; ss by #10864, eff 6-25-15 (from He-P 4040.07)

He-P 4040.09 Renewal of Certificates of Registration.

(a) Renewal of a certificate of registration for possession of a radiation or MRI machine shall be made in writing prior to August 1^st of each year.

(b) The machine renewal application shall include the following:

(1) Updated or changed information about the radiation or MRI machine status since issuance of the most recent certificate of registration, including any of the following:

a. Type of machine;

b. Location of machine;

c. Transfer of ownership

d. Transfer to alternate site;

e. Change in status from in use to storage;

f. Change in status from storage to in use; or

g. Addition of any radiation or MRI machine;

(2) A completed FORM DHHS/RHS A “Application for Radiation or Magnetic Resonance Imaging Machine Registration” (May, 2015) as required in He-P 4040.04 if any changes have been made;

(3) A completed FORM DHHS/RHS D “Certificate-Disposition or Change of Ownership of Radiation or MRI Machine” (May, 2015) as required in He-P 4040.05, if applicable;

(4) A check made payable to “Treasurer- State of New Hampshire” for the appropriate fee listed in He-P 4070.06; and

(5) An attestation signed and dated by the registrant, or a certifying officer signing on behalf of the registrant, attesting to the following: “I, the registrant or certifying officer signing on behalf of the registrant, understand and shall follow the relevant requirements of the New Hampshire Rules for the Control of Radiation (He-P 4000) and confirm that all of the information herein is complete and accurate.”

(c) Each prospective or renewing registrant who fails to submit the registration fee within 30 days of the date that the application and fee are due, shall be assessed an administrative fine of $100 with the fee as described in He-P 4070.08.

(d) Renewal of registration as service providers pursuant to He-P 4040.07 shall be made in writing prior to August 1^st of each year.

(e) The service provider application for a renewal of registration shall include the following:

(1) A signed and dated renewal of a certificate of registration for servicing and services shall be made on FORM DHHS/RHS-RSP “Annual Renewal of Radiation or MRI Machine-Related Service Provider Registration” (May, 2015) provided by DHHS/RHS;

(2) An attestation signed and dated by the applicant, or management representative stating “I certify that the applicant (1) understands and shall follow the relevant requirements of the New Hampshire Rules for the Control of Radiation (He-P 4000) applicable to the types of services or servicing to be provided under this registration and (2) shall adhere and require adherence to them and good radiation safety practices.”; and

(3) A check made payable to “Treasurer- State of New Hampshire” for the appropriate fee listed in He-P 4070.06.

Source. #6827, eff 8-6-98; ss by #7919, eff 7-18-03; ss by #9945-A, eff 6-22-11; ss by #10864, eff 6-25-15; ss by #10864, eff 6-25-15

He-P 4040.10 Assembler and/or Transferor Obligation.

(a) Any person who sells, leases, transfers, lends, disposes, assembles, or installs radiation or MRI machines shall register as a service provider and notify DHHS/RHS within 15 days of:

(1) The name and address of persons who have received these machines;

(2) The manufacturer, model, and serial number of each radiation or MRI machine transferred; and

(3) The date of transfer of each machine, if applicable.

(b) No person shall make, sell, lease, transfer, lend, assemble, or install radiation or MRI machines or the supplies used in connection with such machines unless such supplies and equipment, when properly placed in operation, meet the requirements of this chapter.

Source. #6827, eff 8-6-98; ss by #7919, eff 7-18-03; ss by #9945-A, eff 6-22-11; ss by #10864, eff 6-25-15 (from He-P 4040.09)

He-P 4040.11 Reciprocal Recognition of Out-of-State Radiation and MRI Machines.

(a) A person proposing to bring any radiation or MRI machine into New Hampshire from another state, for any use, shall apply to DHHS/RHS in writing at least 3 business days prior to use of the machine in the state.

(b) Any radiation or MRI machine used for demonstration purposes shall follow He-P 4040.11.

(c) Application for recognition of a person proposing to bring an out-of-state machine into New Hampshire shall be made on FORM DHHS/RHS-RP “Registration for Reciprocal Recognition of Out-of-State Machines” (May, 2015) provided by DHHS/RHS.

(d) The applicant shall provide, with the application, a fee equal to half the annual fee set out in He-P 4070.06, for each radiation or MRI machine the applicant proposes to bring into the state with the first application for that radiation or MRI machine in the calendar year.

(e) The reciprocity fee required by (d) above shall cover a period of one year from the time of application, at which time a new fee submittal shall be required.

(f) In the event an applicant proposes subsequently to bring into the state in the same calendar year a machine with a higher annual fee, the applicant shall provide with the application a fee equal to half the difference between the fees of the 2 types of machines.

(g) DHHS/RHS shall not grant approval to any application for an out-of-state radiation or MRI machine requiring a fee, if the fee does not accompany the application.

(h) DHHS/RHS shall refund the fee accompanying any application requiring one if it does not grant approval for that application.

(i) The applicant shall apply in writing for a waiver to use an out-of-state radiation or MRI machine with less than 3-business days prior written notification.

(j) DHHS/RHS shall grant a waiver of the 3-business day application limit on determining that adherence to the limit would endanger an individual’s or the public’s health and safety.

(k) The person entering the state under reciprocity shall:

(1) Comply with the rules in this chapter as they relate to radiation or MRI machines, their operators, and operations of the machines;

(2) Supply additional information as requested by DHHS/RHS for the purposes of protecting public and worker health and safety and ensuring the safe use of machines within the state; and

(3) Not operate an out-of-state machine within the state under reciprocity in excess of 180 calendar days per year.

(l) Any radiation or MRI machine shall be subject to unannounced inspection by DHHS/RHS during the duration of the out-of-state recognition of reciprocal registration.

Source. #6827, eff 8-6-98; ss by #7919, eff 7-18-03; ss by #9945-A, eff 6-22-11; ss by #10864, eff 6-25-15 (from He-P 4040.10)

He-P 4040.12 Radiation or MRI Machines in Storage.

(a) A radiation or MRI machine shall be categorized as a machine in storage if it meets the following conditions:

(1) The machine is registered with DHHS/RHS in accordance with the requirements of He-P 4040.04;

(2) The machine is physically disconnected from any source of operating electric power in one or more of the following ways:

a. By the removal of its power cord or plug, if so equipped;

b. By the removal of its direct connection from the facility's electrical wiring system, if so connected;

c. By the removal of its internal main fuse or circuit breaker, if so equipped; or

d. By having its external circuit breaker or electrical circuit disconnect locked in an electrically non-conducting condition with a key-operated or combination lock; and

(3) The machine has at its operating control or console a tag or label bearing the words "In storage.”

(b) The placement of a machine into the storage status shall be recorded on FORM DHHS/RHS D “Certificate-Disposition or Change of Ownership of Radiation or MRI Machine” (May, 2015) which shall be submitted to DHHS/RHS. Upon approval by DHHS/RHS, the status of the registered machine shall be changed to “in storage” while it remains out of service.

(c) A registrant shall not put into service or restore to service a machine registered as in storage until a completed FORM DHHS/RHS D “Certificate-Disposition or Change of Ownership of Radiation or MRI Machine” (May, 2015) has been submitted and the difference between the fee for the machines in storage and the fee that would otherwise apply for such machine, as set out in He-P 4070.06, has been paid.

(d) DHHS/RHS shall not require machines in storage under the provisions of this section to meet the requirements in Parts He-P 4041 through He-P 4047, for that machine type.

(e) A registered machine approved of as in storage shall qualify for the fee specified in He-P 4070.06 for a machine in storage.

Source. #6827, eff 8-6-98; ss by #7919, eff 7-18-03; ss by #9945-A, eff 6-22-11; ss by #10864, eff 6-25-15 (from He-P 4040.11)

He-P 4040.13 Waivers.

(a) DHHS/RHS has found that He-P 4040 applies to a variety of conditions and uses, and that the strict application of these rules may result in hardship or misapplication. The purpose of these waiver procedures is to accommodate those situations where strict adherence would not be in the best interest of the public.

(b) Any person who is or would be directly and adversely affected by the strict application of a rule in He-P 4040 may request a waiver, provided that such waiver does not contravene a federal statute or regulation, state statutory requirement, or state or federal constitutional requirement.

(d) The request for a waiver shall include the following information:

(1) The identification of the facility or activity to which the request relates;

(2) The specific citation to the He-P 4040 rule from which a waiver is sought;

(3) A full explanation of why a waiver is being requested;

(4) A full explanation of any alternate procedure, method, or other activity that is sought to be substituted for the procedure, method, or other activity that is required by the rule from which a waiver is being sought;

(5) The limit of duration requested for the waiver; and

(6) A full explanation of why the person believes that having the waiver granted will not adversely impact the public health or safety, the environment, or property.

(e) All requests for a waiver shall be submitted to DHHS/RHS.

(f) Where a request for a waiver relates to an application for a registration, the person requesting the waiver shall submit the request as part of such application, or as soon thereafter as the person identifies the need for the request.

(g) DHHS/RHS shall grant a request for a waiver if the requesting party demonstrates that:

(1) The waiver shall not result in an adverse effect to public health or safety, the environment, or property; and

(2) Strict compliance with the applicable section of He-P 4040 rule:

a. Will result in an adverse effect to the public health or safety, the environment, or property; or

b. Is technologically infeasible.

(h) DHHS/RHS shall send written notification to the person requesting the waiver of the determination on the request. If the waiver is submitted as part of the registration application and is granted, it shall become part of the registration document.

Source. #10505, eff 1-11-14; ss by #10864, eff 6-25-15 (from He-P 4040.12)

PART He-P 4041 USE OF RADIATION MACHINES: DEFINITIONS

He-P 4041.01 Scope. The definitions in He-P 4041.02 shall be in addition to the definitions in He-P 4003.

Source. #6827, eff 8-6-98; ss by #8692, INTERIM, eff 7-27-06, EXPIRES: 2-2-07; ss by #8808, eff 1-24-07; ss by #10806, eff 3-28-15; ss by #14300, eff 7-1-25, EXPIRES: 7-1-35

He-P 4041.02 Definitions.

(a) “Accessible surface” means the external surface of the enclosure or housing of the radiation-producing machine as provided by the manufacturer.

(b) “Accessory component” means a component which is:

(1) Used with diagnostic x-ray systems, such as a cradle or film changer, that is not necessary for the compliance of the system with applicable provisions of He-P 4041 but which requires an initial determination of compatibility with the system; or

(2) Necessary for the compliance of the system with applicable provisions of He-P 4041, but which may be interchanged with similar compatible components without affecting the system’s compliance, such as one of a set of interchangeable beam-limiting devices; or

(3) Compatible with all x-ray systems with which it may be used and that does not require compatibility or installation instructions, such as a tabletop cassette holder.

(d) “Air kerma (K)” means the kinetic energy released in air by ionizing radiation, and is determined as the quotient of dE by dM, where dE is the sum of the initial kinetic energies of all the charged particles liberated by uncharged particles in air of mass dM, and is expressed in the SI unit of joule per kilogram, and the special name for the unit of kerma is “gray” (Gy).

(e) “Air kerma rate (AKR)” means the air kerma per unit time.

(f) “Aluminum equivalent” means the thickness of type 1100 aluminum alloy for which the nominal chemical composition is 99.00 percent minimum aluminum, 0.12 percent copper which affords the same attenuation, under specified conditions, as the material in question.

(g) “Annual” means a period of time or an event happening once a year.

(h) “Articulated joint” means a joint between 2 separate sections of a tabletop which provides the capacity of one of the sections to pivot on the line segment along which the sections join.

(i) “Assembler” means any person engaged in the business of assembling, replacing, or installing one or more components into an x-ray system or subsystem and includes the owner of an x-ray system or his or her employee or agent who assembles components into an x-ray system that is subsequently used to provide professional or commercial services.

(j) “Attenuation” means the reduction of exposure rate upon passage of radiation through matter.

(k) “Attenuation block” means a block or stack of type 1100 aluminum alloy, or aluminum alloy having equivalent attenuation, with dimensions 20 centimeters (cm) or larger by 20 cm or larger by 3.8 cm, that is large enough to intercept the entire x-ray beam.

(l) “Automatic exposure control (AEC)” means a device which automatically controls one or more technique factors in order to obtain at a pre-selected location(s) a required quantity of radiation. The term includes devices such as phototimers and ion chambers.

(m) “Automatic exposure rate control (AERC)” means a device which automatically controls one or more technique factors in order to obtain at a pre-selected location(s) a required quantity of radiation.

(n) “Backscatter” means the scattering of radiation or particles in a direction opposite to that of the incident radiation due to reflection from particles of the medium traversed.

(o) “Backscatter system” means a security screening system that makes use of radiation scattered or deflected from an object or person to form an image of the scattering object or person.

(p) “Beam axis” means a line from the source through the center of the x-ray field.

(q) “Beam-limiting device” means a device which provides a means to restrict the dimensions of the x-ray field.

(r) “Beam monitoring system” means a system designed to detect and measure the radiation present in the useful beam.

(s) “Bone densitometry system” means a medical device which uses electronically-produced ionizing radiation to determine the density of bone structures of human patients.

(t) “Calibration” means:

(1) The determination of the response or reading of an instrument relative to a series of known radiation values over the range of the instrument;

(2) The determination of the radiation dose or exposure rate at a designated distance from a radiation source under specified conditions of measurement;

(3) To check, adjust, or systematically standardize to graduations of a quantitative measuring instrument; and

(4) To check, adjust or systematically bring radiation-producing equipment into manufacturer’s specifications.

(u) “C-arm fluoroscope” means a fluoroscopic x-ray system in which the image receptor and x-ray tube housing assembly are connected or coordinated to maintain a spatial relationship. A C-arm fluoroscope system allows a change in the direction of the beam axis with respect to the patient without moving the patient.

(v) “Cantilevered tabletop” means a tabletop designed such that the unsupported portion can be extended at least 100 centimeters (cm) beyond the support.

(w) “Cassette holder” means a device, other than a spot film device, that supports and/or fixes the position of an image receptor during a radiographic exposure.

(x) “Cephalometric device” means a device intended for the radiographic visualization and measurement of the dimensions of the human head.

(y) “Certified components” mean components of x-ray systems which are subject to regulations promulgated under Public Law 90-602, the Radiation Control for Health and Safety Act of 1968.

(z) “Certified system” means any x-ray system which has one or more certified component(s).

(aa) “Changeable filters” means any filter, exclusive of inherent filtration, which can be removed from the useful beam through any electronic, mechanical, or physical process.

(ab) “Coefficient of variation” or “C” means the ratio of the standard deviation to the mean value of a population of observations. It is estimated using the following equation:

where:

s = Standard deviation of the population;

= Mean value of observations in sample;

x_i= The i^th observation sampled; and

n = Number of observations sampled.

(ac) “Computed radiography (CR)” means a projection x-ray imaging method in which a cassette houses a phosphor plate rather than photographic film. This photostimulable phosphor-coated plate captures a latent image when exposed to x-rays and, when processed, releases light that is converted to a digital image.

(ad) “Computed tomography (CT)” means the production of a tomogram by the acquisition and computer processing of x-ray transmission data.

(ae) “Computed tomography dose index (CTDI)” means the integral from -7T to +7T of the dose profile along a line perpendicular to the tomographic plane divided by the product of the nominal tomographic section thickness and the number of tomograms produced in a single scan, that is:

where:

z = Position along a line perpendicular to the tomographic plane;

D(z) = Dose at position z;

T = Nominal tomographic section thickness; and

n = Number of tomograms produced in a single scan.

This definition assumes that the dose profile is centered around z = 0 and that, for a multiple tomogram system, the scan increment between adjacent scans is nT.

(af) “Collimator” means a device, as referenced in He-P 4043-4047, for restricting the useful radiation in one or more directions.

(ag) “Cone beam computed tomography (CBCT)” means a digital volume tomography method used in some imaging applications using 2 dimensional digital detector arrays, and a cone-shaped x-ray beam, instead of a fan-shaped beam, that rotates around the patient to generate a high resolution, 3D image, with high geometric accuracy. Reconstruction algorithms can be used to generate images of any desired plane.

(ah) “Contact therapy system” means an x-ray system used for therapy with the x-ray tube port placed in contact with or within 5 centimeters of the surface being treated.

(ai) “Contrast resolution” means the ability to detect, image, and display similar tissues or materials such as gray-white matter and liver-spleen.

(aj) “Contrast scale (CS)” means the change in the linear attenuation coefficient per CTN relative to water, that is:

where:

μ_x = Linear attenuation coefficient of the material of interest;

μ_w = Linear attenuation coefficient of water;

CTN_x= CTN of the material of interest; and

CTN_w= CTN of water.

(ak) “Control panel” means that part of the x-ray control upon which are mounted the switches, knobs, pushbuttons, and other hardware necessary for manually setting the technique factors.

(al) “Cooling curve” means the graphical relationship between heat units stored and cooling time.

(am) “CT conditions of operation” means all selectable parameters governing the operation of a CT x-ray system including, but not limited to, nominal tomographic section thickness, filtration, and the technique factors as defined in He-P 4041.02(fd).

(an) “CT dosimetry phantom” means the phantom used for determination of the dose delivered by a CT x-ray system.

(ao) “CT gantry” means the tube housing assemblies, beam-limiting devices, detectors, and the supporting structures, frames, and covers which hold and/or enclose these components.

(ap) “CT number (CTN)” means the number used to represent the x-ray attenuation associated with each elemental area of the CT image.

where:

k = A constant, a normal value of 1,000 when the Hounsfield scale of CTN is used;

μ_x = Linear attenuation coefficient of the material of interest; and

μ_w = Linear attenuation coefficient of water.

(aq) “CT scan” means the complete process of collecting x-ray transmission data for the production of a tomogram. This includes data collected simultaneously during a single scan for the production of one or more tomograms.

(ar) “CT scan increment” means the amount of relative displacement of the patient with respect to the CT system between successive scans measured along the direction of the displacement.

(as) “CT scan time” means the time between the beginning and end of the x-ray transmission data accumulation for a CT scan.

(at) “Cumulative air kerma” means the total air kerma accrued from the beginning of an examination or procedure and includes all contributions from fluoroscopic and radiographic irradiation.

(au) “Dead-man switch” means a switch so constructed that a circuit closing contact can be maintained only by continuous pressure on the switch by the operator.

(av) “Demonstration” means a showing of the merits of a machine to a prospective customer.

(aw) “Diagnostic imaging system” means an assemblage of components for the generation, emission, reception, transformation, storage, and visual display of the resultant image.

(ax) “Diagnostic source assembly” means the tube housing assembly with a beam-limiting device attached.

(ay) “Diagnostic x-ray system” means an x-ray system designed for irradiation of any part of the human or animal body for the purpose of diagnosis or visualization.

(az) “Diagnostic x-ray imaging system” means an assemblage of components for the generation, emission and reception of x-rays and the transformation, storage and visual display of the resultant x-ray image.

(ba) “Digital radiography (DR)” means an x-ray imaging method or radiography which produces a digital rather than film projection image. The term includes both CR and DDR.

(bb) “Direct digital radiography (DDR”) means an x-ray imaging method in which a digital sensor, rather than photographic film or phosphor plate, is used to capture an x-ray image. DDR is a cassette-less imaging method providing faster acquisition time than cassette-based CR, using an electronic sensor that converts x-rays to electronic signals, current or charge, when exposed to x-rays.

(bc) “Direct scattered radiation” means that scattered radiation which has been deviated in direction only by materials irradiated by the useful beam.

(bd) “Dose area product (DAP)” means the product of the air kerma and the area of the irradiated field and is measured in Gy-cm², so it does not change with the distance from the x-ray tube. The term includes the term kerma-area product (KAP).

(be) “Dose profile” means the dose as a function of position along a line.

(bf) “Elemental area” means the smallest area within a tomogram for which the x-ray attenuation properties of a body are depicted.

(bg) “Elemental area” means the smallest area within a tomogram for which the x-ray attenuation properties of a body are depicted.

(bh) “Emergency procedure” means the written pre-planned steps to be taken in the event of actual or suspected exposure of an individual in excess of administrative or regulatory limits. This procedure includes the names and telephone numbers of individuals to be contacted as well as directives for processing the film badge or other personnel monitoring devices.

(bi) “Entrance skin exposure (ESE)” means x-ray exposure of the skin, expressed in mR or air kerma (Gy).

(bj) “Equipment” means “x-ray equipment” as defined in He-P 4041.02(ft).

(bk) “Exposure rate” means the amount of ionization produced or incident per unit of time.

(bl) “Field emission equipment” means equipment which uses an x-ray tube in which electron emission from the cathode is due solely to the action of an electric field.

(bm) “Filter” means material placed in the useful beam to absorb preferentially selected radiations.

(bn) “Fluoroscopic air kerma display devices” means separate devices, subsystems or components that provide the display of AKR and cumulative air kerma. They include radiation detectors, if any, electronic and computer components, associated software and data displays.

(bo) “Fluoroscopic imaging assembly” means the image receptor(s), the image intensifier, the spot-film device, electrical interlocks, and structural material providing linkage between the image receptor and diagnostic source assembly as a subsystem in which x-ray photons produce a fluoroscopic image.

(bp) “Fluoroscopic irradiation time” means the cumulative duration during an examination or procedure of operator-applied continuous pressure to the device, enabling x-ray tube activation in any fluoroscopic mode of operation.

(bq) “Fluoroscopic procedure” means the production and display of serial x-ray images for the purpose of observing real-time motion of anatomical structures.

(br) “Fluoroscopy” means a technique for generating x-ray images and presenting them simultaneously and continuously as visible images.

(bs) “Focal spot” means the actual focal spot area projected on the anode of the x-ray tube bombarded by the electrons accelerated from the cathode and from which the useful beam originates.

(bt) “General purpose radiographic x‑ray system” means any radiographic x-ray system which, by design, is not limited to radiographic examination of specific anatomical regions.

(bu) “Gonad shield” means a protective barrier for the testes or ovaries.

(bv) “Half-value layer (HVL)” means the thickness of specified material which attenuates the beam of radiation to an extent such that the exposure rate is reduced to one-half of its original value and for which the contribution of all scattered radiation, other than any which might be present initially in the beam concerned, is deemed to be excluded.

(bw) “Hand-held x-ray equipment” means x-ray equipment that is designed to be hand-held during operation.

(bx) “Healing arts screening” means the testing of human beings using x-ray machines for the detection or evaluation of health indications when such tests are not specifically and individually ordered by a licensed practitioner of the healing arts legally authorized to prescribe such x-ray tests for the purpose of diagnosis or treatment.

(by) “Heat unit” means a unit of energy equal to the product of the peak kilovoltage, milliamperes, and seconds.

(bz) “Image intensifier” means a device, installed in its housing, which instantaneously converts an x-ray pattern into a corresponding light image of higher intensity.

(ca) “Image quality” means the exactness of a 2-dimensional representation of the patient’s anatomy on the radiographic image.

(cb) “Image receptor” means any device, such as a fluorescent screen or radiographic film, which transforms incident x-ray photons either into a visible image or into another form which can be made into a visible image by further transformations.

(cc) “Image receptor support device” means, for mammographic systems, that part of the system designed to support the image receptor in a horizontal plane during mammography.

(cd) “Inherent filtration” means the filtration of the useful beam provided by the permanently installed components of the tube housing assembly.

(ce) “Interventional procedures” means procedures that utilize imaging for guidance. Imaging includes, but is not limited to, fluoroscopy and CT scan.

(cf) “Irradiation” means the exposure of matter to ionizing radiation.

(cg) “Isocenter” means the center of the smallest sphere through which the beam axis passes when the equipment moves through a full range of rotations about a common center.

(ch) “Kerma” means the quantity as defined by the International Commission on Radiation Units and Measurements. The kerma, K, is the quotient of dE_tr by dm, where dE_tr is the sum of the initial kinetic energies of the all charged particles liberated by the uncharged particles in mass dm of material thus K=dE_tr/dm in units of J/kg, where the special name for the unit of kerma is gray (Gy). When the material is air, the quantity is referred to as “air kerma.”

(ci) “Kilovolts peak (kVp)” means “peak tube potential”.

(cj) “kV” means kilovolts, which is 1,000 volts.

(ck) “kWs” means kilowatt-second which is equivalent to 10³ watt-second where 1 watt-second = kV × mA × second.

(cl) “Last image hold (LIH) radiograph” means an image obtained either by retaining one or more fluoroscopic images, which can be temporarily integrated, at the end of a fluoroscopic exposure or by initiating a separate and distinct radiographic exposure automatically and immediately in conjunction with termination of the fluoroscopic exposure.

(cm) “Lateral fluoroscope” means the x-ray tube and image receptor combination in a biplane system dedicated to the lateral projection. It consists of the lateral x-ray tube housing assembly and the lateral image receptor that are fixed in position relative to the table with the x-ray beam axis parallel to the plane of the table.

(cn) “Lead equivalent” means the thickness of lead affording the same attenuation, under specified conditions, as the material in question.

(co) “Leakage radiation” means radiation emanating from the diagnostic or therapeutic source assembly other than the useful beam and radiation produced when the exposure switch or timer is not activated.

(cp) “Leakage technique factors” means the technique factors associated with the diagnostic or therapeutic x-ray source assembly which are used in measuring leakage and are defined as follows:

(1) For diagnostic source assemblies intended for capacitor energy storage equipment, the maximum-rated peak tube potential and the maximum-rated number of exposures in a hour for operation at the maximum-rated peak tube potential with the quantity of charge per exposure being 10 millicoulombs or the minimum obtainable from the unit, whichever is larger;

(2) For diagnostic source assemblies intended for field emission equipment rated for pulsed operation, the maximum-rated peak tube potential and the maximum-rated number of x-ray pulses in an hour for operation at the maximum-rated peak tube potential; and

(3) For all other diagnostic source assemblies, the maximum-rated peak tube potential and the maximum-rated continuous tube current for the maximum-rated peak tube potential.

(cq) “Lease” means a machine that is possessed and used for a specified term in exchange for consideration. The term includes “rental.”

(cr) “Light field” means that area of the intersection of the light beam from the beam-limiting device and one of the set of planes parallel to and including the plane of the image receptor, whose perimeter is the locus of points at which the illumination is one-fourth of the maximum in the intersection.

(cs) “Line-voltage regulation” means the difference between the no-load and the load line potentials expressed as a percent of the load line potential calculated using the following equation:

Percent line-voltage regulation =

where:

V_N = No-load line potential; and

V_L= Load line potential.

(ct) “Loaner” means a machine that is a replacement for a registered machine that is being repaired, calibrated, or both. A loaner shall not include a machine that is purchased as a replacement for a registered machine.

(cu) “mA” means milliampere, which is 1/1,000 of an ampere.

(cv) “Magnetic resonance imaging scanner” means a diagnostic tool using a combination of magnetic fields and radio frequency waves to create cross-sectional images of the body.

(cw) “Magnetic resonance imaging (MRI)” means a non-invasive diagnostic procedure used to create cross-sectional images of the body by use of magnetic fields and radio frequency fields.

(cx) “Mammo-tomo” means breast tomosynthesis in which the x-ray tube moves in an arch during the exposure. The term includes “three dimensional breast imaging.”

(cy) “mAs” means milliampere second, which is 1/1,000 of an ampere second.

(cz) “Maximum line current” means the root-mean-square current in the supply line of an x-ray machine operating at its maximum rating.

(da) “Micro computed tomography” (Micro CT) means a scanning method that uses x-rays to create cross-sections of a physical object that can be used to recreate a virtual, 3-dimensional model. The pixel sizes of the cross-sections generated with this method are in the micrometer range. The term includes “high-resolution x-ray tomography.”

(db) “Mobile MRI unit” means a magnetic resonance imaging scanner that is approved by the federal Food and Drug Administration for the provision of diagnostic MRI services and which is physically located in a vehicle such as a self-contained van or tractor trailer for the purpose of transporting the magnetic resonance imaging scanner from one site to another.

(dc) “Mobile x-ray equipment” means x-ray equipment mounted on a permanent base with wheels and/or casters for moving while completely assembled.

(dd) “Multiple tomogram system” means a computed tomography x-ray system which obtains x-ray transmission data simultaneously during a single scan to produce more than one tomogram.

(de) “Noise” means the standard deviation of the fluctuations in CTN expressed as a percentage of the attenuation coefficient of water and is calculated using the following equation:

where:

CS= Contrast scale;

μ_w = Linear attenuation coefficient of water; and

s = Standard deviation of the CTN of picture elements in a specified area of the CT image.

(df) “Nominal tomographic section thickness” means the full width at half-maximum of the sensitivity profile taken at the center of the cross-sectional volume over which x-ray transmission data are collected.

(dg) “O-Arm” means a mobile fluoroscope, operated as a C-arm fluoroscope, which is opened and positioned over the area of interest on the patient being examined then closed around the patient to facilitate 360-degree x-ray imaging.

(dh) “Patient” means an individual or animal subjected to healing arts examination, diagnosis, or treatment.

(di) “Peak tube potential” means the maximum value of the potential difference across the x-ray tube during an exposure.

(dj) “Phantom” means a volume of material with an atomic number (Z) and density similar to biological tissue, which behaves in a manner similar to tissue with respect to the attenuation and scattering of radiation.

(dk) “Physician assistant” means a person licensed as a physician assistant by the New Hampshire board of medicine.

(dl) “Phototimer” means a method for controlling radiation exposure to image receptors by the amount of radiation which reaches a radiation monitoring device(s) that is part of an electronic circuit which controls the duration of time the tube is activated.

(dm) “Picture element” means an elemental area of a tomogram.

(dn) “Portable x-ray equipment” means x-ray equipment designed to be hand carried.

(do) “Position indicating device (PID)” means a device on dental x-ray equipment used to indicate the beam position and to establish a definite source-surface (skin) distance. It may or may not incorporate or serve as a beam-limiting device.

(dp) “Positive beam limitation (PBL)” means the automatic or semi-automatic adjustment of an x-ray beam to the size of the selected image receptor, whereby exposures cannot be made without such adjustment.

(dq) “Primary protective barrier” means the material, excluding filters, placed in the useful beam, for protection purposes, to reduce the radiation exposure.

(dr) “Protective apron” means an apron made of radiation absorbing materials used to reduce radiation exposure.

(ds) “Protective barrier” means a barrier of radiation absorbing material(s) used to reduce radiation exposure.

(dt) “Protective glove” means a glove of radiation absorbing materials used to reduce radiation exposure.

(du) “Pulsed mode” means operation of the x-ray system such that the x-ray tube current is pulsed by the x-ray control to produce one or more exposure intervals of duration less than one-half second.

(dv) “Quality assurance” means a program providing for verification by written procedures such as testing, auditing, and inspection to ensure that deficiencies, deviations, defective equipment, or unsafe practices, or a combination thereof, relating to the use, disposal, management, or manufacture of radiation devices are identified, promptly corrected and reported to the appropriate regulatory authorities.

(dw) “Qualified expert” means an individual who has demonstrated to the satisfaction of DHHS/RHS that such individual possesses the knowledge, skills, and training to measure ionizing radiation to evaluate radiation parameters, to evaluate safety techniques and to advise regarding radiation protection needs as described in He-P 4040.

(dx) “Radiation detector” means a device which in the presence of radiation provides a signal or other indication suitable for use in measuring one or more quantities of incident radiation.

(dy) “Radiation therapy simulation system” means a radiographic or fluoroscopic x-ray system intended for localizing the volume to be exposed during radiation therapy and confirming the position and size of the therapeutic irradiation field.

(dz) “Radiograph” means an image receptor on which the image is created directly or indirectly by an x-ray pattern and results in a permanent record.

(ea) “Radiographic imaging system” means any system whereby a permanent or semi-permanent image is recorded on an image receptor by the action of ionizing radiation.

(eb) “Rated line voltage” means the range of potentials, in volts, of the supply line specified by the manufacturer at which the x-ray machine is designed to operate.

(ec) “Rated output current” means the maximum allowable load current of the x-ray high-voltage generator.

(ed) “Rating” means the operating limits as specified by the component manufacturer.

(ee) “Recording” means producing a permanent form of an image resulting from x-ray photons.

(ef) “Reference plane” means a plane which is displaced from and parallel to the tomographic plane.

(eg) “Resolution” means the ability to image 2 separate objects and visually distinguish one from the other.

(eh) “Response time” means the time required for an instrument system to reach 90 percent of its final reading when the radiation‑sensitive volume of the instrument system is exposed to a step change in radiation flux from zero sufficient to provide a steady state mid-scale reading.

(ei) “Scan” means the complete process of collecting x-ray transmission data for the production of a tomogram which may be collected simultaneously during a single scan for the production of one or more tomograms.

(ej) “Scan increment” means the amount of relative displacement of the patient with respect to the CT x-ray system between successive scans measured along the direction of such displacement.

(ek) “Scan sequence” means a pre-selected set of two or more scans performed consecutively under pre-selected CT conditions of operation.

(el) “Scan time” means the period of time between the beginning and end of x-ray transmission data accumulation for a single scan.

(em) “Scattered radiation” means radiation that, during passage through matter, has been deviated in direction.

(en) “Secondary dose monitoring system” means a system that will terminate irradiation in the event of a failure of the primary system.

(eo) “Secondary protective barrier” means a barrier sufficient to attenuate the stray radiation to the required degree.

(ep) “Shutter” means a device attached to the tube housing assembly which can intercept the entire cross-sectional area of the useful beam and which has a lead equivalency not less than that of the tube housing assembly.

(eq) “Single tomogram system” means a CT x-ray system which obtains x-ray transmission data during a scan to produce a single tomogram.

(er) “Spatial frequency” means a measure of the changes in tissue attenuation characteristics. Abrupt changes have high spatial frequency, such as bone-lung interface, and gradual changes, such as liver-spleen interface, have low spatial frequency. Spatial frequency is expressed as line pair per millimeter (lp/mm).

(es) “Spatial resolution” means the ability to image anatomical structures or small objects that have high subject contrast, such as bone versus soft tissue.

(et) “Solid state x-ray imaging device” means an assembly, typically in a rectangular panel configuration, that intercepts x-ray photons and converts the photon energy into a modulated electronic signature representative of the x-ray intensity over the area of the imaging device. The electronic signal is then used to create an image for display, storage or both.

(eu) “Source” means the focal spot of the x-ray tube.

(ev) “Source-image receptor distance (SID)” means the distance from the source to the center of the input surface of the image receptor.

(ew) “Source-skin distance (SSD)” means the distance from the source to the center of the entrant x-ray field in the plane tangent to the patient skin surface.

(ex) “Spot check” means an abbreviated calibration procedure which is performed to assure that a previous calibration continues to be valid.

(ey) “Spot film” means a radiograph which is made during a fluoroscopic examination to permanently record conditions which exist during that fluoroscopic procedure.

(ez) “Spot-film device” means a device intended to transport and/or position a radiographic image receptor between the x-ray source and fluoroscopic image receptor and includes a device intended to hold a cassette over the input end of an image intensifier for the purpose of making a radiograph.

(fa) “Stationary x-ray equipment” means x-ray equipment which is installed in a fixed location.

(fb) “Stray radiation” means the sum of leakage and scattered radiation.

(fc) “Supervising physician” means a physician who holds a current license issued by the New Hampshire board of medicine and who supervises all professional activities of a physician assistant.

(fd) “Technique factors” means the following conditions of operation:

(1) For capacitor energy storage equipment, peak tube potential in kV and quantity of charge in mAs;

(2) For field emission equipment rated for pulsed operation, peak tube potential in kV, and number of x-ray pulses;

(3) For CT x-ray systems designed for pulsed operation, peak tube potential in kV, scan time in seconds, and either tube current in mA, x-ray pulse width in seconds, and the number of x-ray pulses per scan, or the product of tube current, x-ray pulse width, and the number of x-ray pulses in mAs;

(4) For CT x-ray systems not designed for pulsed operation, peak tube potential in kV, and either tube current in mA and scan time in seconds, or the product of tube current and exposure time in mAs and the scan time when the scan time and exposure time are equivalent; and

(5) For all other equipment, peak tube potential in kV, and either tube current in mA and exposure time in seconds, or the product of tube current and exposure time in mAs.

(fe) “Tenth-value layer (TVL)” means the thickness of a specified material which attenuates x-radiation or gamma radiation to an extent such that the air kerma rate, exposure rate, or absorbed dose rate is reduced to one-tenth of the value measured without the material at the same point.

(ff) “Termination of irradiation” means the stopping of irradiation in a fashion which will not permit continuance of irradiation without the resetting of operating conditions at the control panel.

(fg) “Transmission system” means a security screening system using the conventional means of radiographic imaging in which x-rays pass through a target, such as a person or object and create shadow-grams of enclosed objects, such as contraband, based on their radiation attenuating properties.

(fh) “Tomogram” means the depiction of the x-ray attenuation properties of a section through the body.

(fi) “Tomographic plane” means that geometric plane which is identified as corresponding to the output tomogram.

(fj) “Tomographic section” means the volume of an object whose x-ray attenuation properties are imaged.

(fk) “Tube” means an x‑ray tube, unless otherwise specified.

(fl) “Tube housing assembly” means the tube housing with tube installed to include the high-voltage and/or filament transformers and other appropriate elements when such are contained within the tube housing.

(fm) “Tube rating chart” means the set of curves which specify the rated limits of operation of the tube in terms of the technique factors.

(fn) “Useful beam” means the radiation which passes through the tube housing port and the aperture of the beam-limiting device when the exposure switch or timer is activated.

(fo) “Variable-aperture beam-limiting device” means a beam-limiting device which has capacity for stepless adjustment of the x-ray field size at a given SID.

(fp) “Visible area” means that portion of the input surface of the image receptor over which incident x-ray photons are producing a visible image.

(fq) “Wedge filter” means an added filter effecting continuous progressive attenuation on all or part of the useful beam.

(fr) “X-ray diffraction (XRD)” means the analysis of the characteristic atomic pattern of x-rays scattered when the primary beam from the machine strikes the sample.

(fs) “X-ray exposure control” means a device, switch, button or other similar means by which an operator initiates and/or terminates the radiation exposure and may include such associated equipment as timers and back-up timers.

(ft) “X-ray equipment” means an x-ray system, subsystem, or component thereof.

(fu) “X-ray field” means that area of the intersection of the useful beam and any one of the set of planes parallel to and including the plane of the image receptor, whose perimeter is the locus of points at which the exposure rate is one-fourth of the maximum in the intersection.

(fv) “X-ray fluorescence (XRF)” means the analysis of the characteristic x-rays created when the primary beam from the machine strikes the sample.

(fw) “X-ray high-voltage generator” means a device which transforms electrical energy from the potential supplied by the x-ray control to the tube operating potential and may include a means for transforming alternating current to direct current, filament transformers for the x-ray tube(s), high-voltage switches, electrical protective devices, and other appropriate elements.

(fx) “X-ray reciprocity” means any business entity proposing to bring a radiation machine into this state from another state for operation only by the business entity, except in areas of exclusive federal jurisdiction, for a period not in excess of 180 days in any calendar year.

(fy) “X-ray subsystem” means any combination of two or more components of an x-ray system for which there are requirements specified in this section.

(fz) “X-ray system” means an assemblage of components for the controlled production of x-rays and includes as a minimum an x-ray high-voltage generator, an x-ray control, a tube housing assembly, a beam‑limiting device, and the necessary supporting structures and may include additional components which function with the system which are considered integral parts of the system.

(ga) “X-ray table” means a patient support device with its patient support structure or tabletop interposed between the patient and the image receptor during radiography or fluoroscopy and may include any stretcher equipped with a radiolucent panel or any table equipped with a cassette tray (bucky), cassette tunnel, image intensifier, or spot-film device beneath the tabletop.

(gb) “X-ray tube” means any electron tube which is designed to be used primarily for the production of x-rays.

Source. #6827, eff 8-6-98; ss by #8692, INTERIM, eff 7-27-06, EXPIRES: 2-2-07; ss by #8808, eff 1-24-07; ss by #10806, eff 3-28-15; paras (n), (o), (eo) and (fh) amd by #12024, INTERIM, eff 10-28-16, EXPIRED: 4-26-17; paras (n), (o), (eo) and (fh) amd by #12215, eff 6-20-17; ss by #14300, eff 7-1-25, EXPIRES: 7-1-35

PART He-P 4042 - RESERVED

PART He-P 4043 RADIATION SAFETY REQUIREMENTS FOR NON-HEALING ARTS RADIATION GENERATING DEVICES (RGD)

He-P 4043.01 Purpose. This part provides special requirements for non-healing arts radiation generating devices (RGDs) operating between 5 kiloelectron volts (keV) and 1 million electron volts (MeV). For machines operating at energies greater than 1 MeV, see He-P 4044, “Radiation Safety Requirements for Particle Accelerators” of these regulations.

Source. #6827, eff 8-6-98; ss by #8692, INTERIM, eff 7-27-06, EXPIRES: 2-2-07; ss by #8808, eff 1-24-07; ss by #10804, eff 3-26-15; ss by #14336, eff 8-8-25; EXPIRES: 8-8-35

He-P 4043.02 Scope. The requirements of this Part are in addition to, and not in substitution for, requirements in other Parts of these rules.

Source. #6827, eff 8-6-98; ss by #8692, INTERIM, eff 7-27-06, EXPIRES: 2-2-07; ss by #8808, eff 1-24-07; ss by #10804, eff 3-26-15; ss by #14336, eff 8-8-25; EXPIRES: 8-8-35

He-P 4043.03 Definitions.

(a) “Analytical x-ray equipment” means equipment used for x-ray diffraction or fluorescence analysis.

(b) “Baggage unit” means a cabinet x-ray system with accessible openings designed for the detection of weapons, bombs, or contraband concealed in baggage, mail, packages, or other commodities or structure.

(c) “Beam-port” means an opening on the x-ray apparatus designed to emit a primary beam. This does not include openings on baggage units.

(d) “Bomb detection radiographic equipment” means x-ray generating equipment used solely for the purpose of remotely detecting explosive devices. This definition does not include hand-held x-ray bomb detection equipment for the purposes of this Part.

(e) “Cabinet radiography” means industrial radiography using radiation machines not subject to Food and Drug Administration performance standard for cabinet x-ray systems, in an enclosed, interlocked cabinet in which the portion of a material being irradiated is contained, and in which:

(1) The radiation machine will not operate unless all openings are closed with interlocks activated;

(2) The cabinet is shielded such that every location on the exterior meets the conditions for an

unrestricted area as defined in He-P 4003.01(fs); and

(3) The cabinet is constructed or arranged as to exclude the entrance of any part of the body of an individual during irradiation.

(f) “Cabinet x-ray system” means an x-ray system with the x-ray tube installed in an enclosure which, independently of existing architectural structures except the floor on which it may be placed, is intended to contain at least that portion of a material being irradiated, provide radiation attenuation, and exclude personnel from its interior during generation of x radiation. Included are all x-ray systems designed primarily for the inspection of carry-on baggage at airline, railroad, and bus terminals, and in similar facilities. An x-ray tube used within a shielded part of a building, or x-ray equipment which may temporarily or occasionally incorporate portable shielding, is not a cabinet x-ray system.

(g) “Cathode ray tube” means any device used to accelerate electrons for demonstration or research purposes, except where such cathode ray tube is incorporated into a television or display monitor that is subject to, and has met applicable federal radiation safety performance standards in 21 CFR 1010 and 21 CFR 1020.10.

(h) “Certified cabinet x-ray system” means a radiation generating device (RGD) certified by the manufacturer in accordance with 21 CFR 1010.2 as being manufactured and assembled pursuant to the provisions of applicable federal radiation safety performance standards 21 CFR 1010 and 21 CFR 1020.40.

(i) “Certifiable cabinet x-ray system” means an existing uncertified RGD that has been modified to meet the certification requirements specified in 21 CFR 1020.40.

(j) “Closed-beam x-ray equipment” means a system in which the beam path cannot be entered by any part of the body during normal operation.

(k) “Cold-cathode gas discharge tube” means an electronic device in which electron flow is produced and sustained by ionization of contained gas atoms and ion bombardment of the cathode.

(l) “Electron microscope” means electronic equipment that produces radiation incidental to its operation and which is not exempt from registration under the provision of He-P 4040.05(a). The term includes “transmission electron microscope” and “scanning electron microscope”.

(m) “Fail-safe design” means a design in which all realistically anticipated failures of indicators or safety components result in a condition in which individuals are safe from exposure to radiation.

(n) “General-use system” means a personnel screening system that delivers an effective dose equal to or less than 0.25 μSv (25 μrem) per screening.

(o) “Hand-held x-ray system” means a portable instrument that is designed to operate when held in the hand, such as hand-held XRF analtytical devices.

(p) “Limited-use system” means a personnel screening system that is capable of delivering an effective dose greater than 0.25 μSv (25 μrem) per screening but cannot exceed an effective dose of 10 μSv (1 mrem) per screening.

(q) “Local components” means parts of an RGD and includes areas that are struck by x-rays such as radiation source housings, port and shutter assemblies, collimators, sample holders, cameras, goniometers, detectors, and shielding, but do not include power supplies, transformers, amplifiers, readout devices, and control panels.

(r) “Normal operating procedures” means step-by-step instructions necessary to accomplish the analysis. These procedures include sample insertion and manipulation, device alignment, routine maintenance by the registrant or licensee, and data recording procedures, which are related to radiation safety.

(s) “Open-beam configuration” means an open-beam x-ray system in which an individual could accidentally place some part of their body in the primary beam path during normal operation.

(t) “Radiation generating device (RGD)” means any system, device, subsystem, or component thereof, which generate x-rays or particle radiation between 5 keV and 1 MeV, and is not intended for healing arts use for humans or animals.

(u) “Safety device” means a device, interlock, or system that prevents the entry of any portion of an individual’s body into the primary x-ray beam path or which causes the beam to be shut off upon entry into its path.

(v) “Security screening unit” means a non-human use open-beam or cabinet x-ray system with accessible openings designed for the detection of weapons, bombs, or contraband concealed in baggage, mail, packages, or other commodities or structure.

(w) “Shielded room” means a room housing an RGD where, with the RGD at maximum techniques, the exterior room environs meets the unrestricted area limits of 0.02 mSv (2 mrem) in any one hour and 1 mSv (100 mrem) in a year at 30 cm from the barrier. A shielded room does not include an RGD which meet the definition of cabinet x-ray systems.

(x) “X-ray gauge” means a radiation generating device designed and manufactured for the purpose of detecting, measuring, gauging or controlling thickness, density level, or interface location.

Source. #6827, eff 8-6-98; ss by #8692, INTERIM, eff 7-27-06, EXPIRES: 2-2-07; ss by #8808, eff 1-24-07; ss by #10804, eff 3-26-15; ss by #14336, eff 8-8-25, EXPIRES: 8-8-35

He-P 4043.04 Exemptions.

(a) RGDs meeting the definition of bomb detection radiation equipment, as defined under He-P 4043.03(d), are exempt from the requirements of He-P 4043.05(j).

(b) Unless utilized in a dedicated location, hand-held RGDs are exempt from the requirements of He-P 4043.05(j).

(1) Domestic television receivers, provided that the exposure rate at 5 centimeters from any outer surface is less than 0.005 mSv (0.5 mrem) per hour;

(2) Cold-cathode gas discharge tubes, providing the exposure rates shall not exceed 0.1 mSv (10 mrem) per hour at a distance of 30 centimeters from any point on the external surface of the tube; and

(3) Other electrical equipment that produces radiation incidental to its operation for other purposes, providing the dose rate to the whole body at the point of nearest approach to such equipment when any external shielding not integral to the equipment is removed does not exceed 0.25 mSv (25 mrem) per year.

(d) Equipment described in He-P 4043.04(c) shall not be exempt if it is used or handled in such a manner that any individual might receive a dose of radiation in excess of the limits specified in He-P 4020.

(e) The production testing or factory servicing for such equipment mentioned above in (c)(3) shall not be exempt.

Source. #6827, eff 8-6-98; ss by #8692, INTERIM, eff 7-27-06, EXPIRES: 2-2-07; ss by #8808, eff 1-24-07; ss by #10804, eff 3-26-15; ss by #14336, eff 8-8-25, EXPIRES: 8-8-35

He-P 4043.05 General Requirements for Non-Healing Arts Radiation Generating Devices (RGD).

(a) Unless otherwise provided in this Part, this section applies to all RGDs and certified and certifiable cabinet x-ray systems, both of which shall also meet the requirements of 21 CFR 1020.40.

(b) Warning devices shall:

(1) Be labeled so that their purpose is easily identified; and

(2) Contain an easily visible warning light labeled with the words "X-RAY ON" or other words having a similar intent. This warning light shall be located near any switch that energizes an x-ray tube and shall be illuminated only when the tube is energized and be of a fail-safe design.

(1) A readily visible and discernible sign or signs bearing the radiation symbol in accordance with He-P 4022.11 and the words: “CAUTION RADIATION - THIS EQUIPMENT PRODUCES RADIATION WHEN ENERGIZED,” or words having a similar intent, near any

switch that energizes an x-ray tube; and

(2) For RGDs with designed openings for object entries such as baggage units, the following language shall be posted at or near each opening: “CAUTION – X-RAY HAZARD: DO NOT INSERT ANY PART OF THE BODY WHEN SYSTEM IS ENERGIZED”, or words having similar intent.

(d) Each x-ray tube housing shall be subject to the following requirements:

(1) When the x-ray tube housing is the primary shielding for the x-ray tube, and is intended to be opened for normal use or maintenance, the housing shall be equipped with an interlock that shuts off the high voltage to the x-ray tube if the housing is opened; and

(2) Each x-ray tube housing shall be so constructed that, with all shutters closed, the leakage radiation measured at a distance of 5 centimeters from the x-ray tube housing surface does not exceed 0.025 mSv (2.5 mrem) per hour. This limit shall be met at the maximum tube rating.

(e) Each x-ray generator or high-voltage source shall be supplied with a protective cabinet which limits leakage radiation to 2.5 µSv (0.25 mrem) per hour at a distance of 5 centimeters measured at the nearest accessible surface.

(f) For closed-beam systems, the requirements in He-P 4043.05(d)(2) and 4043.05(e) shall be met by complying with He-P 4043.08(e).

(g) For an RGD in a shielded room, the requirements in He-P 4043.05(d)(2) and 4043.05(e) shall be met by measuring from any accessible surface outside the room housing the RGD.

(h) For hand-held, open-beam RGDs, the requirements in He-P 4043.05(d)(2) and 4043.05(e) shall be met by complying with the limits in He-P 4043.10(c).

(i) Radiation surveys of all RGDs shall be sufficient to show compliance with radiation emission requirements of this Part, and as required by He-P 4020.05, entitled “Occupational Dose Limits for Adults” and He-P 4020.13, entitled “Dose Limits for Individual Members of the Public”. At a minimum, surveys shall be performed:

(1) Upon installation of the equipment, and at least once every 12 months thereafter;

(2) Following any change in the initial arrangement, number, or type of local components in the system;

(3) Following any maintenance requiring the disassembly, removal, or repair of a local component in the system;

(4) During the performance of maintenance, calibration, and other procedures if the procedures require the presence of a primary x-ray beam while any local component in the system is disassembled or removed;

(5) Post bypass of a safety device or interlock as required by He-P 4043.06(a)-(f);

(6) Any time a visual inspection of the local components in the system reveals an abnormal condition; and

(7) Whenever a personnel monitoring device shows a significant increase over previous monitoring period or readings are approaching the limits specified in He-P 4020.05.

(j) Radiation survey measurements shall not be required if a registrant can otherwise demonstrate compliance with the requirements of this Part to the satisfaction of the department of health and human services radiological health section (DHHS/RHS).

(k) Each area or room containing an RGD where an individual might receive 0.02 mSv (2 mrem) in any one hour or 1 mSv (100 mrem) per year shall be conspicuously posted with a sign or signs bearing the radiation symbol and the words “CAUTION - X-RAY EQUIPMENT,” “CAUTION – RADIATION GENERATING DEVICE”, or words having a similar intent.

(l) RGDs shall be secured in such a way as to be accessible to, or operable by, only authorized personnel when not in operation.

Source. #6827, eff 8-6-98; ss by #8692, INTERIM, eff 7-27-06, EXPIRES: 2-2-07; ss by #8808, eff 1-24-07; ss by #10804, eff 3-26-15; ss by #14336, eff 8-8-25, EXPIRES: 8-8-35

He-P 4043.06 Operating Requirements.

(a) Normal and emergency operating procedures shall be written and available to all RGD workers.

(b) No individual shall be permitted to operate an RDG in any manner other than that specified in the procedures unless such individual has obtained written approval of the radiation safety officer, as defined in He-P 4003.01.

(c) No individual shall bypass a safety device, interlock, or remove shielding unless such individual has obtained written approval of the radiation safety officer.

(d) The written approval required in He-P 4043.06(b) and (c) shall be for a temporary period of time as determined by the radiation safety officer.

(e) When a safety device or interlock has been bypassed, a sign bearing the words “SAFETY DEVICE NOT WORKING” shall be placed on the radiation source housing and at the control switch.

(f) A record of any bypass of a safety device or interlock shall be maintained and the record shall contain such information as the following:

(1) The date the alteration was made;

(2) The type of alteration;

(3) The length of time the unit remained in the altered condition;

(4) The post bypass survey, signed by the radiation safety officer;

(5) The individual who made the alteration; and

(6) The individual who restored the unit to original condition.

(g) The RGD shall only be activated from a control panel.

(h) All indicators and controls that control the primary beam shall be identifiable and discernible through the use of labels, symbols, software displays, or the equivalent.

(i) An interlock shall not be used to de-activate the x-ray tube or RGD, except in an emergency or during testing of the interlock system.

(j) After triggering any interlock, it shall be possible to reset the RGD to full operation only from a control panel.

(k) All interlocks shall be of a fail-safe design.

(l) If more than one x-ray tube assembly or focal spot can be operated sequentially or simultaneously from a control panel, visual indicators shall identify which tube assembly or focal spot has been selected. The selectors shall be identified as to their function. If a letter or number is used, a reference card or table explaining the code shall be affixed to the control panel.

(m) Only trained personnel or a registered service provider shall be permitted to install, repair, or make modifications to the RGD. No operation involving removal of covers, shielding materials, or tube housings, or modifications to shutters, collimators, or beam stops shall be performed without ascertaining that the tube is off and will remain off until safe conditions have been restored. The main power switch with a lock-out / tag-out, rather than interlocks, shall be used for routine shutdown in preparation for repairs. It is the responsibility of the registrant to assure that qualified personnel install, repair, or make modifications to the RGD.

(n) The testing of safety devices shall be subject to the following requirements:

(1) Tests of all safety devices, such as interlocks, shutters, warning lights, and required emergency shut-off switches shall be conducted at intervals not to exceed 6 months on all operable RGDs;

(2) If any safety device fails during testing, the RGD shall be removed from service until the safety device failure is corrected or proper temporary administrative controls established and approved in writing by the radiation safety officer;

(3) Records of safety device tests, check dates, findings, and documentation of any corrective action shall be available during the inspection and maintained for 5 years;

(4) Records shall include the date of the test, a list of the safety devices tested, survey instrument information, calibration date, the results of the test, the name of the person performing the tests, and documentation of any corrective action taken for safety devices that fail the required test;

(5) Testing of safety devices may be deferred if the unit or installation is clearly marked and kept out of service. Units or installations brought back into service after exceeding the 6 month interval shall be tested prior to use; and

(6) If testing of a safety device cannot be performed due to manufacturer design, the registrant shall document that the safety device will not be tested and specifically state why the safety device cannot be tested.

Source. #6827, eff 8-6-98; ss by #8692, INTERIM, eff 7-27-06, EXPIRES: 2-2-07; ss by #8808, eff 1-24-07; ss by #10804, eff 3-26-15; ss by #14336, eff 8-8-25, EXPIRES: 8-8-35

He-P 4043.07 Personnel Requirements.

(a) The registrant shall document the scope of training required for the RGD they possess.

(b) No individual shall be permitted to operate or maintain an RGD unless such individual has received instruction and demonstrated competence in:

(1) Identification of radiation hazards associated with the use of the RDG, associated equipment, or measures to minimize radiation exposure;

(2) The significance of the various radiation warning devices, safety devices, and interlocks incorporated into the equipment, or the reasons such devices have not been installed on certain equipment;

(3) Any extra precautions required relevant to the use of the equipment;

(4) Normal operating procedures for each type of RGD and associated equipment,

including having received hands-on training and education regarding procedures to prevent unauthorized use;

(5) Biological effects of radiation, radiation risks, and recognition of symptoms of an acute localized exposure commensurate with the potential hazards of use;

(6) Proper procedures for reporting an actual or suspected exposure or other radiation safety concerns, such as any unusual occurrence or malfunction that might involve exposure to radiation; and

(7) Performing surveys where applicable.

(c) Records shall be maintained onsite of all required training and instruction and made available to DHHS/RHS for review.

(d) The registrant's senior management shall make the ultimate decision to use any RGD and be ultimately responsible for radiation safety.

(e) The registrant's senior management shall designate an individual responsible for radiation safety, or a radiation safety officer. This individual shall have direct access to senior management for radiation safety issues. This individual shall have training and experience commensurate with the scope of the radiation safety program to carry out the responsibilities as indicated below:

(1) Ensuring that all RGDs are operated within the limitations of the established radiation safety program and operating procedures;

(2) Instructing personnel with regard to safe working practices and ensuring all personnel are trained in radiation safety commensurate with the hazards of the job;

(3) Investigating any incident of abnormal operation or exposure or suspected overexposure of personnel to determine the cause, take remedial action, and report the incident to the proper authority;

(4) Ensuring that safety devices, interlocks, warning signals, labels, postings, and signs are functioning and located where required; and

(5) Maintain all radiation safety records.

Source. #6827, eff 8-6-98; ss by #8692, INTERIM, eff 7-27-06, EXPIRES: 2-2-07; ss by #8808, eff 1-24-07; ss by #10804, eff 3-26-15; ss by #14336, eff 8-8-25, EXPIRES: 8-8-35

He-P 4043.08 Additional Requirements for Closed-Beam RGDs.

(a) The radiation source, sample or object, detector, and analyzing crystal, if used, shall be enclosed in a chamber or coupled chambers that cannot be entered by any part of the body during normal operation.

(b) All doors and panels accessing the RGDs shall be interlocked.

(c) The system enclosure shall be interlocked with either the x–ray tube high voltage supply or a shutter in the primary beam, or both, so that no x-ray beam can enter the sample or object chamber while it is open unless the interlock has been conspicuously and deliberately defeated.

(d) Adequate administrative controls shall be exercised to ensure operations will not continue without a proper functioning interlock.

(e) The radiation emission for all closed beam RGDs shall not exceed a dose rate of 0.005 mSv (0.5 mrem) in one hour at 5 centimeters outside any accessible surface.

(f) Baggage units shall be provided with means to ensure operator presence at the control area in a position which permits surveillance of the openings and doors during generation of x-radiation. The operator shall also be provided with means to:

(1) Enable the operator to terminate the exposure or preset succession of exposures at any time during an exposure or preset succession of exposures of one-half second or greater duration; and

(2) Allow completion of the exposure in progress but enable the operator to prevent additional exposures during an exposure or preset succession of exposures of less than one-half second duration.

Source. #14336, eff 8-8-25, EXPIRES: 8-8-35

He-P 4043.09 Additional Requirements for Open Beam RGDs.

(a) All open-beam configurations shall be provided with a safety device which prevents the entry of any portion of an individual’s body into the primary x-ray beam path or which causes the beam to be shut off upon entry into its path.

(b) The registrant shall document their justification of the use of open-beam instead of

closed-beam systems.

(c) If the registrant’s use of the open-beam RGD does not permit the use of a safety device to prevent direct body exposure the registrant shall document:

(1) A description of the various safety devices that have been evaluated;

(2) The reason each of these devices cannot be used;

(3) A description of the alternative methods that will be employed to minimize the possibility of an accidental exposure; and

(4) The procedures followed to assure that operators and others in the area will be informed of the absence of safety devices.

(d) The registrant shall maintain documentation required by He-P 4043.09(c) for as long as those methods are employed plus an additional 5 years.

(e) For portable open-beam RGDs that are manufactured to be used hand-held, or potentially used as a hand-held, without such safety devices, this safety device requirement may be met by complying with all the requirements in He-P 4043.10 prior to use.

(f) All open-beam configurations shall contain a warning device.

(g) Each open-beam RGD shall have an easily visible warning light labeled with the words “X-RAY ON” located near any switch that energizes an x-ray tube.

(h) The warning device required in He-P 4043.09(f) shall:

(1) Indicate the x-ray tube “on-off” status and be located near the radiation source housing, if the light required by He-P 4043.09(g) is not readily discernable and viewable by anyone near the primary beam; and

(2) Indicate the shutter “open-closed” status at the control panel and near each beam port on the radiation source housing, if the primary beam is controlled by a shutter. A shutter “open-closed” status light at the control panel, alone, is adequate provided the light is readily discernable and viewable by anyone near the primary beam.

(i) The warning light required in He-P 4043.09(g) shall be illuminated only when the x-ray tube is energized.

(j) The warning light described in He-P 4043.09(h)(2) shall be illuminated only when the shutter is open.

(k) Any unused port on a radiation machine source housing shall be secured in the closed position in such a manner as to prevent casual opening.

(l) On open-beam RGD configurations that are designed to accommodate interchangeable components, each beam port on the radiation source housing shall be equipped with a shutter that cannot be opened unless a collimator or a component coupling has been connected to the beam port.

(m) The local components of an open-beam RGD shall be located and arranged, and shall include sufficient shielding or access control, such that no radiation emissions exist, exclusive of the primary beam, in any area surrounding the local component group which could result in a dose to an individual present in excess of the dose limits as outlined in He-P 4020.13. These emissions shall be met at any specified tube rating.

(n) In cases where the primary x-ray beam is not intercepted by the detector device under all conditions of operation, protective measures shall be provided, such as auxiliary shielding or administrative procedures, to avoid exposure to any individual from the transmitted primary x-ray beam.

(o) The operator shall be in immediate attendance at all times when the equipment is in operation except when the area is locked or the equipment is secured to protect against unauthorized or accidental entry.

(p) If the RGD is not in a restricted area, as defined in He-P 4003.01, the operator shall be able to control access to the RGD at all times during operation. If the RGD is not in a restricted area and the RGD is capable of creating a radiation area or a high radiation area, the operator shall be able to control access to the RGD at all times during operation, and:

(1) Radiation areas shall be conspicuously identified. The radiation source shall be within a conspicuous perimeter, such as rope, tape, or other barrier, that identifies the area in which the dose equivalent rate exceeds 0.05 mSv (5 mrem) per hour. The area described by the temporary barricade shall be suitably posted with “CAUTION - RADIATION AREA” signs. The operator shall ensure that no one is inside or enters the radiation area during operation of the RGD;

(2) High radiation areas shall be conspicuously identified. The radiation source shall be within a conspicuous perimeter, such as rope, tape, or other barrier, that identifies the area in which the dose equivalent rate exceeds 1 mSv (100 mrem) per hour. The area described by the temporary barricade shall be suitably posted with “CAUTION - HIGH RADIATION AREA” signs. The operator shall ensure that no one is inside or enters the high radiation area during operation of the RGD;

(3) The operator shall perform a visual check of the controlled area to ensure it is free of all unauthorized personnel immediately prior to activating or exposing the radiation source;

(4) Surveillance of the exposure area shall be maintained during operation, either by visual or by other reliable means to ensure that no person enters the area;

(5) With the exception of hand-held x-ray systems, when approaching the radiation source, following the conclusion of an exposure, the operator shall use a suitable calibrated and operable radiation detection instrument to verify that the radiation source is in its fully shielded condition or that the x-ray tube has been de-energized;

(6) Measurement of radiation levels for a radiation survey shall be performed using an appropriate calibrated radiation survey meter. A radiation survey meter shall also be used when there is potential for non-uniform exposure to personnel, such as might occur during machine maintenance or work in a RGD target area;

(7) During the initial exposure, the radiation levels shall be measured around the perimeter of the controlled area. The perimeter shall be adjusted accordingly to meet the access control requirement for radiation areas or high radiation areas; and

(8) The survey around the perimeter shall be made for each new operating condition and the perimeter adjusted accordingly. The area of operation shall be monitored periodically if radiation levels are variable.

(q) In addition to the requirements in He-P 4043.07, no individual shall be permitted to operate or maintain an open-beam RGD unless such individual has received more specific and detailed instruction in and demonstrated competence as to:

(1) Sources and magnitude of common radiation exposure;

(2) Units of radiation measurement;

(3) Radiation protection concepts of time, distance, shielding, and as low as reasonably achievable (ALARA);

(4) Procedures and rights of a declared pregnancy;

(5) Regulatory requirements and area postings;

(6) Worker, embryo/fetus, and public dose limits;

(7) Proper use of survey instruments and dosimetry; and

(8) The requirements of He-P 4043.09(a)-(e).

(r) Any individual working with or routinely working near and having potential for exposure to the primary beam of an open-beam RGD shall be provided with extremity dosimetry.

(s) Personnel maintaining RGDs shall be provided with extremity dosimetry if the maintenance procedures require the presence of a primary x-ray beam when any local component in the analytical x-ray system is disassembled or removed.

Source. #14336, eff 8-8-25, EXPIRES: 8-8-35

He-P 4043.10 Additional Requirements for Open Beam, Hand-held RGDs. In addition to the requirements in He-P 4043.05, He-P 4043.06, and He-P 4043.07, the following requirements in this Section apply to open-beam, hand-held RGDs:

(a) All registrants possessing open-beam, hand-held RGDs shall have available to DHHS/RHS for review all operating policies and procedures that contain measures to insure that:

(1) Radiation protection is provided equivalent to that afforded in He-P 4020.13;

(2) Radiation protection is provided equivalent to that afforded in He-P 4043.09(n);

(3) The operator will not hold the sample during operation of the RGD and that the operator’s hands will not approach the primary beam;

(4) The operator will not aim the primary beam at themselves or at any individual during operation of the RGD; and

(5) Operator radiation exposure is ALARA, for example, by use of ancillary equipment that will reduce exposure;

(b) In addition to the training requirements of He-P 4043.07(b) and He-P 4043.09(q) above, the registrant shall provide training for all users and operators on the subjects in He-P 4043.10(a). Records shall be maintained of all user and operator training;

(c) For hand-held RGDs, the limits of He-P 4043.05(c)(2) and He-P 4043.05(d)(2), excluding the primary beam, shall be met if the radiation emission at any accessible surface of the RGD does not exceed 0.025 mSv (2.5 mrem) per hour at 5 cm; and

(d) For the purposes of the requirements in He-P 4043.09(r), operators of hand-held RGDs shall be considered as working near the primary beam.

Source. #14336, eff 8-8-25, EXPIRES: 8-8-35

He-P 4043.11 Shielded Room RGDs. For RGDs that do not meet the limits of He-P 4020.13, the RGD can be maintained inside a shielded room such that the exterior of the room meets the limits of He-P 4020.13 when the RGD is activated. RGDs in a shielded room shall be required to meet only the requirements of He-P 4043.05 and the following:

(a) The door to the room containing the RGD shall be posted “CAUTION – RADIATION AREA”, or “CAUTION – HIGH RADIATION AREA”, or “GRAVE DANGER – VERY HIGH RADIATION AREA”, as required by He-P 4022.12;

(b) All entrances into the shielded room shall be provided with interlocks. After an interlock has been interrupted, broken, or tripped, it shall be possible to cause x-rays to be produced again only from the control panel. Interlocks shall not be used to shut off the x-ray equipment except in an emergency or during testing;

(c) All entrances into the shielded room shall be provided with a conspicuously visible warning device, which need not be flashing or rotating but which operates only when radiation is being produced. The warning device shall be labeled in accordance with He-P 4043.05(b);

(d) The interior of the shielded room shall be provided with flashing or rotating warning lights that operate when, and only when, radiation is being produced. These lights shall be positioned so that they can be observed from any position or orientation within the room. The lights shall be posted indicating the meaning of the warning signal and instructions on what to do. The posting shall be legible, conspicuous, and accessible to view;

(e) An audible warning signal within the room shall be actuated for at least 10 seconds immediately prior to the first initiation of radiation after the closing of any opening that can admit personnel. The registrant shall post the meaning of the warning signal and instructions on what to do. The posting shall be legible, conspicuous, and accessible to view;

(f) If dose rates exceed the high radiation area limits, as defined in He-P 4003.01(bx), emergency shut-off switches shall be located within the high radiation areas so as to be accessible to individuals therein within 10 seconds. These switches and their mode of operation shall be identified by a conspicuously posted sign adjacent to the switch. The emergency shut-off switches shall include a manual reset that must be reset at the switch before x-rays can again be produced from the control panel. After an emergency shut-off switch has been activated, it shall be possible to produce x-rays again only from the control panel;

(g) The interlock system and the emergency shut-off system shall be separate electrical or mechanical systems, or both;

(h) A person within the room housing a RGD shall be able to egress at all times;

(i) After each exposure and before entry of any personnel, a survey shall be performed upon entry to the shielded room to determine that the RGD is no longer producing radiation;

(j) Personnel devices providing an audible signal when activated by radiation shall be acceptable for the survey requirement of He-P 4043.11(i) provided that:

(1) Proper operation of the audible detection device is checked daily and a record maintained of this check;

(2) The audible device is designed so as to clearly indicate entry into a 0.02 mSv (2 mrem) per hour or greater radiation field; and

(3) All personnel working with the RGD are provided with such a device;

(k) Stationary area monitors providing an audible signal when activated by radiation shall be acceptable for the survey requirement of He-P 4043.11(i) provided that:

(1) Proper operation of the stationary detection device is checked daily and a record maintained of this check;

(2) The stationary device is designed so as to clearly indicate entry into a 0.02 mSv (2 mrem) per hour or greater radiation field; and

(3) Stationary area monitors are calibrated annually to determine that the audible signal operates at a 0.02 mSv (2 mrem) per hour radiation field;

(l) All personnel associated with the x-ray equipment shall be provided with personnel monitoring devices that shall be calibrated for the x-ray energies being utilized. Records of personnel exposure shall be maintained;

(m) No registrant shall permit any individual to operate a RGD in a shielded room until such individual has received a copy of, instruction in, and demonstrated an understanding of, operating and emergency procedures for the unit and competence in its use. Records shall be maintained of all operator training;

(n) The equipment control panel shall be provided with a locking device to prevent unauthorized use. Such locking device shall, when locked, prevent the production of radiation by the equipment; and

(o) If a safety or warning device malfunctions, the control panel shall be locked in the “off” position. The control panel shall not be used, except as might be necessary for repair or replacement of the malfunctioning safety or warning device, until the safety or warning device is functioning properly.

Source. #14336, eff 8-8-25, EXPIRES: 8-8-35

He-P 4043.12 Bomb Detection RGDs. In addition to the general requirements in He-P 4043.05, not otherwise exempted under He-P 4043.04(a), the following requirements in this section shall apply to bomb detection radiation equipment:

(a) When not in use, each bomb detection radiation machine shall be locked to prevent unauthorized use;

(b) The registrant shall maintain for each bomb detection radiation machine a utilization log. This log shall record the description of the unit, the date removed from storage, the date returned to storage, the identity and signature of the person to whom the device is assigned, the dates of use, and the site(s) of use; and

(c) The registrant shall provide security to prevent entry by individuals from any point when the machine is energized during training.

Source. #14336, eff 8-8-25, EXPIRES: 8-8-35

He-P 4043.13 RGDs Used in Personnel Security Screening or Vehicle Screening for Public Protection.

(a) In addition to the general requirements in He-P 4043.05, the following requirements in this section apply. A person requesting DHHS/RHS approval for a RGD to be used in personnel security screening or vehicle screening with intended exposure of human occupants to the primary beam for public protection shall submit documentation to DHHS/RHS showing how the dose limits noted in the below paragraphs will be met.

(b) As part of the application, the applicant shall provide an evaluation of all known alternate methods that could achieve the goals of the security screening program, and why these methods will not be used in preference to the proposed approach utilizing ionizing radiation.

(c) RGDs used for non-healing arts personnel security screening of humans shall be evaluated every 12 months by a qualified expert for optimization of image quality and radiation dose.

(d) For general-use screening systems, where the system is used without regard to the number of individuals scanned or number of scans per individual in a year, an effective dose for a single complete screening shall be limited to 0.25 µSv (25 µrem).

(e) For limited-use screening systems, where equipment is capable of operation greater than 0.25 µSv (25 µrem) per screening, and is used with discretion, the effective dose per screening shall be less than or equal to 0.01 mSv (1 mrem).

(f) Individuals subject to repeat security screening at a single venue shall not receive an effective does greater than 0.25 mSv (25 mrem) in any one year at the registrant or licensee’s facility.

(g) When the procedures for operation of a mobile or fixed RGD used for security screening of vehicles includes knowingly exposing human occupants to the primary beam when screening vehicles, structures, or containers, the system shall be subject to the same requirements as general-use or limited-use systems as provided in He-P 4043.13(a)-(e).

(h) If the requirements in He-P 4043.13(c)-(e) cannot be met if vehicle occupants are knowingly exposed to the primary beam of a security screening system, then there shall be means to assure the occupied portion of the vehicle is outside of the scan area while the primary beam is emitted or procedures shall be established and implemented to assure that no occupants are present in the vehicle during screening.

(i) The effective dose to an individual for a single inadvertent exposure to the primary beam shall not exceed 5 mSv (500 mrem) and should not exceed 1 mSv (100 mrem). The reliability of the procedure used to assure that there are no occupants of a vehicle to be scanned shall be commensurate with the potential severity of an inadvertent exposure. If the 5 mSv (500 mrem) limit cannot be assured, a pre-screening with a mode or system which can meet the limits in He-P 4043.13(c)-(h). shall be used to verify there are no occupants in the vehicle being examined.

Source. #14336, eff 8-8-25, EXPIRES: 8-8-35

PART He-P 4044 RADIATION REQUIREMENTS FOR PARTICLE ACCELERATORS

He-P 4044.01 Purpose. He-P 4044 establishes requirements for the registration and the use of particle accelerators.

Source. #6827, eff 8-6-98; ss by #8692, INTERIM, eff 7-27-06, EXPIRES: 2-2-07; ss by #8808, eff 1-24-07; ss by #10804, eff 3-26-15; ss by #14302, eff 7-1-25, EXPIRES: 7-1-35

He-P 4044.02 Scope. The requirements of this part are in addition to and not in substitution for, requirements in other parts of these rules.

Source. #6827, eff 8-6-98; ss by #8692, INTERIM, eff 7-27-06, EXPIRES: 2-2-07; ss by #8808, eff 1-24-07; ss by #10804, eff 3-26-15 ; ss by #14302, eff 7-1-25, EXPIRES: 7-1-35

He-P 4044.03 Registration Requirements. No person shall receive, possess, use, transfer, own, or acquire a particle accelerator except as authorized in a registration issued pursuant to He-P 4044 and the general procedures for registration of particle accelerator facilities included in He-P 4040.

Source. #6827, eff 8-6-98; ss by #8692, INTERIM, eff 7-27-06, EXPIRES: 2-2-07; ss by #8808, eff 1-24-07; ss by #10804, eff 3-26-15; ss by #14302, eff 7-1-25, EXPIRES: 7-1-35

He-P 4044.04 General Requirements for the Issuance of a Registration for Particle Accelerators. In addition to the requirements of He-P 4040, a registration application for use of a particle accelerator shall be approved if DHHS/RHS determines that:

(a) The applicant is qualified by reason of training and experience to use the accelerator for the purpose requested in accordance with He-P 4044 and He-P 4019 through He-P 4022 in such a manner as to minimize danger to public health and safety or property;

(b) The applicant’s proposed or existing equipment, facilities, operating and emergency procedures are adequate to protect health and minimize danger to public health and safety or property;

(d) The applicant satisfies any applicable special requirement in section He-P 4044.05;

(e) The applicant has appointed a radiation safety officer;

(f) The applicant and the applicant’s staff have substantial experience in the use of particle accelerators and training sufficient for application for the intended uses;

(g) The applicant has established a radiation safety committee to approve, in advance, proposals for uses of particle accelerators, whenever deemed necessary by DHHS/RHS; and

(h) The applicant has an adequate training program for particle accelerator operators.

Source. #6827, eff 8-6-98; ss by #8692, INTERIM, eff 7-27-06, EXPIRES: 2-2-07; ss by #8808, eff 1-24-07; ss by #10804, eff 3-26-15; ss by #14302, eff 7-1-25, EXPIRES: 7-1-35

He-P 4044.05 Human Use of Particle Accelerators. In addition to the requirements set forth in He-P 4040, a registration for use of a particle accelerator in the healing arts may be issued if:

(a) The applicant has appointed a medical committee of at least 3 members to evaluate all proposals for research, diagnostic, and therapeutic use of a particle accelerator. Membership of the committee shall include physicians expert in internal medicine, hematology, therapeutic radiology, and a person experienced in depth dose calculations and protection against radiation;

(b) The individuals designated on the application as the users have substantial training and experience in deep therapy techniques or in the use of particle accelerators to treat humans; and

Source. #6827, eff 8-6-98; ss by #8692, INTERIM, eff 7-27-06, EXPIRES: 2-2-07; ss by #8808, eff 1-24-07; ss by #10804, eff 3-26-15; ss by #14302, eff 7-1-25, EXPIRES: 7-1-35

He-P 4044.06 Limitations.

(a) No registrant shall permit any person to act as a particle accelerator operator until such person:

(1) Has been instructed in radiation safety and demonstrates an understanding thereof;

(2) Has received copies of He-P 4019 through He-P 4022, and He-P 4044, and the registrant’s operating and emergency procedures, and has demonstrated understanding thereof; and

(3) Has demonstrated competence to use the particle accelerator, related equipment, and survey instruments which will be employed.

(b) Either the radiation safety committee or the radiation safety officer shall have the authority to terminate the operations at a particle accelerator facility if such action is deemed necessary to protect health and minimize danger to public health and safety or property.

Source. #6827, eff 8-6-98; ss by #8692, INTERIM, eff 7-27-06, EXPIRES: 2-2-07; ss by #8808, eff 1-24-07; ss by #10804, eff 3-26-15; ss by #14302, eff 7-1-25, EXPIRES: 7-1-35

He-P 4044.07 Shielding and Safety Design Requirements.

(a) A qualified expert, registered with DHHS/RHS, pursuant to He-P 4040.06, shall be consulted in the design of a particle accelerator installation and called upon to perform a radiation survey when the accelerator is first capable of producing radiation.

(b) Each particle accelerator installation shall be provided with such primary and secondary barriers as are as necessary to assure compliance with He-P 4020.05 and He-P 4020.13.

Source. #6827, eff 8-6-98; ss by #8692, INTERIM, eff 7-27-06, EXPIRES: 2-2-07; ss by #8808, eff 1-24-07; ss by #10804, eff 3-26-15; ss by #14302, eff 7-1-25, EXPIRES: 7-1-35

He-P 4044.08 Particle Accelerator Controls and Interlock Systems.

(a) Instrumentation readouts and controls on the particle accelerator control console shall be clearly identified and easily discernible.

(b) Each entrance into a target room or other high radiation area shall be provided with a safety interlock that shuts down the machine under conditions of barrier penetration.

(c) When an interlock system has been tripped, it shall only be possible to resume operation of the accelerator by manually resetting controls at the position where the interlock has been tripped, and lastly at the main control console.

(d) Each safety interlock shall be on a circuit which shall allow its operation independently of all other safety interlocks.

(e) All safety interlocks shall be designed so that any defect or component failure in the safety interlock system prevents operation of the accelerator.

(f) A scram button or other emergency power cutoff switch shall be located and easily identifiable in all high radiation areas. Such a cutoff switch shall include a manual reset so that the accelerator cannot be restarted from the accelerator control console without resetting the cutoff switch.

Source. #6827, eff 8-6-98; ss by #8692, INTERIM, eff 7-27-06, EXPIRES: 2-2-07; ss by #8808, eff 1-24-07; ss by #10804, eff 3-26-15; ss by #14302, eff 7-1-25, EXPIRES: 7-1-35

He-P 4044.09 Warning Devices.

(a) Each location designated as high radiation area, and each entrance to such location shall be equipped with easily observable flashing or rotating warning lights that operate when, and only when, radiation is being produced.

(b) Except in facilities designed for human exposure, each high radiation area shall have an audible warning device which shall be activated for 15 seconds prior to the possible creation of such high radiation area. Such warning device shall be clearly discernible in all high radiation areas.

(c) Barriers, temporary or otherwise, and pathways leading to high radiation areas shall be identified in accordance with He-P 4022.04 and He-P 4022.12(b).

Source. #6827, eff 8-6-98; ss by #8692, INTERIM, eff 7-27-06, EXPIRES: 2-2-07; ss by #8808, eff 1-24-07; ss by #10804, eff 3-26-15; ss by #14302, eff 7-1-25, EXPIRES: 7-1-35

He-P 4044.10 Operating Procedures.

(a) Particle accelerators, when not in operation, shall be secured to prevent unauthorized use.

(b) The safety interlock system shall not be used to turn off the accelerator beam except in an emergency.

(c) All safety and warning devices, including interlocks, shall be checked for proper operation at intervals not to exceed 3 months. Results of such tests shall be maintained at the accelerator facility for inspection by DHHS/RHS.

(d) Electrical circuit diagrams of the accelerator, and the associated safety interlock systems, shall be kept current and maintained for inspection by DHHS/RHS and shall be available to the operator at each accelerator facility.

(e) If, for any reason, it is necessary to intentionally bypass a safety interlock or interlocks, such action shall be:

(1) Authorized by the radiation safety committee and the radiation safety officer;

(2) Recorded in a permanent log and a notice posted at the accelerator control console; and

(3) Terminated as soon as possible.

(f) A copy of the current operating and the emergency procedures shall be maintained at the accelerator control panel.

Source. #6827, eff 8-6-98; ss by #8692, INTERIM, eff 7-27-06, EXPIRES: 2-2-07; ss by #8808, eff 1-24-07; ss by #10804, eff 3-26-15; ss by #14302, eff 7-1-25, EXPIRES: 7-1-35

He-P 4044.11 Radiation Monitoring Requirements. Each particle accelerator facility shall have available:

(a) Appropriate portable monitoring equipment which:

(1) Is operable;

(2) Has been calibrated for the appropriate radiations being produced at the facility;

(3) Has been tested daily for proper operation;

(4) Has been calibrated at intervals not to exceed one year;

(5) Has been calibrated after each servicing; and

(6) Has been calibrated after repair;

(b) A radiation protection survey, performed and documented by a qualified expert specifically registered with DHHS/RHS pursuant to He-P 4040.06, which documents changes in shielding, operation, equipment, or occupancy of adjacent areas;

(c) Continuous monitoring devices for all high radiation areas which are electrically independent of the accelerator control and safety interlock systems and are capable of providing a readout at the control panel;

(d) All area monitors shall be calibrated at intervals not to exceed one year and after each servicing and repair;

(e) Periodic surveys to determine the amount of airborne particulate radioactivity present in areas of airborne hazards if applicable;

(f) Periodic smear surveys to determine the degree of contamination in target and other pertinent areas if applicable;

(g) All area surveys shall be made in accordance with the written procedures established by a qualified expert, or the radiation safety officer of the particle accelerator facility; and

(h) Records of:

(1) Radiation protection surveys;

(2) Calibration results;

(3) Instrumentation tests; and

(4) Smear results.

Source. #6827, eff 8-6-98; ss by #8692, INTERIM, eff 7-27-06, EXPIRES: 2-2-07; ss by #8808, eff 1-24-07; ss by #10804, eff 3-26-15; ss by #10804, eff 3-26-15; ss by #14302, eff 7-1-25, EXPIRES: 7-1-35

He-P 4044.12 Ventilation Systems.

(a) Adequate ventilation shall be provided in areas where airborne radioactivity may be produced.

(b) A registrant, as required by He-P 4020.14, shall not vent, release, or otherwise discharge airborne radioactive material to an unrestricted area in excess of the limits specified in He-P 4090 - Table 4090.1, except as authorized pursuant to He-P 4020.14(c) or He-P 4023.02.

(c) Every reasonable effort shall be made to maintain releases of radioactive material to unrestricted areas, as far below the limits required in He-P 4044.12(b) as practicable.

Source. #6827, eff 8-6-98; ss by #8692, INTERIM, eff 7-27-06, EXPIRES: 2-2-07; ss by #8808, eff 1-24-07; ss by #10804, eff 3-26-15; ss by #14302, eff 7-1-25, EXPIRES: 7-1-35

PART He-P 4045 USE OF RADIATION MACHINES: ADMINISTRATIVE REQUIREMENTS

He-P 4045.01 Purpose. He-P 4045 establishes the administrative and operational requirements for users of radiation or MRI machines in the healing arts, veterinary medicine, and all non-medical security screening systems

Source. #6827, eff 8-6-98; ss by #8692, INTERIM, eff 7-27-06, EXPIRES: 2-2-07; ss by #8808, eff 1-24-07; ss by #10763, INTERIM, eff 1-23-15, EXPIRES: 7-22-15; ss by #10893, eff 7-21-15; ss by #12024, INTERIM, eff 10-28-16, EXPIRED: 4-26-17

New. #12215, eff 6-20-17

He-P 4045.02 General Requirements.

(a) The registrant shall assure that the requirements of He-P 4040 are met prior to the use of any radiation or MRI machine.

(b) The registrant shall be responsible for directing the operation of the radiation or MRI machine(s) under the registrant’s administrative control.

(c) The registrant or the registrant’s agent shall assure that the requirements of He-P 4045, in addition to all other applicable parts, are met in the operation of the radiation or MRI machine(s).

Source. #6827, eff 8-6-98; ss by #8692, INTERIM, eff 7-27-06, EXPIRES: 2-2-07; ss by #8808, eff 1-24-0707; ss by #10763, INTERIM, eff 1-23-15, EXPIRES: 7-22-15; ss by #10893, eff 7-21-15

He-P 4045.03 Administrative Controls.

(a) A radiation or MRI machine which does not meet the provisions of these rules shall not be operated for diagnostic or therapeutic purposes.

(b) Persons who operate radiation or MRI machines shall be instructed in the manufacturer’s safe operating procedures and be competent in the safe use of the equipment.

(c) All MRI machine operators shall be able to demonstrate competence in the operation of the machine as required by (b) above, including, at a minimum, competence in the following areas:

(1) Familiarity with equipment to include:

a. Identification of controls; and

b. Function of each control; and

(2) Emergency procedures including procedure termination.

(d) All diagnostic radiation machine operators shall be able to demonstrate competence in the operation of the machine as required by (b) above, including, at a minimum competence in the following areas:

(1) Familiarity with equipment to include:

a. Identification of controls;

b. Function of each control; and

c. Use of a technique chart;

(2) Radiation protection measures to include:

a. Collimation;

b. Filtration;

c. Lead equivalent material patient protection devices, if used;

d. Restriction of x-ray tube radiation to the image receptor;

e. Personnel protection; and

f. Grids;

(3) Film and film processing to include:

a. Film speed as related to patient exposure;

b. Film processing parameters; and

c. Quality assurance techniques;

(4) Emergency procedures to include termination of exposure in the event of automatic timing device failure;

(5) Proper use of personnel dosimetry;

(6) An understanding of the units of radiation and dose; and

(7) An understanding of these rules.

(e) Specific technique factors and protocols for any diagnostic radiation machine which cannot be programmed to select body part, projection, or patient size, shall be created to include protocols to identify the following:

(1) Patient’s body part and anatomical size, or body part thickness, or age for pediatric, versus technique factors to be utilized;

(2) Type and size of the image receptor;

(3) Type of grid, if any;

(4) Source to image receptor distance to be used, except in dental intraoral radiography;

(5) Type and location of placement of patient shielding used; and

(6) Technique factors kVp, mA, and time.

(f) The registrant of a facility shall:

(1) Establish written safety procedures for the safe operation of radiation or MRI machines;

(2) Make written safety procedures available to all operators of radiation or MRI machines;

(3) Write safety procedures for use of machines at the facility which shall include, but not be limited to:

a. Patient holding; and

b. Any restrictions in the operating techniques required for the safe operation of a particular system.

(g) The radiation or MRI machine operator shall be able to demonstrate familiarity with the written safety procedures required in (f) above.

(h) Only staff, other persons required to be in attendance, and patients who cannot be evacuated shall be in the room during the radiographic exposure.

(i) All persons in the room other than the patient being examined shall be positioned so that no part of the body will be struck by the useful beam and shall be protected from scatter radiation by either protective aprons or whole body protective barriers, of not less than 0.5 millimeter lead equivalent material.

(j) Patients who cannot be removed from the room shall be positioned so that the nearest portion of the body is at least 2 meters from the tube head or the image receptor, whichever is closer.

(k) Radiologists shall assess the need for gonad shielding for diagnostic imaging acquisition including requiring that gonad shielding of no less than 0.5 millimeter lead equivalent material be used:

(1) For patients who have not passed the reproductive age; and

(2) During radiographic procedures in which the gonads are in the useful beam, except for cases in which this would interfere with the diagnostic procedure.

(l) Persons shall not be exposed to the useful beam, except for healing arts purposes when such exposure has been authorized by a licensed practitioner of the healing arts.

(m) Deliberate exposure of a person shall be prohibited for the following purposes:

(1) Exposure of a person for training, demonstration, or other non-healing-arts purposes; and

(2) Exposure of a person for the purpose of healing arts screening except as authorized by He-P 4045.04.

(n) If a patient or image receptor must be provided with auxiliary support during a radiation exposure:

(1) Mechanical holding devices shall be used whenever possible;

(2) The written safety procedures, required by He-P 4045.03(f), shall indicate the requirements for selecting a human holder and the procedure the human holder shall follow;

(3) The human holder shall be instructed in personal radiation safety and protected as required by He-P 4045.03(f);

(4) No person shall be used routinely to hold image receptors or patients;

(5) In cases where the patient must hold the image receptor, except during intraoral examinations, any portion of the body other than the area of clinical interest struck by the useful beam shall be protected by not less than 0.5 millimeter lead equivalent material;

(6) Each facility shall have lead equivalent garments or barriers available in sufficient numbers to provide protection to all personnel who shall be involved with radiation machine operations and not otherwise shielded; and

(7) All protective apparel or barriers shall be clearly labeled with its lead equivalence.

(o) Procedures and auxiliary equipment designed to minimize patient and personnel exposure shall be utilized as follows:

(1) The speed of the screen and film combinations used shall be the fastest speed consistent with the diagnostic objective of the examinations;

(2) Film cassettes without intensifying screens shall not be used for any routine diagnostic radiological imaging, with the exception of veterinary radiography and standard film packets for intraoral use in dental radiography;

(3) The radiation exposure to the patient shall be the minimum exposure required to produce images of high diagnostic quality;

(4) Portable or mobile x-ray equipment shall be used only for examinations where it is impractical to transfer the patient(s) to a stationary x-ray system;

(5) X-ray systems other than fluoroscopic, dental, computed tomography, or veterinary systems shall not be utilized in procedures where the source to patient distance is less than 30 centimeters; and

(6) If grids are used between the patient and the image receptor, the grid shall:

a. Be positioned properly;

b. Centered to the central ray; and

c. If of the focused type, be of the proper focal distance for the SIDs being used.

(p) All persons who are associated with the operation of an x-ray system shall be subject to the requirements of He-P 4020 through He-P 4022 of these rules.

Source. #6827, eff 8-6-98; ss by #8692, INTERIM, eff 7-27-06, EXPIRES: 2-2-07; ss by #8808, eff 1-24-07; ss by #10763, INTERIM, eff 1-23-15, EXPIRES: 7-22-15; ss by #10893, eff 7-21-15; para (c) amd by #12024, INTERIM, eff 10-28-16, EXPIRED: 4-26-17; para (c) amd by #12215, eff 6-20-17; ss by #13410, eff 7-26-22

He-P 4045.04 Healing Arts Screening.

(a) Any person proposing to conduct a healing arts screening program shall be preapproved by DHHS/RHS, and shall submit the following information with the request for approval:

(1) Name, address, and telephone number of the applicant and, where applicable, the names, addresses, and telephone number(s) of agents within this State;

(2) A detailed description of the x-ray examinations proposed in the screening program, including;

a. Diseases or conditions subject to x-ray examinations;

b. A description of the population to be examined in the screening program;

c. Technique factors to be used;

d. A description of the diagnostic x-ray quality control program;

e. A description of procedures to advise persons screened and their practitioners of the results of the screenings;

f. A description of the procedures for the retention or disposition of the radiographs and other records pertaining to the x-ray examinations; and

g. An indication of the frequency of screening and the anticipated duration of the entire screening program;

(3) An evaluation of any known alternate methods not involving ionizing radiation which could achieve the goals of the screening program and reasons why these methods are not used instead of the x-ray examinations;

(4) An evaluation by a qualified expert of the x-ray system(s) to be used in the screening program which shall:

a. Show that such system(s) do satisfy all requirements of these rules; and

b. Include a measurement of patient exposures from the x-ray examinations to be performed;

(5) The qualifications of each person who will be operating the x-ray system(s), of those who will be supervising the operators of the x-ray system(s), the extent of supervision, and the method of work performance evaluation; and

(6) The name and address of the person who will interpret the radiograph(s).

(b) If any information submitted to DHHS/RHS becomes invalid or outdated, DHHS/RHS shall be notified within 15 days.

Source. #6827, eff 8-6-98; ss by #8692, INTERIM, eff 7-27-06, EXPIRES: 2-2-07; ss by #8808, eff 1-24-07; ss by #10763, INTERIM, eff 1-23-15, EXPIRES: 7-22-15; ss by #10893, eff 7-21-15

He-P 4045.05 Maintenance Record and Associated Information. The registrant shall maintain the following information for each x-ray system or MRI machine for inspection by DHHS/RHS until the registration requiring records is terminated:

(a) Model and serial numbers of all major components, and user’s manuals for those components;

(b) Records of shielding reviews and surveys, where applicable;

(d) A copy of all correspondence with DHHS/RHS regarding that x-ray system.

Source. #6827, eff 8-6-98; ss by #8692, INTERIM, eff 7-27-06, EXPIRES: 2-2-07; ss by #8808, eff 1-24-07; ss by #10763, INTERIM, eff 1-23-15, EXPIRES: 7-22-15; ss by #10893, eff 7-21-15

He-P 4045.06 X-Ray System Utilization Log.

(a) Each facility shall maintain or be able to generate electronically a record containing:

(1) The patient’s name;

(2) The type of examinations; and

(3) The dates the examinations were performed.

(b) When the patient or image receptor must be provided with human auxiliary support, the name of the human holder shall be recorded in the patient record for whom the support was provided, or cross-referenced to the patient record.

Source. #6827, eff 8-6-98; ss by #8692, INTERIM, eff 7-27-06, EXPIRES: 2-2-07; ss by #8808, eff 1-24-07; ss by #10763, INTERIM, eff 1-23-15, EXPIRES: 7-22-15; ss by #10893, eff 7-21-15

He-P 4045.07 X-Ray Film Processing Facilities and Practices.

(a) Each registrant using analog image receptors, such as film, shall have available suitable equipment for handling and processing radiographic film in accordance with the following provisions:

(1) For manually developed film:

a. Processing tanks shall be constructed of mechanically rigid, corrosion resistant material;

b. Developer solutions in the developing tanks shall be maintained at temperatures within the range of 60°F to 80°F (16°C to 27°C);

c. Film shall be developed in accordance with the time-temperature relationships recommended by the film manufacturer, or, in the absence of such recommendations, with the recommendations set forth in Table 4045.1;

d. Devices shall be utilized which will indicate the actual temperature of the developer solution; and

e. Devices shall be used to signal the passage of a preset time appropriate to the developing time required;

Table 4045.1 Manual Time-Temperature Chart

Developer Solution Temperature (Degrees) (C) (F)		Minimum Developing Time (Minutes)
26.7	80	2.0
26.1	79	2.0
25.6	78	2.5
25.0	77	2.5
24.4	76	3.0
23.9	75	3.0
23.3	74	3.5
22.8	73	3.5
22.2	72	4.0
21.7	71	4.0
21.1	70	4.5
20.6	69	4.5
20.0	68	5.0
19.4	67	5.5
18.9	66	5.5
18.3	65	6.0
17.8	64	6.5
17.2	63	7.0
16.7	62	8.0
16.1	61	8.5
15.6	60	9.5

(2) For automatic processors and other closed processing systems:

a. Films shall be developed in accordance with the time-temperature relationships recommended by the film manufacturer; or, in the absence of such recommendations, the film shall be developed using Table 4045.2; and

b. The specified developer solution temperature and immersion time shall be posted in the darkroom or on the automatic processor; and

Table 4045.2 Automatic Time-Temperature Chart

Developer Solution Temperature (C) (F)		Minimum Immersion Time⁽¹⁾ (Seconds)
35.5	96	19
35.0	95	20
34.5	94	21
34.0	93	22
33.5	92	23
33.0	91	24
32.0	90	25
31.5	89	26
31.0	88	27
30.5	87	28
30.0	86	29
29.5	85	30
⁽¹⁾ Immersion time only, no crossover time included.

(3) Processing deviations from the requirements of He-P 4045.07(a) shall be documented by the registrant in such manner that the requirements are shown to be met or exceeded.

(b) Each installation using an x-ray system and analog image receptor shall be subject to the following additional requirements:

(1) Pass boxes shall be constructed to exclude light from the darkroom when cassettes are placed in or removed from the boxes;

(2) Pass boxes shall incorporate adequate shielding from stray radiation to prevent exposure of undeveloped film;

(3) The darkroom shall be light tight;

(4) The darkroom shall use proper safe lighting such that any film type in use exposed in a cassette to x-rays sufficient to produce an optical density from 1 to 2 when processed shall not suffer an increase in density greater than 0.1 (0.05 for mammography) when exposed in the darkroom for 2 minutes with all safelights on;

(5) If used, daylight film handling boxes shall preclude fogging of the film;

(6) Darkrooms typically used by more than one person shall be provided with a method to prevent accidental entry while undeveloped films are being handled or processed;

(7) Film shall be stored in a cool, dry place and shall be protected from exposure to stray radiation;

(8) Film in open packages shall be stored in a light tight container;

(9) Film cassettes and intensifying screens shall be inspected periodically and shall be cleaned and replaced as necessary, but at least annually;

(10) Outdated x-ray film shall not be used for diagnostic radiographs, unless:

a. The film has been stored in accordance with the manufacturer’s recommendations; and

b. A sample of the film passes a sensitometric test for normal ranges of base plus fog and speed;

(11) Film developing solutions shall be prepared in accordance with the directions given by the manufacturer; and

(12) Film developing solutions shall be maintained in strength by replenishment or renewal so that full development is accomplished within the time specified by the manufacturer.

Source. #6827, eff 8-6-98; ss by #8692, INTERIM, eff 7-27-06, EXPIRES: 2-2-07; ss by #8808, eff 1-24-07; ss by #10763, INTERIM, eff 1-23-15, EXPIRES: 7-22-15; ss by #10893, eff 7-21-15

He-P 4045.08 Facilities Using Computed Radiography (CR) or Direct Digital Radiography (DDR). Unless other recommendations are made in writing by a qualified expert, each registrant using computed radiography (CR) or direct digital radiography (DDR) modes shall comply with the manufacturer’s or vendor’s recommendations with regard to:

(a) Exposure indicator values;

(b) CR cassette erasure frequency; and

(c) Image evaluation for artifacts, spatial resolution, contrast/noise, and exposure indicator constancy unless otherwise advised in writing by a qualified expert.

Source. #10893, eff 7-21-15

He-P 4045.09 Veterinarian Facilities – Administrative Requirements.

(a) All veterinarian facilities using radiation or MRI machines shall:

(1) Complete registration procedures as set forth in He-P 4040.04 or He-P 4040.07 for machines in storage;

(2) Complete a renewal of registration as set forth in He-P 4040.08; and

(3) Complete shielding evaluations as set forth in He-P 4040.03; and

(b) All veterinarian facilities shall comply with all other radiation or MRI machine administrative requirements as specified in He-P 4045, except for He-P 4045.04.

Source. #10893, eff 7-21-15

He-P 4045.10 Non-medical Security Screening System.

(a) All non-medical security screening systems shall be exempt from the requirements of He-P 4045.03(l) and (m).

(b) Radiation safety surveys shall be conducted on security screening systems upon installation and after any maintenance or incident that could have damaged the system that affects the radiation machine performance.

(c) All non-medical security screening systems shall follow suggested manufacturer maintenance procedures and operability checks.

(d) All maintenance and radiation survey records shall be maintained for review by DHHS/RHS during an inspection.

Source. #12024, INTERIM, eff 10-28-16, EXPIRED: 4-26-17

New. #12215, eff 6-20-17

PART He-P 4046 USE OF RADIATION MACHINES: GENERAL REQUIREMENTS FOR ALL DIAGNOSTIC AND VETERINARY X-RAY SYSTEMS

He-P 4046.01 General Requirements for All Diagnostic X-ray. In addition to the requirements of He-P 4040 through He-P 4045, all diagnostic x-ray systems shall meet the following requirements:

(a) The control panel containing the main power switch shall bear a warning label that shall be legible, accessible to view, and shall state:

“WARNING: THIS X-RAY UNIT MAY BE DANGEROUS TO PATIENT AND OPERATOR UNLESS SAFE EXPOSURE FACTORS AND OPERATING INSTRUCTIONS ARE OBSERVED”;

(b) For battery-powered x-ray systems, visual means shall be provided on the control panel to indicate whether the battery is in a state of charge adequate for proper operation;

(d) The radiation emitted by a component other than the diagnostic source assembly shall not exceed 2 milliroentgens in one hour at 5 centimeters from any accessible surface of the component when it is operated in an assembled x-ray system under any conditions for which it was designed;

(e) Compliance with the requirements of He-P 4046.01(f) shall be determined by measurements averaged over an area of 100 square centimeters with no linear dimension greater than 20 centimeters;

(f) The half-value layer of the useful beam for a given x-ray tube potential shall not be less than the values shown in Table 4046.1;

Table 4046.1 Tube Potential v. Minimum Half-Value Layer

Design Operating Range	Measured Potential	Dental Intraoral Manufactured After 12/1/1980	Dental Intraoral Manufactured on or Before 12/1/1980 (and all other x-ray systems manufactured before 6/10/2006)	All X-ray Systems except Dental Intraoral Manufactured on or after 6/10/2006.
(k Vp)	(kVp)	(Half-Value Layer mm Aluminum)	(Half-Value layer mm Aluminum)	Half-Value Layer mm Aluminum)
Below 51	30	N/A	0.3	0.3
	40	N/A	0.4	0.4
	50	1.5	0.5	0.5
51 to 70	51	1.5	1.2	1.3
	60	1.5	1.3	1.5
	70	1.5	1.5	1.8
Above 70	71	2.1	2.1	2.5
	80	2.3	2.3	2.9
	90	2.5	2.5	3.2
	100	2.7	2.7	3.6
	110	3.0	3.0	3.9
	120	3.2	3.2	4.3
	130	3.5	3.5	4.7
	140	3.8	3.8	5.0
	150	4.1	4.1	5.4

(g) For capacitor energy storage equipment, compliance with the requirements of He-P 4046.01(g) and He-P 4046.01(f) shall be determined with the system fully charged and a setting of 10 mAs for each exposure;

(h) The required minimum half-value layer of the useful beam shall include the filtration contributed by all materials which are permanently between the source and the patient;

(i) For x-ray systems which have variable kVp and variable filtration for the useful beam, a device shall link the kVp selector with the filter(s);

(j) Where 2 or more radiographic tubes are controlled by one exposure switch, the tube or tubes which have been selected shall be clearly indicated on the x-ray control panel and on or near the selected tube housing assembly prior to the exposure initiation;

(k) The tube housing assembly supports shall be adjusted such that the tube housing assembly will remain stable during an exposure unless tube housing movement is a designed function of the x-ray system;

(l) Technique factors to be used during an exposure shall be indicated before the exposure begins;

(m) If automatic exposure controls are used, the technique factors which are set prior to the exposure shall be indicated;

(n) Indication of technique factors shall be visible from the operator’s position except in the case of spot-films made by the fluoroscopist;

(o) Diagnostic x-ray systems and their associated components used on humans and certified pursuant to the “Performance Standards for Ionizing Radiation Emitting Products” (21 CFR Part 1020) shall be maintained in compliance with applicable requirements of that standard; and

(p) All position locking, holding, and centering devices on x-ray system components and systems shall function as intended.

Source. #6827, eff 8-6-98; ss by #8692, INTERIM, eff 7-27-06, EXPIRES: 2-2-07; ss by #8808, eff 1-24-07; ss by #10763, INTERIM, eff 1-23-15, EXPIRES: 7-22-15; ss by #10893, eff 7-21-15

He-P 4046.02 Fluoroscopic X-ray Systems – General Requirements.

(a) All fluoroscopic x-ray systems used shall be image intensified or equipped with direct digital receptors.

(b) The fluoroscopic imaging assembly shall be provided with a primary protective barrier which intercepts the entire cross-section of the useful beam at any SID.

(c) The x-ray tube used for fluoroscopy shall not produce x-rays unless the barrier is in position to intercept the entire useful beam.

(d) X-ray production in the fluoroscopic mode shall be controlled by a device which requires continuous pressure by the fluoroscopist for the entire time of any exposure.

(e) When recording serial fluoroscopic images, the fluoroscopist shall be able to terminate the x-ray exposure(s) at any time.

(f) A means may be provided to permit completion of any single exposure of the series in progress.

(g) Beam limiting devices manufactured after May 22, 1979, and incorporated in equipment with a variable SID or a visible area of greater than 300 square centimeters shall provide stepless adjustment of the x-ray field.

(h) All equipment with a fixed SID and a visible area of 300 square centimeters or less shall be provided with:

(1) Stepless adjustment of the x-ray field; or

(2) With means to further limit the x-ray field size at the plane of the image receptor to 125 square centimeters.

(i) If provided, stepless adjustment shall, permit continuous field size adjustments down to a minimum field size no greater than 5 centimeters in either length or diameter at maximum SID.

(j) For rectangular x-ray fields used with circular image receptors, the error in alignment shall be determined along the length and width dimensions of the x-ray field which pass through the center of the visible area of the image receptor.

(k) Fluoroscopic spot-film devices shall meet the following requirements:

(1) Means shall be provided between the source and the patient for adjustment of the x-ray field size in the plane of the image receptor to the size of that portion of the image which has been selected on the spot-film selector;

(2) The adjustment required in He-P 4046.02 (1)(1) shall be automatically accomplished except when the x-ray field size in the plane of the image receptor is smaller than that of the selected portion of the image receptor;

(3) It shall be possible to adjust the x-ray field size in the plane of the image receptor to a size smaller than the selected portion of the image receptor;

(4) The minimum field size at the maximum SID shall be no larger than 5 centimeters in either length or diameter; and

(5) The center of the x-ray field in the plane of the image receptor shall be aligned with the center of the selected portion of the image receptor to not more than 2 percent of the SID.

(l) If means exist to override any of the automatic x-ray field size adjustments required in He-P 4046.02(g) through (l), that means:

(1) Shall be designed for use only in the event of system failure;

(2) Shall incorporate a signal visible at the fluoroscopist's position which will indicate whenever the automatic field size adjustment is overridden; and

(3) Shall be clearly and durably labeled:

“FOR X-RAY FIELD LIMITATION SYSTEM FAILURE”.

Source. #6827, eff 8-6-98; ss by #8692, INTERIM, eff 7-27-06, EXPIRES: 2-2-07; ss by #8808, eff 1-24-07; ss by #10763, INTERIM, eff 1-23-15, EXPIRES: 7-22-15; ss by #10893, eff 7-21-15

He-P 4046.03 Fluoroscopic X-ray Systems – Exposure Rate Limits.

(a) Fluoroscopic equipment manufactured on or before May 19, 1995 provided with manual mode only, shall not be operable at any combination of tube potential and current which will result in an exposure rate in excess of 5 roentgens per minute (i.e. air kerma rate in (AKR) excess of 44 mGy per minute) at the point where the center of the useful beam enters the patient except as follows:

(1) During recording of fluoroscopic images; or

(2) When an optional high level control is provided, in which case the limit shall be 10 roentgens per minute (i.e. AKR 88 mGy per minute).

(b) Fluoroscopic equipment manufactured on or before May 19, 1995 provided with automatic exposure rate control with or without manual mode shall not be operable at any combination of tube potential and current which will result in an exposure rate in excess of 10 roentgens per minute (i.e. AKR in excess of 88 mGy per minute) at that point where the center of the useful beam enters the patient, except during recording of fluoroscopic images.

(c) Fluoroscopic equipment manufactured after May 19, 1995 provided with manual mode only, shall not be operable at any combination of tube potential and current which will result in an exposure rate in excess of 5 roentgens per minute (i.e. AKR in excess of 44 mGy per minute) at the point where the center of the useful beam enters the patient.

(d) Fluoroscopic equipment manufactured after May 19, 1995 provided with automatic exposure rate control with or without manual mode shall not be operable at any combination of tube potential and current which will result in an exposure rate in excess of 10 roentgens per minute (i.e. AKR in excess of 88 mGy per minute) at that point where the center of the useful beam enters the patient, except when an optional high level control which was an option at the time of purchase is provided and activated, in which case the limit shall be 20 roentgens per minute (i.e. AKR 176 mGy per minute).

(e) The exposure rate limits expressed in He-P 4046.04(c) and (d) shall not apply to:

(1) Fluoroscopic equipment manufactured after May 19, 1995 but before June 10, 2006 when recording images with film or video camera with the tube in pulsed mode; and

(2) Fluoroscopic equipment manufactured after June 10, 2006 when recording images from the Image Intensifier for the user after exposure termination.

(f) If a high level control is provided, it shall:

(1) Have a separate means of activation;

(2) Be operable only when continuous manual activation is provided by the operator; and

(3) Provide a continuous signal audible to the fluoroscopist when in use.

(g) Any fluoroscopic equipment manufactured after May 19, 1995 which can produce an exposure rate in excess of 5 roentgens per minute (i.e. AKR in excess of 44 mGy per minute) shall be equipped with an automatic exposure rate control.

(h) Compliance with He-P 4046.03 shall be determined as follows:

(1) If the source is below the x-ray table, the exposure rate shall be measured one centimeter above the tabletop or cradle;

(2) If the source is above the x-ray table, the exposure rate shall be measured at 30 centimeters above the tabletop with the end of the beam-limiting device or spacer positioned as closely as possible to the point of measurement;

(3) For a C-arm/O-arm type of fluoroscope with fixed SID, the exposure rate shall be measured 30 centimeters from the input surface of the fluoroscopic imaging assembly, provided that the end of the beam-limiting device or spacer is no closer than 30 centimeters from the input surface of the fluoroscopic imaging assembly;

(4) In a C-arm type fluoroscope having an SID less than 45 centimeters, the AKR shall be measured at the minimum SSD;

(5) For a dedicated lateral type fluoroscope, the exposure rate shall be measured at a point 15 centimeters from the centerline of the x-ray table and in the direction of the x-ray source with the end of the beam limiting device or spacer positioned as closely as possible to the point of measurement. If the tabletop, required in He-P 4046.04(g)(4) is movable, the table shall be positioned as closely as possible to the lateral x-ray source, with the end of the beam-limiting device or spacer no closer than 15 centimeters to the centerline of the x-ray table; and

(6) For a special procedures type C-arm fluoroscope (angiography, interventional fluoro) with variable SID, the exposure rate shall be measured at the patient support located 30 cm from the image intensifier at minimum SID.

(i) Periodic measurement of entrance exposure rate shall be performed by a qualified expert for both typical and maximum values as follows:

(1) Such measurements shall be made annually or after any maintenance of the system which might affect the exposure rate;

(2) Results of these measurements shall be posted in the vicinity of the control panel to allow the fluoroscopist ready access to them while using the fluoroscope;

(3) Results of the measurements shall be posted in the record required in He-P 4045.05(c);

(4) The measurement results shall be stated in roentgens per minute and include the technique factors used in determining such results;

(5) The name of the person performing the measurements and the date the measurements were performed shall be included in the results;

(6) Conditions of periodic measurement of typical entrance exposure rate are as follows:

a. The measurement shall be made under the conditions that satisfy the requirements of He-P 4046.03(h);

b. The kVp, mA, and/or other selectable parameters shall be adjusted to those typical of clinical use on a 23 cm thick abdomen; and

c. Any x-ray system with automatic exposure rate control shall have sufficient attenuating material placed in the useful beam to produce kVp, mA, and other selectable parameters to satisfy the conditions of He-P 4046.04 (i)(6)b; and

(7) Conditions of periodic measurement of maximum entrance exposure rate are as follows:

a. The measurement shall be made under the conditions that satisfy the requirements of He-P 4046.04(h);

b. The kVp, mA, and other selectable parameters shall be adjusted to those settings which give the maximum entrance exposure rate; and

c. Any x-ray system(s) that incorporates automatic exposure rate control shall have sufficient attenuative material placed in the useful beam to produce the maximum entrance exposure rate of the system.

He-P 4046.04 Fluoroscopic X-ray Systems – Barrier Transmitted Radiation Rate Limits.

(a) The exposure rate due to transmission through the primary protective barrier with the attenuation block in the useful beam, combined with radiation from the image intensifier, if provided, shall not exceed 2 milliroentgens per hour at 10 centimeters from any accessible surface of the fluoroscopic imaging assembly beyond the plane of the image receptor per roentgen per minute of entrance exposure rate.

(b) The exposure rate due to transmission through the primary protective barrier combined with radiation from the image intensifier shall be determined by measurements averaged over an area of 100 square centimeters.

(c) If the source is below the tabletop, measurements shall be made with the input surface of the fluoroscopic imaging assembly positioned 30 centimeters above the tabletop.

(d) If the source is above the tabletop and the SID is variable, the measurement shall be made with the end of the beam-limiting device or spacer as close to the tabletop as it can be placed, but no closer than 30 centimeters.

(e) Movable grids and compression devices shall be removed from the useful beam during the measurement.

He-P 4046.05 Fluoroscopic X-Ray Systems – Additional Requirements.

(a) During fluoroscopy and cine-fluorography the kV and the mA shall be continuously indicated.

(b) The source to skin distance (SSD) shall not be less than:

(1) 38 centimeters on stationary fluoroscopic systems manufactured on or after August 1, 1974;

(2) 35.5 centimeters on stationary fluoroscopic systems manufactured prior to August 1, 1974;

(3) 30 centimeters on all mobile fluoroscopes; or

(4) 20 centimeters for all mobile fluoroscopes manufactured before June 10, 2006 when used for specific surgical applications;

(5) 19 centimeters for all stationary mobile C-arm fluoroscopes manufactured on or after June 10, 2006 with a source to image distance (SID) less than 45 centimeters and labeled for extremity use only; or

(6) 10 centimeters for all stationary mobile C-arm fluoroscopes manufactured on or after June 10, 2006 with a source to image distance (SID) less than 45 centimeters and not labeled for extremity use only.

(1) Be provided to reset the cumulative on-time of the fluoroscopic x-ray tube;

(2) Not exceed 5 minutes without resetting for the maximum cumulative time of the timing device;

(3) Indicate the completion of any preset cumulative on-time with a signal audible to the fluoroscopist; and

(4) Continue to have such signal sound while x-rays are produced until the timing device is reset.

(d) With the exception of C-arm fluoroscopes, fluoroscopic table designs in combination with procedures shall be such that no unprotected part of any staff or ancillary person’s body is exposed to unattenuated scattered radiation generated under the table.

(e) The attenuation required by He-P 4046. 05(d) shall not be less than 0.25 millimeter lead equivalent.

(f) With the exception of C-arm fluoroscopes, equipment configuration when combined with procedures shall be such that no portion of any staff or ancillary person’s body, except the extremities, is exposed to the unattenuated scattered radiation generated above the tabletop unless either:

(1) That person is at least 120 centimeters from the center of the useful beam; or

(2) The radiation has passed through not less than 0.25 millimeter lead equivalent material including, but not limited to drapes, bucky-slot cover panel, or self-supporting curtains, in addition to any lead equivalency provided by the protective apron.

(g) Upon receipt of a written request, DHHS/RHS shall grant exemptions to He-P 4046.05(f) where a required sterile field will not permit the use of normal protective barriers for any fluoroscopic procedures.

(h) Fluoroscopic systems equipped with spot-film mode shall meet the exposure reproducibility requirements of He-P 4046 when operating in the spot-film mode.

(i) Radiation therapy simulation systems shall be exempt from:

(1) All the requirements of He-P 4046.03;

(2) The requirements of He-P 4046.02 and He-P 4046.04 provided that no person other than the patient is in the x-ray room when the system is producing x-rays; and

(3) The requirements of He-P 4046.05(c) if such systems are capable of indicating cumulative exposure times for individual patients.

(j) Procedures for radiation therapy simulation systems shall require that the timer be reset between treatments.

(k) All fluoroscopic equipment displays manufactured on or after June 10, 2006 shall:

(1) Be equipped with means to display the last image hold (LIH) following exposure termination; and

(2) Display the air kerma rate and cumulative air kerma at the fluoroscopist’s working position.

He-P 4046.06 Radiographic Systems Other Than Fluoroscopic, Dental Intraoral, or Computed Tomography X-ray Systems.

(a) The useful beam of all radiographic systems except mammographic, fluoroscopic, dental intraoral or computed tomography systems shall be capable of being limited to the area of clinical interest.

(b) General purpose stationary and mobile x-ray systems, including veterinary systems, other than portable, shall meet the following:

(1) Only x-ray systems provided with means for independent stepless adjustment of at least two dimensions of the x-ray field shall be used;

(2) A method shall be provided for visually defining the perimeter of x-ray field;

(3) The total misalignment of the edges of the visually defined field compared to the respective edges of the x-ray field shall not exceed 2 percent of the distance from the source to the center of the visually defined field when it is perpendicular to the axis of the x-ray beam;

(4) DHHS/RHS may grant non-certified x-ray systems an exemption from the requirements of He-P 4046.06(b)(1), (2), and (3) provided the registrant makes a written application for such exemption, and in that application:

a. Demonstrates it is impractical to comply with He-P 4046. 06(b); and

b. Describes how the purpose of He-P 4046. 06(b) will be met by other methods;

(5) In addition to the requirements of He-P 4046.06(b)(1)-(4), stationary general purpose x-ray systems shall meet the following requirements:

a. Methods shall be provided to indicate when the axis of the x-ray beam is perpendicular to the plane of the image receptor, to align the center of the x-ray field to the center of the image receptor to not more than 2 percent of the SID;

b. The beam-limiting device shall indicate numerically the field size in the plane of the image receptor to which it is adjusted;

c. Indication of field size dimensions and SIDs shall be specified in inches and centimeters; and

d. X-ray field dimensions in the plane of the image receptor shall correspond to those indicated by the beam-limiting device to not more than 2 percent of the SID when the beam axis is perpendicular to the plane of the image receptor; and

(6) X-ray systems designed for only one image receptor size at a fixed SID shall:

a. Be provided with means to limit the field at the plane of the image receptor to dimensions no greater than those of the image receptor; and

b. Align the center of the x-ray field with the center of the image receptor to not more than 2 percent of the SID.

(c) X-ray systems other than those described in He-P 4046.06, and all veterinary x-ray systems shall meet the following when the axis of the x-ray beam is perpendicular to the plane of the image receptor:

(1) Means shall be provided to limit the x-ray field within, and perpendicular to the plane of the image receptor such that the field does not exceed each dimension of the image receptor by more than 2 percent of the SID; and

(2) Means shall be provided to align the center of the x-ray field with the center of the image receptor to not more than 2 percent of the SID.

(d) Means shall be provided to initiate the radiation exposure only by a deliberate action on the part of the operator.

(e) An exposure shall not be possible when the timer is set to a “zero” or “off” position.

(f) Means shall be provided for visual indication observable at or from the operator’s protected position whenever x-rays are produced.

(g) A signal audible to the operator shall indicate that the exposure has terminated.

(h) Means shall be provided to terminate the exposure at:

(1) A preset time interval or number of pulses;

(2) A preset product of current and time; or

(3) A preset radiation exposure to the image receptor.

(i) Except for dental panoramic systems, termination of an exposure shall cause automatic resetting of the timer to its initial setting or to “zero.”

(j) An x-ray control shall be incorporated into each x-ray system such that an exposure can be terminated manually, by the operator, at any time except for:

(1) Exposures of one-half second or less; or

(2) Serial radiography when means shall be provided to permit completion of any single exposure of the series in process.

(k) When an automatic exposure control is provided:

(1) The control panel shall indicate when this mode of operation is selected;

(2) If the x-ray tube potential is equal to or greater than 51 kVp, the minimum exposure time for pulsed operation shall be equal to 2 pulses;

(3) The minimum exposure time for all equipment other than specified in He-P 4047. 06(k)(2) shall be no greater than one-sixtieth (1/60) second, or a time interval required to deliver 5 mAs, whichever is greater; and

(4) Manual exposure resetting shall be required before further timed exposures can be made.

(l) For systems having independent selection of exposure time settings, the average ratios (X_i) of exposure to the indicated timer setting, in units of milliroentgens per second (mR/s), obtained at any two clinically used timer settings shall not differ by more than 0.10 times their sum. This is written as:

where X₁ and X₂ are the average mR/s values.

(m) The x-ray exposure control shall be so placed that the operator can view the patient while making any exposure.

(n) Stationary x-ray systems, except veterinary systems, shall be required to have the x-ray control permanently mounted in a protected area that by virtue of shielding or distance or both shall protect the operator during the entire exposure from radiation scatter and is sufficient to comply with the occupational dose limits required by He-P 4020.05.

(o) Mobile and portable x-ray systems, except veterinary systems shall meet the requirements of He-P 4046.06(n) if used continuously for greater than one week in the same location, and shall be provided with means to limit the source to skin distance equal to, or greater than 30 centimeters.

(p) All stationary, mobile or portable x-ray systems used for veterinary work shall be provided:

(1) With a 2 meter (6.5 feet) high protective barrier for operator protection during exposures or

(2) With means to allow the operator to be at least 2.7 meters (9 feet) from the tube housing assembly during the exposure.

(q) All mobile or portable radiographic systems, except veterinary systems, shall be provided with means to limit the source-to-skin distance to equal to or greater than 30 centimeters.

(r) When all technique factors are held constant, including control panel selections associated with automatic exposure control systems, the coefficient of variation of exposure for both manual and automatic exposure control systems shall not exceed 0.05.

(s) Radiation emitted from the x-ray tube when the system is fully charged and the exposure switch or timer is not activated shall not exceed a rate of 2 milliroentgens per hour (mR/hr) at 5 centimeters from any accessible surface of the diagnostic source assembly, with the beam-limiting device fully open.

(t) Deviation of measured technique factors shall:

(1) Not exceed 10 percent of the indicated kVP value unless allowed by the manufacturer’s written specification; and

(2) Not exceed 20 percent of the exposure time, which is either indicated or which can be inferred from known mA or mAs values, unless allowed by the manufacturer’s written specification.

(u) When equipment having independent selection of x-ray tube current (mA), or a combined x-ray tube current exposure time product (mAs), is operated between 40 percent and 100 percent of the maximum rated kVp, the absolute value of the difference in the ratios (X_i) of exposure to the indicated milliampere-seconds product mR/mAs obtained at any two consecutive tube current settings shall not differ by more than 0.10 times their sum:

where the values of X₁ and X₂ are the average values which are obtained at each of two consecutive tube current settings, or are obtained at two settings differing by no more than a factor of 2 where the tube current selection is continuous.

He-P 4046.07 Certified Diagnostic Systems Only. Diagnostic x-ray systems incorporating one or more certified component(s) shall be required to comply with the following:

(a) For beam limitation for stationary and mobile general purpose x-ray systems, the following shall be provided:

(1) A means of stepless adjustment of the size of the x-ray field;

(2) A minimum field size at an SID of 100 centimeters equal to or less than 5 centimeters by 5 centimeters;

(3) A light localizer, if used to define the x-ray field, shall provide an average illumination, based upon measurements made in the approximate center of each quadrant of the light field, of not less than 160 lux or 15 foot-candles at 100 centimeters or the maximum SID, whichever is less; and

(4) Radiation therapy simulation systems manufactured on and after May 27, 1980, are exempt from the requirement of He-P 4046.07(a)(3);

(b) For beam limitation on stationary general purpose x-ray systems equipped with positive beam limitation (PBL), the following requirements shall be met:

(1) The PBL system shall be capable of operation, at the discretion of the operator, such that the size of the field may be made smaller than the size of the image receptor through stepless adjustment of the field size;

(2) The minimum field size at an SID of 100 centimeters shall be equal to or less than 5 centimeters by 5 centimeters; and

(3) The PBL system shall function such that any change of image receptor size or SID shall cause the automatic return to PBL;

(c) Beam limitation for portable x-ray systems shall meet the beam limitation requirements of He‑P 4046.07(a) or (b) as applicable;

(d) A tube stand or other mechanical support shall be used for portable x-ray systems, so that the x-ray tube housing assembly need not be hand-held during exposures; and

(e) Hand-held dental intraoral x-ray systems shall not be subject to the requirements of He-P 4046.07(d).

He-P 4046.08 Dental Intraoral Radiographic Systems. In addition to the provisions of He-P 4045 and He-P 4046.01, the requirements of this section shall apply to x-ray systems used for dental radiography:

(a) X-ray systems designed for use with an intraoral image receptor shall be provided with means to limit SSD, to not less than:

(1) 18 centimeters if operable above 50 kVp; or

(2) 10 centimeters if operable at 50 kVp only;

(b) X-ray systems designed for use with an intraoral image receptor shall be provided with means to limit the x-ray beam such that the beam at the minimum SSD shall be containable in a circle having a diameter of no more than 7 centimeters;

(1) No radiation exposure shall occur unless initiated by the operator;

(2) It shall not be possible to make an exposure when the timer is set to a “zero” or “off” position is provided;

(3) A visual indication of x-ray production shall be observable by the operator;

(4) An audible signal to the operator shall indicate that the exposure has terminated;

(5) Means shall be provided to terminate the exposure at a preset time interval, preset product of current and time, a preset number of pulses, or a preset radiation exposure to the image receptor;

(6) Exposures can be terminated by the operator at any time, except for exposures of 0.5 second or less;

(7) Termination of an exposure shall cause automatic resetting of the timer to its initial setting or to “zero”;

(8) Stationary intraoral systems shall be required to have the x-ray exposure control permanently mounted in a protected area, so that the operator is required to remain in that protected area during the entire exposure;

(9) Mobile intraoral systems which are:

a. Used for greater than one week in the same location, i.e., a room or suite, shall meet the requirements of He-P 4046.08(c)(8); or

b. Used for less than one week in the same location shall be provided with either a protective barrier at least 2 meters (6.5 feet) high for operator protection, or means to allow the operator to be at least 2.7 meters (9 feet) from the tube housing assembly while making exposures; and

(10) Hand-held dental intraoral x-ray machines shall not be subject to the requirements of He-P 4046.08(c)(8) and He-P 4046.08(c)(9);

(d) When the equipment is operated on an adequate power supply as specified by the manufacturer, the estimated coefficient of variation of radiation exposures shall be no greater than 0.05, for any specific combination of selected technique factors;

(e) Deviation of technique factors from indicated values for kVp and exposure time shall not exceed the limits specified for that system by its manufacturer or in the absence of manufacturer’s specifications the deviation shall not exceed 10 percent of the indicated value for kVp and 20 percent for time;

(f) Dental x-ray systems with a nominal fixed kVp of less than 50 kVp shall not be used to make diagnostic dental radiographs of humans; and

(g) The following administrative controls shall be in place:

(1) Patient and image receptor holding devices shall be used when the techniques permit;

(2) Neither the tube housing nor any position indicating device (PID) such as a Rinn kit shall be hand-held during an exposure; and

(3) Dental fluoroscopy without image intensification shall not be used.

He-P 4046.09 Hand-held Dental Intraoral Machines. The following requirements shall apply to the use of hand-held dental intraoral machines:

(a) For all uses:

(1) The registrant shall follow all applicable requirements set forth in the New Hampshire Rules for the Control of Radiation (NHRCR), as well as all manufacturers’s requirements;

(2) The machine shall be used only for dental diagnostic imaging;

(3) The protective shielding shall not be removed or modified;

(4) The registrant shall provide a copy of their operating, safety and security procedures to operators to prevent unauthorized or improper use;

(5) The registrant shall prepare a quality assurance plan, with an emphasis on ensuring limited retaking of radiographs;

(6) Operators of hand-held dental intraoral machines shall be specifically trained to operate such equipment, and the registrant shall provide proof of training for all operators;

(7) When operating a hand-held dental intraoral machine, operators shall wear a lead apron as well as an extremity dosimeter on the hand closest to the protective shielding;

(8) A hand-held dental intraoral machine shall be held without any motion during a patient examination. A tube stand or Rinn kit may be utilized to immobilize a hand-held dental intraoral radiographic unit during patient examination;

(9) Operators of hand-held dental intraoral machines shall provide a secondary protective barrier for patients; and

(10) The operator shall ensure that there are no bystanders within a radius of at least 6 feet (2 meters), from the patient being examined with a hand-held intraoral machine.

(b) Additional requirements for operatories in permanent facilities:

(1) Hand-held dental intraoral machines shall be used for patient examinations only in dental operatories that meet the structural shielding requirements specified by DHHS/RHS or by a qualified expert;

(2) Hand-held dental intraoral machines shall not be used for patient examinations in hallways and waiting rooms; and

(3) For battery-powered units, visual means shall be provided on the control panel to indicate whether the battery is in a state of charge adequate for proper operation.

Source. #6827, eff 8-6-98; ss by #8692, INTERIM, eff 7-27-06, EXPIRES: 2-2-07; ss by #8808, eff 1-24-07; ss by #10763, INTERIM, eff 1-23-15, EXPIRES: 7-22-15; ss by #10893, eff 7-21-15

He-P 4046.10 Dental Cone-Beam CT (CBCT). Dental systems shall be:

(a) Certified by the manufacturer pursuant to the Medical Device Act and Subchapter C-Electronic Product Radiation Control (EPRC) of Chapter V of the Federal Food, Drug and Cosmetic Act;

(b) Registered in accordance with He-P 4040;

(d) Operated by persons who have been specifically trained by the manufacturer.

Source. #6827, eff 8-6-98; ss byD, INTERIM, eff 7-27-06, EXPIRES: 2-2-07; ss by #8808, eff 1-24-07; ss by #10763, INTERIM, eff 1-23-15, EXPIRES: 7-22-15; ss by #10893, eff 7-21-15

He-P 4046.11 Computed Tomography X-ray System Requirements.

(a) Automatic termination of x-ray exposures in the event of equipment failure shall occur either by de-energizing the x-ray source or shuttering the x-ray beam.

(b) Termination as required in He-P 4046.11(a) above shall occur within an interval that limits the total scan time to no more than 110 percent of its preset value.

(c) Premature termination of the x-ray exposure by the operator shall require resetting of the CT conditions of operation prior to initiation of another scan.

(d) A visible signal shall indicate when the x-ray exposure has been terminated.

(e) The operator shall be able to terminate the x-ray exposure at any time during a scan of greater than one-half second duration.

(f) For any single tomogram system, means shall be provided to permit visual determination of the tomographic plane or a reference plane offset from the tomographic plane.

(g) For any multiple tomogram system, means shall be provided to permit visual determination of the location of a reference plane.

(h) If a device using a light source is used to satisfy the requirements of He-P 4046.11(f) or (g) above, the light source shall provide illumination levels sufficient to permit visual determination of the location of the tomographic plane or reference plane under ambient light conditions of up to 500 lux.

(i) The CT x-ray control and gantry shall provide visual indication whenever x-rays are produced and, if applicable, whether the shutter is open or closed.

(j) Each emergency button or switch shall be clearly labeled as to its function.

(k) The CT conditions of operation to be used during a scan or a scan sequence shall be indicated prior to the initiation of a scan or a scan sequence.

(l) Indication of CT conditions of operation shall be visible from any position from which scan initiation is possible.

(m) The angular position where the maximum surface CTDI occurs shall be identified to allow for reproducible positioning of a CT dosimetry phantom.

(n) Additional requirements applicable to CT X-ray systems containing a gantry manufactured after September 3, 1985 shall be as follows:

(1) The total error in the indicated location of the tomographic plane or reference plane shall not exceed 5 millimeters;

(2) If the x-ray production period is less than one-half second, the indication of x-ray production shall be actuated for at least one-half second;

(3) Indicators at or near the gantry shall be discernible from any point external to the patient opening;

(4) The deviation of indicated scan increment versus actual increment shall not exceed plus or minus one millimeter with any mass from 0 to 100 kilograms resting on the support device; and

(5) The patient support device shall be incremented from a typical starting position to the maximum incremented distance or 30 centimeters, whichever is less, and then returned to the starting position. Measurement of actual versus indicated scan increment may be taken anywhere along the incremented distance.

He-P 4046.12 Computed Tomography X-ray Systems – Facility Design Requirements.

(a) Provision shall be made for 2-way aural communication between the patient and the operator at the control panel.

(b) Windows, mirrors, closed-circuit television, or an equivalent shall be provided to permit continuous observation of the patient during irradiation and shall be so located that the operator can observe the patient from the control panel.

(c) When the primary viewing system is by electronic means, an alternate viewing system shall be available for use in the event of failure of the primary viewing system.

He-P 4046.13 Computed Tomography X-ray Systems – Surveys, Calibrations, Spot Checks, and Operating Procedures.

(a) All CT x-ray systems shall have a survey made by or under the direction of a qualified expert.

(b) The registrant shall obtain a written report of the survey from the qualified expert, and a copy of the report shall be made available to DHHS/RHS upon request.

(c) The calibration of the radiation output of the CT x-ray system shall be performed by or under the direction of a qualified expert who is physically present at the facility during such calibration.

(d) The calibration of a CT x-ray system shall be performed at intervals specified by a qualified expert and after any change or replacement of components which, in the opinion of the qualified expert, could cause a change in the radiation output.

(e) The calibration of the radiation output of a CT x-ray system shall be performed with a calibrated dosimetry system which is traceable to a national standard and has been calibrated within the preceding 2 years.

(f) CT dosimetry phantom(s) shall meet the following specifications and conditions of use shall be used in determining the radiation output of a CT X-ray system:

(1) CT dosimetry phantom(s) shall be right circular cylinders of polymethyl methacrylate of density 1.19 plus or minus 0.01 grams per cubic centimeter;

(2) The phantom(s) shall be at least 14 centimeters in length and shall have diameters of 32.0 centimeters for testing CT x-ray systems designed to image any section of the body and 16.0 centimeters for systems designed to image the head or for whole body scanners operated in the head scanning mode;

(3) CT dosimetry phantom(s) shall provide means for the placement of a dosimeter(s) along the axis of rotation and along a line parallel to the axis of rotation 1.0 centimeter from the outer surface and within the phantom; and

(4) All dose measurements shall be performed with the CT dosimetry phantom placed on the patient couch or support device without additional attenuation materials present.

(g) The calibration shall be required for each type of head, body, or whole-body scan performed at the facility.

(h) Calibration shall meet the following requirements:

(1) The dose profile along the center axis of the CT dosimetry phantom for the minimum, maximum, and midrange values of the nominal tomographic section thickness used by the registrant shall be measurable;

(2) Where less than 3 nominal tomographic thicknesses can be selected, the dose profile determination shall be performed for each available nominal tomographic section thickness;

(3) The CTDI along the two axes specified in He-P 4046.02 (l)(1) shall be measured;

(4) The CT dosimetry phantom shall be oriented so that the measurement point 1.0centimeter from the outer surface and within the phantom is in the same angular position within the gantry as the point of maximum surface CTDI identified; and

(5) The CT conditions of operation shall correspond to typical values used by the registrant for body parts represented by that phantom type.

(i) Calibration procedures shall be in writing.

(j) Records of calibrations performed shall be maintained for inspection by DHHS/RHS.

(k) The spot check procedures shall be in writing and shall have been developed by a qualified expert.

(l) The spot check procedures shall incorporate the use of a CT dosimetry phantom capable of providing an indication of contrast scale, noise, nominal tomographic section thickness, resolution capability of the system for low and high contrast objects, and measuring the mean CTN for water or other reference material.

(m) All spot checks shall be included in the CT calibration and at time intervals and under system conditions specified by a qualified expert.

(n) Spot checks shall include acquisition of images obtained with the CT dosimetry phantom(s) using the same processing mode and CT conditions of operation as are used to perform calibrations.

(o) The spot check images shall be retained, until a new calibration is performed, as images stored in digital form on a backed-up storage medium compatible with the CT x-ray system.

(p) Written records of the spot checks performed shall be maintained for inspection by DHHS/RHS.

(q) The CT x-ray system shall not be operated except by a person who has been specifically trained in its operation.

(r) Information shall be available at the control panel regarding the operation and calibration of the system to include the following:

(1) Dates of the latest calibration and spot-checks and the location within the facility where the results of those tests may be obtained;

(2) Instructions on the use of the CT dosimetry phantom(s) including a schedule of spot-checks appropriate for the system, allowable variations for the indicated parameters, and the results of at least the most recent spot-checks conducted on the system;

(3) The distance in millimeters between the tomographic plane and the reference plane if a reference plane is utilized;

(4) A current technique chart available at the control panel which specifies for each routine examination the CT conditions of operation and the number of scans per examination; and

(5) If the calibration or spot- check of the CT x-ray system identifies that a system operating parameter has exceeded a tolerance established by the qualified expert, use of the CT x-ray system on patients shall be limited to those uses permitted by established written instructions of the qualified expert.

He-P 4046.14 Mammography X-ray System Requirements.

(a) In addition to other rules pertaining to radiation safety, registration and use of radiation machines, only radiation machines pursuant to the “Mammography Quality Standards Reauthorization Act of 1998,” Public Law 105-248, and 21 CFR Part 900, shall be used for screening and diagnostic mammography.

(b) A facility performing screening and diagnostic mammography shall have a valid certificate issued by the US Department of Health and Human Services, pursuant to the “Mammography Quality Standards Reauthorization Act of 1998,” Public Law 105-248, and 21 CFR Part 900.

Source. #8808, eff 1-24-07; ss by #10763, INTERIM, eff 1-23-15, EXPIRES: 7-22-15; ss by #10893, eff 7-21-15 (from He-P 4046.13)

He-P 4046.15 Bone Densitometry.

(a) When an application for registration of a new or additional bone densitometry machines is received by DHHS/RHS in accordance with He-P 4040, registration shall be denied unless the application is accompanied by the following information:

(1) A detailed description of the x-ray examinations proposed in the screening program;

(2) A description of the diagnostic x-ray quality control program;

(3) The qualifications of each person who will be operating the x-ray system(s);

(4) The qualifications of the person who will be supervising the operators of the x-ray systems(s), the extent of supervision, and the method of work performance evaluation; and

(5) The name and address of the person who will interpret the radiograph(s).

(b) Bone densitometry systems shall be:

(1) Certified by the manufacturer pursuant to the Medical Device Act and Subchapter C- Electronic Product Radiation Control (EPRC) of Chapter V of the Federal Food, Drug and Cosmetic Act;

(2) Licensed in accordance with He-P 4040 of these regulations; and

(3) Maintained and operated in accordance with the manufacturer’s specifications.

(c) Bone densitometry systems with a stepless beam limitation device shall be provided with means to both size and align the x-ray field such that at a plane of the image receptor the x-ray field does not extend beyond 2 percent of the SID.

(d) Operators of bone densitometry systems shall be:

(1) Licensed as a practitioner of the healing arts; or

(2) Complete a training course on bone densitometry which is provided by the densitometer manufacturer or vendor, and which shall include:

a. Basic radiation protection;

b. Operating procedures for bone densitometry systems, to include use of various system functions, safety and maintenance; and

c. Patient positioning for the types of examinations performed.

(e) During the operation of any bone densitometry system:

(1) The operator, ancillary personnel, and members of the general public shall be positioned at least one meter from the patient and bone densitometry system during the examination; and

(2) The operator shall advise the patient that the bone densitometry examination is a type of x-ray procedure.

(f) The registrant shall keep maintenance records for bone densitometry records as prescribed by He-P 4045.05. These records shall be maintained for inspection DHHS/RHS for a minimum period of 5 years.

(g) Bone densitometry on human patients shall be conducted only under the prescription of a licensed practitioner of the healing arts.

Source. #10893, eff 7-21-15 (from He-P 4046.14)

He-P 4046.16 Veterinarian Facilities – Radiation or MRI Machine General Requirements.

(a) All veterinarian facilities shall be subject to the following requirements:

(1) Radiation machine general requirements set forth in He-P 4046.01; and

(2) Tube potential vs., minimum half-value layer set forth in Table 4046.1.

(b) Veterinarians using fluoroscopic systems shall be subject to requirements for:

(1) General requirements and activation of the fluoro tube set forth in He-P 4046.02;

(2) Barrier transmitted exposure rate limits set forth in He-P 4046.04;

(3) Additional requirements set forth in He-P 4046.05; and

(4) Certified diagnostic systems set forth in He-P 4046.07.

(1) Dental intraoral radiographic systems, other than hand-held systems set forth in He-P 4046.08; and

(2) Hand-held dental intraoral systems set forth in He-P 4046.09.

(d) Veterinarians using computed tomography systems shall be subject to requirements for:

(1) Equipment requirements set forth in He-P 4046.11;

(2) Facility design requirements set forth in He-P 4046.12; and

(3) Surveys, calibrations, spot checks, and operating conditions set forth in He-P 4046.13.

Source. #10893, eff 7-21-15

He-P 4046.17 Magnetic Resonance Imaging (MRI) Systems. MRI systems shall be:

(a) Certified by the manufacturer pursuant to the Medical Device Act and Subchapter C-Electronic Product Radiation Control (EPRC) of Chapter V of the Federal Food, Drug and Cosmetic Act;

(b) Registered in accordance with He-P 4040; and

Source. #10893, eff 7-21-15

PART He-P 4047 USE OF RADIATION MACHINES: THERAPEUTIC RADIATION MACHINES

He-P 4047.01 Purpose. He-P 4047 establishes requirements, for which the registrant is responsible for use of therapeutic radiation machines.

Source. #6827, eff 8-6-98; ss by #8692, INTERIM, eff 7-27-06, EXPIRES: 2-2-07; ss by #8808, eff 1-24-07; ss by #10764, INTERIM, eff 1-23-15, EXPIRES: 7-22-15; ss by #10894, eff 7-21-15

New. #14598, INTERIM, eff 5-22-26, EXPIRES: 11-18-26

He-P 4047.02 Scope. The provisions of He-P 4047 are in addition to, and are not substitutions for, other applicable provisions of this chapter.

Source. #6827, eff 8-6-98; ss by #8692, INTERIM, eff 7-27-06, EXPIRES: 2-2-07; ss by #8808, eff 1-24-07; ss by #10764, INTERIM, eff 1-23-15, EXPIRES: 7-22-15; ss by #10894, eff 7-21-15

New. #14598, INTERIM, eff 5-22-26, EXPIRES: 11-18-26

He-P 4047.03 Definitions. The following definitions apply specifically to Part He-P 4047 and shall be in addition to definitions in He-P 4003 and He-P 4041:

(a) “Absorbed dose (D)” means the mean energy imparted by ionizing radiation to matter, and is determined as the quotient of dE by dm, where dE is the mean energy imparted by ionizing radiation to matter of mass dm, and is expressed in the SI unit of joule per kilogram and the special name “gray” (Gy).

(b) “Absorbed dose rate” means absorbed dose per unit time for radiation machines with timers, or dose monitor unit per unit time for linear accelerators.

(c) “Air kerma (K)” means the kinetic energy released in air by ionizing radiation, and is determined as the quotient of dE by dM, where dE is the sum of the initial kinetic energies of all the charged ionizing particles liberated by uncharged ionizing particles in air of mass dM, and is expressed in the SI unit of joule per kilogram, and the special name the “gray” (Gy).

(d) “Beam scattering foil” means a thin piece of material placed in the beam to scatter a beam of electrons in order to provide a more uniform electron distribution in the useful beam.

(e) “Bent beam linear accelerator” means a linear accelerator geometry in which the accelerated electron beam must change direction by passing through a bending magnet.

(f) “Conventional simulator” means any x-ray system designed to produce the geometric conditions of the radiation therapy equipment.

(g) “Dose monitor unit (DMU)” means a unit response from the beam monitoring system from which the absorbed dose can be calculated.

(h) “Dosimetrist” means a person who generates and calculates radiation dose distributions under the direction of a medical physicist and a radiation oncologist.

(i) “Electronic brachytherapy” means a method of radiation therapy where an electrically generated source of ionizing radiation is placed in or near the tumor or target tissue to deliver therapeutic radiation dosage.

(j) “Electronic brachytherapy device” means the system used to produce and deliver therapeutic radiation including the x-ray tube, the control mechanism, the cooling system, and the power source.

(k) “Electronic brachytherapy source” means the x-ray tube component used in an electronic brachytherapy device.

(l) “External beam radiation therapy” means therapeutic irradiation in which the source of radiation is at a distance from the body.

(m) “Field-flattening filter” means a filter used to homogenize the absorbed dose rate over the radiation field.

(n) “Gantry” means that part of a radiation therapy system supporting and allowing movements of the radiation head about a center of rotation.

(o) “High energy external beam therapy” means photons and electrons with energies greater than equal to one MV or one MeV.

(p) “Intensity Modulated Radiation Therapy (IMRT)” means radiation therapy that uses non-uniform radiation beam intensities which have been determined by various computer based and automated optimization techniques.

(q) “Interruption of irradiation” means the stopping of irradiation with the possibility of continuing irradiation without resetting of operating conditions at the control panel.

(r) “Kilovolt (kV)” or “kilo electron volt (keV)” means the energy equal to that acquired by a particle with one electron charge in passing through a potential difference of one thousand volts in a vacuum.

(s) “Megavolt (MV)” or “mega electron volt (MeV)” means the energy equal to that acquired by a particle with one electron charge in passing through a potential difference of one million volts in a vacuum.

(t) “Misadministration” means the administration of an external beam radiation therapy dose:

(1) Involving the wrong patient;

(2) Involving the wrong treatment modality;

(3) Involving the wrong treatment site;

(4) When the treatment consists of 3 or fewer fractions and the calculated total administered dose differs from the total prescribed dose by more than 10 percent of the total prescribed dose;

(5) When the calculated weekly administered dose differs from the weekly prescribed dose by more than 30 percent; or

(6) When the calculated total administered dose differs from the total prescribed dose by more than 20 percent of the total prescribed dose.

(u) “Mobile Electronic Brachytherapy Service” means transportation of an electronic brachytherapy device to provide electronic brachytherapy at an address that is not the address of record.

(v) “Monitor unit (MU)” means “dose monitor unit” as defined in (g) above.

(w) “Moving beam radiation therapy” means radiation therapy with any planned displacement of radiation field or patient relative to each other, or with any planned change of absorbed dose distribution.

(x) “Nominal treatment distance” means:

(1) For electron radiation, the distance from the scattering foil, virtual source, or exit window of the electron beam to the entrance surface of the irradiation object along the central axis of the useful beam;

(2) For x-ray irradiation, the virtual source or target to isocenter distance along the central axis of the useful beam; and

(3) For non-isocentric x-ray irradiation equipment, the distance along the central axis shall be that specified by the manufacturer.

(y) “Periodic quality assurance check” means a procedure which is performed to ensure that a previous calibration continues to be valid.

(z) “Phantom” means an object behaving in essentially the same manner as tissue, with respect to absorption or scattering of the ionizing radiation in question.

(aa) “Practical range of electrons” means a classical electron range where the only remaining contribution to dose is from bremsstrahlung x-rays.

(ab) “Prescribed dose” means the total dose and dose per fraction as documented in the written directive.

(ac) “Primary dose monitoring system” means a system which will monitor the useful beam during irradiation and which will terminate irradiation when a pre-selected number of dose monitor units have been delivered.

(ad) “Radiation field” means “useful beam” as defined in He-P 4041(fn).

(ae) “Radiation head” means the structure from which the useful beam emerges.

(af) “Radiation therapy physicist” means an individual qualified in accordance with He‑P 4047.

(ag) “Recordable event” means the administration of an external beam radiation therapy dose when the calculated weekly administered dose differs by 15 percent or more from the weekly prescribed dose.

(ah) “Redundant beam monitoring system” means a combination of 2 dose monitoring systems in which each system is designed to terminate irradiation in accordance with a pre-selected number of dose monitor units.

(ai) “Scattered primary radiation” means that scattered radiation which has been deviated in direction only by materials irradiated by the useful beam.

(aj) “Secondary dose monitoring system” means a system which will terminate irradiation in the event of failure of the primary dose monitoring system.

(ak) “Shadow tray” means a device attached to the radiation head to support auxiliary beam blocking material.

(al) “Simulator” or “radiation therapy simulation system” means an x-ray system intended for localizing the volume to be exposed during radiation therapy and reproducing the position and size of the therapeutic irradiation field.

(am) “Source-skin distance (SSD)” means “target-skin distance” as defined in (ap) below.

(an) “Stationary beam radiation therapy” means radiation therapy without displacement of one or more mechanical axes relative to the patient during irradiation.

(ao) “Target” means that part of an x-ray tube or accelerator onto which is directed a beam of accelerated particles to produce ionizing radiation or other particles.

(ap) “Target-skin distance (TSD)” means the distance measured along the beam axis from the center of the front surface of the x-ray target or electron virtual source to the surface of the irradiated object or patient.

(aq) “Therapeutic radiation machine” means x-ray or electron producing equipment designed and used for external beam radiation therapy. For the purpose of these regulations, devices used to administer electronic brachytherapy shall also be considered therapeutic machines.

(ar) “Virtual Simulator” means a computed tomography (CT) unit used in conjunction with relevant software which recreates the treatment machine; and that allows import manipulation, display and storage of images from CT or other imaging modalities.

(as) “Virtual source” means a point from which radiation appears to originate.

(at) “Written directive” means an order in writing for a specific patient, dated and signed by an authorized user prior to the administration of radiation which contains the total dose, dose per fraction, treatment site, and overall treatment period.

Source. #6827, eff 8-6-98; ss by #8692, INTERIM, eff 7-27-06, EXPIRES: 2-2-07; ss by #8808, eff 1-24-07; ss by #10764, INTERIM, eff 1-23-15, EXPIRES: 7-22-15; ss by #10894, eff 7-21-15

New. #14598, INTERIM, eff 5-22-26, EXPIRES: 11-18-26

He-P 4047.04 General Administrative Requirements for Facilities Using Therapeutic Radiation Machines.

(a) The use of therapeutic radiation machines shall be by, or under the supervision of, a licensed practitioner of the healing arts.

(b) The registrant shall be responsible for directing the operation of the therapeutic radiation machines which have been registered with DHHS/RHS.

(c) The registrant shall ensure that the requirements of He-P 4047 are met in the operation of the therapeutic radiation machine(s).

(d) A therapeutic radiation machine which does not meet the provisions of this part shall not be used for irradiation of patients.

(e) The registrant for any therapeutic radiation machine subject to He-P 4047 shall require the authorized user to be a physician who:

(1) Is certified in:

a. Radiation oncology or therapeutic radiology by the American Board of Radiology;

b. Radiation oncology by the American Osteopathic Board of Radiology;

c. Radiology, with specialization in radiotherapy, as a British “Fellow of the Faculty of Radiology” or “Fellow of the Royal College of Radiology”; or

d. Therapeutic radiology by the Canadian Royal College of Physicians and Surgeons; or

(2) Is in the active practice of therapeutic radiology, and has:

a. Completed 200 hours of instruction in basic radiation techniques applicable to the use of an external beam radiation therapy unit;

b. Completed 500 hours of supervised work experience; and

c. A minimum of 3 years supervised clinical experience.

(f) To satisfy the requirement for instruction in (e)(2)a. above, the classroom and laboratory training shall include:

(1) Radiation physics and instrumentation;

(2) Radiation protection;

(3) Mathematics pertaining to the use and measurement of ionization radiation; and

(4) Radiation biology.

(g) To satisfy the requirement for supervised work experience in (e)(2)b. above, training shall:

(1) Be under the supervision of an authorized user; and

(2) Include:

a. Review of the full calibration measurements and periodic quality assurance checks;

b. Evaluation of prepared treatment plans;

c. Calculation of treatment times and patient treatment settings;

d. Use of administrative controls to prevent misadministrations;

e. Implementation of emergency procedures to be followed in the event of the abnormal operation of a external beam radiation therapy unit or console; and

f. The checking and use of radiation survey meters.

(h) To satisfy the requirement for a period of supervised clinical experience in (e)(2)c. above, training shall include:

(1) One year in a formal training program approved by:

a. The Residency Review Committee for Radiology of the Accreditation Council for Graduate Medical Education; or

b. The Committee on Postdoctoral Training of the American Osteopathic Association;

(2) An additional 2 years of clinical experience in therapeutic radiology under the supervision of an authorized user; and

(3) The following training:

a. Examining individuals;

b. Reviewing individuals’ case histories to determine their suitability for external beam radiation therapy treatment, and any limitations and contraindications;

c. Selecting proper dose;

d. Selecting how the dose is to be administered;

e. Calculating the external beam radiation therapy doses;

f. Collaborating with the authorized user in the review of patients’ progress;

g. Considering of the need to modify originally prescribed doses or treatment plans as warranted by patients’ reaction to radiation;

h. Post-administration follow-up; and

i. Post-administration review of case histories.

(i) Notwithstanding the requirements of (e)(1) and (e)(2) above, the registrant for any therapeutic radiation machine subject to He-P 4047 shall also submit the training of the prospective authorized user physician for DHHS/RHS review.

(j) A physician shall not act as an authorized user for any therapeutic radiation machine until such time as said physician’s training has been reviewed and approved by DHHS/RHS.

(k) The registrant for any therapeutic radiation machine subject to He-P 4047 shall require the radiation therapy physicist to be registered with DHHS/RHS, under the provisions of He-P 4040, as a provider of radiation services in the area of calibration and compliance surveys of external beam radiation therapy units, and either:

(1) Be certified by:

a. The American Board of Radiology in:

1. Therapeutic radiological physics;

2. Roentgen-ray and gamma-ray physics;

3. X-ray and radium physics; or

4. Radiological physics;

b. The American Board of Medical Physics in Radiation Oncology Physics; or

c. The Canadian College of Medical Physics; or

(2) Alternately, the radiation therapy physicist shall meet the following requirements:

a. Hold a master’s or doctor’s degree in physics, medical physics, engineering, applied mathematics, biophysics, radiological physics, or health physics from an accredited college or university;

b. Have completed one year of full time training in therapeutic radiological physics;

c. Have completed one year full-time work experience under the supervision of a radiation therapy physicist at a medical institution; and

d. The training and work experience as required in b. and c. above, shall be conducted in a clinical radiation facility that provides high-energy external beam radiation therapy.

(l) To meet the requirement in (k)(2)c. above, the individual shall have performed the tasks listed in He-P 4047.05(a) through (f), and He-P 4047.06(r) and (s), and He-P 4047.07(u) and (v), under the supervision of a radiation therapy physicist during the year of work experience.

(m) Notwithstanding the provisions of (k)(2) and (l) above, certification pursuant to (k)(1) above shall be required on or before December 31, 1999 for all persons currently qualifying as a radiation therapy physicist pursuant to (k) above.

(n) Each individual who operates a therapeutic radiation machine for medical use shall:

(1) Be a registered radiation therapy technologist with the American Registry of Radiologic Technologists (ARRT);

(2) Submit evidence that they have satisfactorily completed a radiation therapy technologist training program that complies with the requirements of the Joint Review Committee on Education in Radiologic Technology; or

(3) Be a student working under the direct supervision and in the physical presence of a registered radiation therapy technologist.

(o) The names and training of all personnel currently operating a therapeutic radiation machine shall be kept on file at the facility.

(p) Information about former operators shall be retained for a period of at least 2 years beyond the last date they were authorized to operate a therapeutic radiation machine at that facility.

(q) Written safety procedures and rules shall be developed by a radiation therapy physicist.

(r) Written safety procedures and rules shall be available in the control area of a therapeutic radiation machine, including any restrictions required for the safe operation of the particular therapeutic radiation machine.

(s) The operator shall be able to demonstrate familiarity with the procedures and rules required in (q) and (r) above.

(t) Individuals shall not be exposed to the useful beam except for medical therapy purposes and unless such exposure has been ordered in writing by an authorized user.

(u) The provision in (t) above shall specifically prohibit deliberate exposure of an individual for training, demonstration, or other non-healing-arts purposes.

(v) Notwithstanding the provisions of (e)(1) and (e)(2) above, a registrant may permit any physician to act as a visiting authorized user under the term of the registrant’s Certificate of Registration for up to 60 days per calendar year under the following conditions:

(1) The visiting authorized user has the prior written permission of the registrant’s management;

(2) The use occurs on behalf of an institution, or the institution’s radiation safety committee;

(3) The visiting authorized user meets the requirements established for authorized user(s) in (e)(1) and (e)(2) above; and

(4) The registrant maintains copies of all records specified by the paragraph for 5 years after the records are made.

(w) All individuals associated with the operation of a therapeutic radiation machine shall be instructed in the provisions of the registrant’s quality management program.

(x) All individuals associated with the operation of a therapeutic radiation machine shall comply with the provisions of the registrant’s quality management program.

(y) All individuals associated with the operation of a therapeutic radiation machine shall be subject to the requirements of He-P 4020 through He-P 4022.

(z) The registrant shall maintain for inspection by DHHS/RHS the following information in a separate file or package for each therapeutic radiation machine:

(1) Report of acceptance testing;

(2) Records of all:

a. Surveys with date(s) performed;

b. Calibrations with date(s) performed;

c. Periodic, dated, quality assurance checks of the therapeutic radiation machine required by He-P 4047; and

d. The name(s) of the person(s) who performed such activities;

(3) Records of:

a. Maintenance, with the date(s) it was performed;

b. Any modifications, with the date(s) the modifications were performed on the therapeutic radiation machine; and

c. The name(s) of the person(s) who performed such services; and

(4) The signature of the person authorizing the return of therapeutic radiation machine to clinical use after service, repair, or upgrade.

(aa) All records required by He-P 4047 shall be retained until disposal is authorized by DHHS/RHS unless another retention period is specifically authorized in He-P 4047.

(ab) All required records shall be retained in an active file from at least the time of generation until the next DHHS/RHS inspection.

(ac) Any required record generated prior to the last DHHS/RHS inspection may be microfilmed or otherwise archived as long as a complete copy of said record can be retrieved until such time as DHHS/RHS authorizes final disposal.

Source. #6827, eff 8-6-98; ss by #8692, INTERIM, eff 7-27-06, EXPIRES: 2-2-07; ss by #8808, eff 1-24-07; ss by #10764, INTERIM, eff 1-23-15, EXPIRES: 7-22-15; ss by #10894, eff 7-21-15

New. #14598, INTERIM, eff 5-22-26, EXPIRES: 11-18-26

He-P 4047.05 General Technical Requirements for Facilities Using Therapeutic Radiation Machines.

(a) The registrant shall ensure that radiation protection surveys of all new facilities, and existing facilities not previously surveyed, are performed with an operable radiation measurement survey instrument calibrated in accordance with He-P 4047.08.

(b) The radiation protection survey shall be performed by, or under the direction of, a radiation therapy physicist or a qualified expert.

(c) The radiation protection survey shall verify that, with the therapeutic radiation machine in a “BEAM-ON” condition, with the largest clinically available treatment field and with a scattering phantom in the useful beam of radiation, the following requirements are met:

(1) Radiation levels in restricted areas are not likely to cause personnel exposures in excess of the limits specified in He-P 4020.05; and

(2) Radiation levels in unrestricted areas do not exceed the limits specified in He-P 4020.13(a) and (b).

(d) In addition to the requirements of (a) above, a radiation protection survey shall also be performed prior to any subsequent medical use; and:

(1) After making any change in the treatment room shielding;

(2) After making any change in the location of the therapeutic radiation machine within the treatment room;

(3) After relocating the therapeutic radiation machine to a different treatment room; or

(4) Before using the therapeutic radiation machine in a manner that could result in increased radiation levels in areas outside the external radiation therapy treatment room.

(e) The survey record required in (d) above shall include:

(1) All instances where the facility is in violation of applicable rules;

(2) The date of the measurements;

(3) The reason for the survey;

(4) The manufacturer’s name;

(5) Model number of the therapeutic radiation machine;

(6) Serial number of the therapeutic radiation machine;

(7) The instrument(s) used to measure radiation levels;

(8) A diagram of the areas surrounding the treatment room that were surveyed;

(9) The measured dose rate at several points in each area expressed in microsieverts or millirems per hour;

(10) The calculated maximum level of radiation over a period of 1 week for each restricted and unrestricted area; and

(11) The signature of the individual responsible for conducting the survey.

(f) If the results of the surveys required by (a) and (d) above indicate any radiation levels in excess of the respective limit specified in He-P 4020, the registrant shall lock the control in the “OFF” position and not use the unit except as might be necessary to repair, replace, or test the therapeutic radiation machine, test the therapeutic radiation machine shielding, or test the treatment room shielding.

(g) If the survey required by (a) and (d) above indicates that an individual in an unrestricted area might be exposed to levels of radiation greater than those permitted by He-P 4020.13(a) and (b), before beginning the treatment program the registrant shall:

(1) Equip the unit with beam direction interlocks or add additional radiation shielding to ensure compliance with He-P 4020.13(a) and (b);

(2) Perform the survey required by (a) above again; and

(3) Include in the record required by (e) above:

a. The results of the initial survey;

b. A description of the modification made to comply with (g)(1) above; and

c. The results of the second survey.

(h) The registrant shall have a dosimetry system available for use which has been calibrated by the National Institute for Standards and Technology (NIST) or by an American Association of Physicists in Medicine (AAPM) Accredited Dosimetry Calibration Laboratory (ADCL) as follows:

(1) For beams with energies greater than 1 MV (1 MeV), the dosimetry system shall have been calibrated for Cobalt-60; and

(2) For beams with energies equal to or less than 1 MV (1 MeV), the dosimetry system shall have been calibrated at an energy or for an energy range appropriate for the radiation being measured.

(i) The calibration of the dosimetry system required in (h) above shall have been performed within the previous 24 months, and after any servicing that may have affected system calibration.

(j) An independent survey shall be conducted by a radiation therapy physicist or qualified expert other than the person performing the original survey prior to the system being used except as described in He-P 4047.05(f).

(k) The registrant shall have available for use a dosimetry system for quality assurance check measurements. To meet this requirement, the system shall be compared with a system that has been calibrated in accordance with (h) through (j) above. This comparison shall have been performed within the previous 12 months, and after each servicing that may have affected system calibration. The quality assurance check system shall be the same system used to meet the requirements in (h) through (j) above.

(l) The registrant shall maintain a record of each dosimetry system calibration, intercomparison, and comparison for each therapeutic radiation machine.

(m) For each calibration, intercomparison, or comparison, the record shall include:

(1) The date;

(2) The model numbers of the instruments that were calibrated;

(3) The serial numbers of the instruments that were calibrated, intercompared, compared, or used to meet the requirements in (h) through (k) above;

(4) The correction factors that were determined;

(5) The names of the individuals who performed the calibration, intercomparison, or comparison; and

(6) Evidence that the intercomparison was performed by, or under the direct supervision and in the physical presence of, a radiation therapy physicist.

(n) The registrant for any therapeutic radiation machine shall be able to furnish a copy of the records required in this section to DHHS/RHS upon request, within 30 days following completion of the action that initiated the record requirement.

(o) Each registrant using radiation therapy machines shall establish and maintain a quality management program to provide high confidence that radiation will be administered as directed by the authorized user.

(p) The registrant shall make modifications to the quality management program to increase the program’s efficiency.

(q) The quality management program required by (o) above shall include written policies and procedures to meet the following specific objectives:

(1) Prior to administration, a written directive shall be prepared for any external beam radiation therapy dose;

(2) Notwithstanding (q)(1) above, a written revision to an existing written directive shall be acceptable provided that the revision is dated and signed by an authorized user prior to administration of the external beam radiation therapy dose or the next external beam radiation therapy fractional dose;

(3) If, because of the patient’s condition, a delay in order to provide a written revision to an existing written directive would jeopardize the patient’s health, an oral revision to an existing written directive shall be acceptable, provided that the oral revision is documented immediately in the patient’s record and a revised written directive is signed by an authorized user within 48 hours of the oral revision;

(4) The written directive shall contain the patient or human research subject’s name, the type and energy of the beam, the total dose, dose per fraction, treatment site, and number of fractions;

(5) A written revision to an existing written directive shall be made provided that the revision is dated and signed by an authorized user prior to the administration of the therapeutic radiation machine dose, or the next fractional dose; and

(6) The registrant shall retain a copy of each written directive for 3 years.

(r) The registrant shall develop, implement, and maintain written procedures to provide high confidence that:

(1) Prior to the administration of each course of radiation treatment, the patient's identity is verified, by more than one method, as the individual named in the written directive;

(2) Each administration is in accordance with the written directive;

(3) The therapeutic radiation machine final treatment plans and related calculations are in accordance with the respective written directives by:

a. Checking both manual and computer generated dose calculations to verify they are correct and in accordance with the written directive; and

b. Verifying that any computer generated calculations are correctly transferred into consoles of authorized therapeutic medical units;

(4) Any unintended deviation from the written directive is identified and evaluated, and appropriate action is taken; and

(5) The registrant retains a copy of the procedures for administrations for the duration of the registration.

(s) Each registrant using radiation therapy equipment shall have a quality management program that specifies staff, staff duties and responsibilities, equipment, and procedures.

(t) Each existing registrant shall submit to DHHS/RHS a copy of the written quality management program that has been implemented.

(u) The registrant shall include as a part of the quality management program the following:

(1) An evaluation of a representative sample of patient administrations and a review of all recordable events, and all misadministrations, if any, to verify compliance with all aspects of the quality management program;

(2) Reviews conducted at intervals not to exceed 12 months;

(3) An evaluation of each review to determine the effectiveness of the quality management program and, if necessary to make modifications to meet the requirements of this part; and

(4) Records of each review, including the evaluations and findings of the review, which shall be retained for 3 years.

(v) Each registrant shall report any event resulting from intervention of a patient or human research subject in which the administration of therapeutic radiation machine results, or will result in, unintended permanent functional damage to an organ or a physiological system as determined by a physician.

(w) Other than events that result from intervention by a patient or human research subject each registrant shall report any event in which the administration of a therapeutic radiation machine therapy dose:

(1) Involved the wrong patient, wrong treatment modality, or wrong treatment site; or

(2) The calculated weekly administered dose differing from the weekly prescribed dose by more than 30 percent; or

(3) The calculated total administered dose differing from the total prescribed dose by more than 20 percent of the total prescribed dose.

(x) The registrant shall evaluate and respond, within 30 days after discovery of a recordable event, by:

(1) Assembling the relevant facts including the cause;

(2) Identifying what, if any, corrective action is required to prevent recurrence; and

(3) Retaining a record, for 3 years, of the relevant facts, and the corrective action, if any, which was taken.

(y) The registrant shall evaluate each misadministration.

(z) The registrant shall take the following actions in response to a misadministration:

(1) Notify DHHS/RHS by telephone no later than the next business day after discovery of the misadministration;

(2) Submit a written report to DHHS/RHS within 15 days after discovery of the misadministration including:

a. The registrant’s name;

b. The prescribing physician’s name;

c. A brief description of the event;

d. Why the event occurred;

e. The effect on the patient;

f. What improvements are needed to prevent recurrence;

g. Actions taken to prevent recurrence;

h. Whether the registrant notified the patient or the patient’s responsible relative or guardian;

i. What information was provided to the patient; and

j. Shall not include the patient’s name or other information that could lead to identification of the patient;

(3) Notify the referring physician;

(4) Notify the patient of the misadministration no later than 24 hours after its discovery, unless the referring physician personally informs the registrant either that they will inform the patient or that, based on medical judgment, telling the patient would be harmful;

(5) Notify the patient as soon as possible thereafter if the referring physician or patient cannot be reached within 24 hours;

(6) Not delay any appropriate medical care for the patient, including any necessary remedial care as a result of the misadministration, because of any delay in notification;

(7) If a verbal notification is made, the registrant shall inform the patient, or appropriate responsible relative or guardian, that a written description of the event can be obtained from the registrant upon request. The registrant shall provide such a written description if requested; and

(8) Retain a record of each misadministration for 3 years, including:

a. The names of all individuals involved;

b. The patient’s Social Security number or other identification number;

c. A brief description of the event;

d. Why it occurred and the effect on the patient;

e. What improvements are needed to prevent recurrence;

f. The actions taken to prevent recurrence; and

g. Whether the patient was notified or not.

(aa) Aside from the notification requirements in (z) above, nothing in this section shall affect any rights or duties of registrants and physicians in relation to each other, to the patient affected by the event, or to that patient’s responsible relative or guardian.

Source. #6827, eff 8-6-98; ss by #8692, INTERIM, eff 7-27-06, EXPIRES: 2-2-07; ss by #8808, eff 1-24-07; ss by #10764, INTERIM, eff 1-23-15, EXPIRES: 7-22-15, ss by #10894, eff 7-21-15

New. #14598, INTERIM, eff 5-22-26, EXPIRES: 11-18-26

He-P 4047.06 Therapeutic Radiation Machines of Less Than 500 kV.

(a) When the x-ray tube is operated at its maximum rated tube current for the maximum kV, the leakage air kerma rate shall not exceed the value specified at the distance specified as follows:

(1) For 5 to 50 kV systems, the leakage air kerma rate measured at any position 5 centimeters from the tube housing assembly shall not exceed 1 mGy (100 mrad) in any one-hour period;

(2) For >50 and <500 kV systems:

a. The leakage air kerma rate measured at a distance of 1 meter from the target in any direction shall not exceed 1 cGy (1 rad) in any one-hour period;

b. This air kerma rate measurement may be averaged over areas no larger than 100 square centimeters; and

c. The air kerma rate at a distance of 5 centimeters from the surface of the tube housing assembly shall not exceed 30 cGy (30 rad) per hour;

(3) For each therapeutic radiation machine, the registrant shall determine, or obtain from the manufacturer, the leakage radiation existing at the positions specified in (a)(1) and (a)(2) above, for the specified operating conditions; and

(4) Records on leakage radiation measurements shall be maintained after installation for inspection by DHHS/RHS.

(b) Permanent diaphragms or cones used for limiting the useful beam shall provide at least the same degree of attenuation as required for the tube housing assembly.

(c) All adjustable or removable beam limiting devices, diaphragms, cones, or blocks shall meet the following requirements:

(1) None shall transmit more than 5 percent of the useful beam for the most penetrating beam used; and

(2) When adjustable or removable beam limiting devices are used, the position and shape of the radiation field shall be indicated by a light beam.

(d) The filter system shall be so designed that:

(1) Filters can not be accidentally displaced at any possible tube orientation;

(2) An interlock system prevents irradiation if the proper filter is not in place;

(3) The air kerma rate escaping from the filter slot shall not exceed 1 cGy (1 rad) per hour at one meter under any operating conditions; and

(4) Each filter shall be marked as to its material of construction and its thickness.

(e) The x-ray tube shall be so mounted that it can not accidentally turn or slide with respect to the housing aperture.

(f) The tube housing assembly shall be capable of being immobilized for stationary portal treatments.

(g) The tube housing assembly shall be marked so that:

(1) It is possible to determine the location of the source to within 5 millimeters; and

(2) Such marking shall be readily accessible for use during calibration procedures.

(h) Contact therapy tube housing assemblies shall have a removable shield of material, equivalent in attenuation to 0.5 millimeters of lead at 100 kV, which can be positioned over the entire useful beam exit port during periods when the beam is not in use.

(i) A timer control device shall be provided to terminate the irradiation after a pre-set time interval and shall:

(1) Have a display;

(2) Be provided at the treatment control;

(3) Have a pre-set time selector;

(4) Have elapsed time or time remaining indicator;

(5) Be a cumulative timer which activates with an indication of “BEAM-ON” and retains its reading after irradiation is interrupted or terminated;

(6) Be able to reset the elapsed time indicator after irradiation is terminated and before irradiation can be re-initiated;

(7) Terminate irradiation when a pre-selected time has elapsed, if any dose monitoring system present has not previously terminated irradiation;

(8) Permit accurate pre-setting and determination of exposure times as short as 1 second;

(9) Not permit an exposure if set at zero;

(10) Not activate until the shutter is opened when irradiation is controlled by a shutter mechanism unless calibration includes a timer error correction to compensate for mechanical lag; and

(11) Be accurate to within 1 percent of the selected value or 1 second, whichever is greater.

(j) The control panel, in addition to the displays required by other provisions in this section, shall have:

(1) An indication of whether electrical power is available at the control panel and if activation of the x-ray tube is possible;

(2) An indication of whether x-rays are being produced;

(3) Means for indicating x-ray tube potential and current;

(4) Means for terminating exposure at any time;

(5) A locking device which will prevent unauthorized use of the therapeutic radiation machine; and

(6) A positive display of specific filter(s) in the beam.

(k) A control panel which may energize more than one x-ray tube shall:

(1) Activate only one x-ray tube at any time;

(2) Have an indication at the control panel identifying which x-ray tube is activated; and

(3) Have an indication at the tube housing assembly when that tube is energized.

(l) There shall be a means of determining the central axis target-to-skin distance to within 1 centimeter and of reproducing this measurement to within 2 millimeters thereafter.

(m) Shutters shall be required as follows:

(1) Unless it is possible to bring the x-ray output to the prescribed exposure parameters within 5 seconds after the x-ray “ON” switch is energized, the beam shall be attenuated by a shutter having a lead equivalency not less than that of the tube housing assembly;

(2) After the unit is at operating parameters, the shutter shall be controlled by the operator from the control panel; and

(3) An indication of shutter position shall appear at the control panel.

(n) Each therapeutic radiation machine equipped with a beryllium or other low-filtration window shall:

(1) Be clearly labeled as such on the tube housing assembly; and

(2) Be provided with a permanent warning device on the control panel that is activated when there is no additional filtration present, in order to indicate that the dose rate is very high.

(o) In addition to the shielding requirements of He-P 4047, the treatment room shall meet the following facility design requirements for therapeutic radiation machines capable of operating in the range 50 kV to 500 kV:

(1) Provision shall be made for continuous two-way aural communication between the patient and the operator at the control panel; and

(2) A viewing system shall:

a. Be provided to permit continuous observation of the patient during irradiation;

b. Enable the operator to observe the patient from the control panel; and

c. Be operational for use of therapeutic radiation machine for patient irradiation.

(p) Treatment rooms which contain a therapeutic radiation machine capable of operating above 150 kV shall meet the following additional requirements:

(1) All protective barriers shall be fixed except for entrance doors or beam interceptors;

(2) The control panel shall be located outside the treatment room or in a totally enclosed booth, which has a shielded ceiling, inside the room;

(3) Interlocks shall be provided such that all entrance doors, including doors to any interior booths, shall be closed before treatment can be initiated or continued;

(4) If the radiation beam is interrupted by any door opening, it shall not be possible to restore the machine to operation without closing the door and re-initiating irradiation by manual action at the control panel; and

(5) When any door referred to in this paragraph is opened while the x-ray tube is activated, the air kerma rate at a distance of 1 meter from the source shall be reduced to less than 1 mGy (100 mrad) per hour.

(q) Full calibration of a therapeutic radiation machine shall be performed by, or under the direct supervision of, a radiation therapy physicist and shall meet the following requirements:

(1) Full calibration shall be performed as follows:

a. Before the first medical use following installation or reinstallation of the therapeutic radiation machine;

b. At intervals not exceeding 1 year; and

c. Before medical use under the following conditions:

1. Whenever quality assurance check measurements indicate that the radiation output differs by more than 5 percent from the value obtained at the last full calibration and the differences cannot be reconciled; and

2. Following any component replacement, major repair, or modification of components that could significantly affect the characteristics of the radiation beam;

(2) Notwithstanding the requirements of (q)(1) c.1. above:

a. Full calibration of therapeutic radiation machines with multi-energy capabilities is required only for those modes or energies that are not within their acceptable range;

b. If the repair, replacement, or modification does not affect all energies, full calibration shall be performed on the affected energy that is in most frequent clinical use at the facility; and

c. Any remaining energies may be validated with quality assurance check procedures against the criteria in (q)(1) c.1 above;

(3) For machines with energies greater than or equal to 10 KeV and less than or equal to 40 KeV full calibration shall include all measurements recommended for annual calibration by National Council on Radiation Protection (NCRP) Report 69, “Dosimetry of X-ray and Gamma Ray Beams for Radiation Therapy in the Energy Range 10 KeV to 50 MeV” (1981), which is incorporated by reference and included in Appendix A. For machines with energies greater than or equal to 40 kV and less than equal to 300 kV, full calibration shall include all measurements recommended for annual calibration by “High Dose-Rate Brachytherapy Treatment Delivery” (1998), AAPM Task Group 59, and “AAPM Protocol for 40-300 kV X-Ray Beam Dosimetry in Radiotherapy and Radiobiology” (2001) by AAPM Task Group 61, both of which are incorporated by reference and included in Appendix A;

(4) The registrant shall maintain a record of each calibration for the duration of the registration; and

(5) The calibration record shall include:

a. The date of the calibration;

b. The manufacturer’s name, model number, and serial number for both the therapeutic machine and the x-ray tube;

c. The model numbers and serial numbers of the instruments used to calibrate the therapeutic radiation machine; and

d. The signature of the radiation therapy physicist responsible for performing the calibration.

(r) Periodic quality assurance checks shall be performed on therapeutic radiation machines subject to this section, which are capable of operation at greater than or equal to 50 kV, as follows:

(1) The registrant shall perform quality assurance checks specified in this paragraph in accordance with written procedures established by the radiation therapy physicist;

(2) The quality assurance check procedures required by (r)(1) above shall specify:

a. The frequency at which tests or measurements are to be performed;

b. That the quality assurance check be performed during the calibration specified in (q) above; and

c. The acceptable tolerance for each parameter measured in the quality assurance check, when compared to the value for that parameter determined in the calibration as specified by (q)(1) above;

(3) The quality assurance check shall investigate the cause for a parameter exceeding a tolerance set by the radiation therapy physicist and correct such parameter before the system is used for patient irradiation;

(4) Whenever a quality assurance check indicates a significant change in the operating characteristics of a system, as specified in the radiation therapy physicist’s quality assurance check procedures, the system shall be recalibrated as specified by (q)(1) above;

(5) The registrant shall use the dosimetry system described in He-P 4047.05(k) to make the quality assurance check required in (r)(2) above;

(6) The registrant shall have the radiation therapy physicist review and sign the results of each radiation output quality assurance check within 30 days of the date that the check was performed;

(7) The registrant shall ensure that the safety quality assurance checks of therapeutic radiation machines are performed at intervals not to exceed 30 days;

(8) The registrant shall ensure that no therapeutic machine is used to administer radiation to humans unless the quality assurance checks will have been performed within the 30-day period immediately prior to said administration;

(9) Safety quality assurance checks shall ensure proper operation of:

a. Electrical interlocks at each external beam radiation therapy room entrance;

b. Proper operation of the “BEAM-ON” and termination switches;

c. Beam condition indicator lights on the access door(s), control console, and in the radiation therapy room;

d. Viewing systems; and

e. If applicable, electrically operated treatment room doors from inside and outside the treatment room;

(10) The registrant shall maintain a record of each quality assurance check for 3 years; and

(11) The quality assurance check records shall include:

a. The date of the quality assurance check;

b. The manufacturer’s name, model number, and serial number for the therapeutic radiation machine;

c. The manufacturer’s name, model number, and serial number of the instrument(s) used to measure the radiation output of the therapeutic radiation machine; and

d. The signature of the individual who performed the periodic quality assurance check.

(s) The following operating procedures shall be met:

(1) The therapeutic radiation machine shall not be used for irradiation of patients unless the requirements of (q) and (r) above have been met;

(2) Therapeutic radiation machines shall not be left unattended unless secured pursuant to (j)(5) above;

(3) When a patient must be held in position for radiation therapy, mechanical supporting, or restraining devices shall be used;

(4) The tube housing assembly shall not be held by an individual during operation unless the assembly is designed to require such holding and the peak tube potential of the system does not exceed 50 kV;

(5) If the tube housing is held, the holder shall wear protective gloves and apron of not less than 0.5 millimeters lead equivalency at 100 kV;

(6) A copy of the current operating and emergency procedures shall be maintained at the therapeutic radiation machine control console;

(7) No individual other than the patient shall be in the treatment room during exposures from therapeutic radiation machines operating above 150 kV; and

(8) At energies less than or equal to 150 kV, any individual, other than the patient, in the treatment room shall be protected by a barrier sufficient to meet the requirements of He-P 4020.

(t) Each facility location authorized to use a therapeutic radiation machine in accordance with this section shall:

(1) Possess appropriately calibrated portable monitoring equipment;

(2) As a minimum, include a portable radiation measurement survey instrument capable of measuring dose rates over the range of 10 μSv (1 mrem) per hour to 10 mSv (1000 mrem) per hour; and

(3) Require the survey instrument(s) to be operable and calibrated in accordance with He-P 4047.08.

Source. #6827, eff 8-6-98; ss by #8692, INTERIM, eff 7-27-06, EXPIRES: 2-2-07; ss by #8808, eff 1-24-07; ss by #10764, INTERIM, eff 1-23-15, EXPIRES: 7-22-15; ss by #10894, eff 7-21-15

New. #14598, INTERIM, eff 5-22-26, EXPIRES: 11-18-26

He-P 4047.07 Therapeutic Radiation Machines - Photon Therapy Systems (500 kV and Above) and Electron Therapy Systems (500 keV and Above).

(a) Each facility location authorized to use a therapeutic radiation machine in accordance with this section shall possess, operable and calibrated in accordance with He-P 4047.08, portable monitoring equipment to include as a minimum a portable radiation measurement survey instrument capable of measuring dose rates over the range 10 µSv (1 mrem) per hour to 10 mSv (1000 mrem) per hour.

(b) Leakage radiation outside the maximum useful beam in photon and electron modes shall meet the following requirements:

(1) The absorbed dose due to leakage radiation (excluding neutrons) at any point outside the maximum sized useful beam, but within a circular plane of radius 2 meters which is perpendicular to and centered on the central axis of the useful beam at the nominal treatment distance or patient plane, shall not exceed a maximum of 0.2 percent and an average of 0.1 percent of the absorbed dose on the central axis of the beam at the nominal treatment distance when measurements are averaged over an area not exceeding 100 square centimeters at a minimum of 16 points uniformly distributed in the plane;

(2) Except for the area defined in (b)(1) above, the absorbed dose due to leakage radiation, excluding neutrons, at 1 meter from the electron path between the electron source and the target or electron window shall not exceed 0.5 percent of the absorbed dose on the central axis of the beam at the nominal treatment distance when measurements are averaged over an area not exceeding 100 square centimeters;

(3) The neutron absorbed dose outside the useful beam shall be in compliance with International Electrotechnical Commission (IEC) Document 60601-2-1, as amended, which is incorporated by reference and included in Appendix A;

(4) For each therapeutic radiation machine, the registrant shall determine, or obtain from the manufacturer, the leakage radiation existing at the positions specified (b)(1)-(3) above for the specified operating conditions; and

(5) Records on leakage radiation measurements shall be maintained after installation for inspection by DHHS/RHS.

(1) For photon radiation, all adjustable or interchangeable beam limiting devices shall attenuate the useful beam such that at the nominal treatment distance, the maximum absorbed dose anywhere in the area shielded by the beam limiting device(s) shall not exceed 5 percent of the maximum absorbed dose on the central axis of the useful beam measured in a 100 square centimeter radiation field or maximum available field size if less than 100 square centimeters;

(2) For electron radiation, all adjustable or interchangeable electron applicators shall attenuate the radiation, including but not limited to photon radiation generated by electrons incident on the beam limiting device and electron applicator and other parts of the radiation head, such that the absorbed dose in a plane perpendicular to the central axis of the useful beam at the nominal treatment distance shall not exceed:

a. For points beyond a line 7 centimeters outside the periphery of the useful beam, a maximum limit of 2 percent and average of 0.5 percent of the absorbed dose on the central axis of the useful beam at the nominal treatment distance; and

b. For points beyond a line 2 centimeters up to 7 centimeters outside the periphery of the useful beam, a maximum limit of 10 percent of the absorbed dose on the central axis of the useful beam at the nominal treatment distance;

(3) Measurements of leakage radiation through the beam limiting for photon radiation devices shall be:

a. Made with the beam limiting devices closed;

b. Made with any residual aperture blocked by at least 2 tenth value layers of suitable absorbing material;

c. Measured independently at the depth of maximum dose for each set of overlapping beam limiting device; and

d. The depth of maximum dose made using a radiation detector of area not exceeding 10 square centimeters;

(4) Measurements of leakage radiation through the electron applicators shall:

a. Be made with the electron beam directed into the air;

b. Use a radiation detector of area up to but not exceeding 1 square centimeter suitably protected against radiation which has been scattered from material beyond the radiation detector; and

c. Be made using one centimeter of water equivalent build up material; and

(5) Leakage radiation through beam limiting devices shall be determined for photon radiation and for electron radiation in radiation therapy machines which operate in both modes.

(d) Filters and wedges used in therapeutic radiation machines shall meet the following requirements:

(1) Each wedge filter which is removable from the system shall be clearly marked with an identification number;

(2) Each removable wedge filter shall have the nominal wedge angle appear on the wedge or wedge tray if permanently mounted to the tray;

(3) If the wedge or wedge tray is significantly damaged, the wedge transmission factor shall be redetermined;

(4) If the absorbed dose rate information required by (i) below relates exclusively to operation with a field flattening filter or beam scattering foil in place, such foil or filter shall be removable only by the use of tools; and

(5) For equipment which utilizes a system of wedge filters, interchangeable field flattening filters, or interchangeable beam scattering foils:

a. Irradiation shall not be possible until a selection of a filter or a positive selection to use “no filter” has been made at the treatment control panel, either manually or automatically;

b. An interlock system shall be provided to prevent irradiation if the filter selected is not in the correct position;

c. A display shall be provided at the treatment control panel showing the wedge filter(s), interchangeable field flattening filter(s), or interchangeable beam scattering foil(s) in use; and

d. An interlock shall be provided to prevent irradiation if any filter or beam scattering foil selection operation carried out in the treatment room does not agree with the filter or beam scattering foil selection operation carried out at the treatment control panel.

(e) The registrant shall determine during acceptance testing, or obtain from the manufacturer, data sufficient to ensure that X ray stray radiation in the useful electron beam, absorbed dose at the surface during X‑ray irradiation and stray neutron radiation in the useful X-ray beam are in compliance with International Electrotechnical Commission (IEC) Document 60601-2-1 which is incorporated by reference and included in Appendix A.

(f) All therapeutic radiation machines subject to this section shall meet the following requirements:

(1) All therapeutic radiation machines shall be provided with:

a. Redundant beam monitoring systems which have sensors fixed in the useful beam during treatment to indicate the dose monitor unit rate;

b. At least 2 independently powered integrating dose meters if manufactured after July 1, 1998; and

c. At least one radiation detector incorporated into a useful beam monitoring system, if manufactured before July 1, 1998; and

(2) The detector and the system into which that detector is incorporated shall meet the following requirements:

a. Each detector shall be removable only with tools;

b. If the detector is movable, it shall be interlocked to prevent incorrect positioning;

c. Each detector shall form part of a beam monitoring system from whose readings in dose monitor units the absorbed dose at a reference point can be calculated;

d. Each beam monitoring system shall be capable of independently monitoring, interrupting, and terminating irradiation;

e. The design of the beam monitoring systems shall ensure that the:

1. Malfunctioning of one system shall not affect the correct functioning of the other system(s); and

2. Failure of either system shall terminate irradiation or prevent the initiation of radiation; and

f. Each beam monitoring system shall have a legible display at the treatment control panel which shall:

1. Maintain a reading until intentionally reset;

2. Have only one scale and no electrical or mechanical scale multiplying factors;

3. Utilize a design such that increasing dose is displayed by increasing numbers; and

4. In the event of power failure, the beam monitoring information displayed at the control panel at the time of failure shall be retrievable in at least one system for a 20-minute period of time.

(g) Bent-beam linear accelerators shall be provided with auxiliary device(s) to monitor beam symmetry which:

(1) Shall be able to detect field asymmetry greater than 10 percent; and

(2) Shall be configured to terminate irradiation if the specifications above cannot be maintained.

(h) Selection and display of dose monitor units shall be as follows:

(1) Irradiation shall not be possible until a new selection of a number of dose monitor units has been made at the treatment control panel;

(2) The pre-selected number of dose monitor units shall be displayed at the treatment control panel until reset manually for the next irradiation;

(3) After termination of irradiation, it shall be necessary to reset the dosimeter display before subsequent treatment can be initiated; and

(4) After termination of irradiation, it shall be necessary for the operator to reset the pre-selected dose monitor units before irradiation can be initiated.

(i) A system shall be provided from whose readings the air kerma rate or absorbed dose rate a reference point can be calculated, and which meets the following requirements:

(1) The dose monitor unit rate shall be displayed at the treatment control panel;

(2) If the equipment can deliver under any conditions an air kerma rate or absorbed dose rate at the nominal treatment distance more than twice the maximum value specified by the manufacturer, a device shall be provided which terminates irradiation when the air kerma rate or absorbed dose rate exceeds a value twice the specified maximum;

(3) The dose rate at which the irradiation will be terminated shall be a record maintained by the registrant;

(4) If the equipment can deliver under any fault condition(s) an air kerma rate or absorbed dose rate at the nominal treatment distance more than 10 times the maximum value specified by the manufacturer, a device shall be provided to prevent the air kerma rate or absorbed dose rate anywhere in the radiation field from exceeding twice the specified maximum value and to terminate irradiation if the excess absorbed dose at the nominal treatment distance exceeds 4 Gy (400 rad);

(5) For each therapeutic radiation machine, the registrant shall determine, or obtain from the manufacturer, the maximum value(s) for the specified operating conditions; and

(6) Records of maximum value(s) shall be maintained at the installation for inspection by DHHS/RHS.

(j) Termination of irradiation by the beam monitoring system or systems during stationary beam radiation therapy shall be as follows:

(1) Each primary system shall terminate irradiation when the pre-selected number of dose monitor units has been detected by the system;

(2) If the original design of the equipment includes a secondary dose monitoring system, that system shall be capable of terminating irradiation when not more than 15 percent or 40 dose monitor units, above the pre-selected number of dose monitor units, set at the control panel, has been detected by the secondary dose monitoring system; and

(3) An indicator on the control panel shall show which monitoring system has terminated radiation.

(k) It shall be possible to terminate irradiation and equipment movement or go from an interruption condition to termination condition at any time from the operator’s position at the treatment control panel.

(l) If a therapeutic radiation machine has an interrupt mode:

(1) It shall be possible to interrupt irradiation and equipment movements at any time from the treatment control panel;

(2) Following an interruption it shall be possible to restart irradiation by operator action without any re-selection of operating conditions; and

(3) If any change is made of a pre-selected value during an interruption, irradiation and equipment movements shall be automatically terminated.

(m) A suitable irradiation control device shall be provided to terminate the irradiation after a pre-set time interval as follows:

(1) A timer shall be provided which has a display at the treatment control panel;

(2) The time provided shall have a pre-set time selector and an elapsed time indicator;

(3) The timer shall be a cumulative timer which activates with an indication of “BEAM-ON” and retains its reading after irradiation is interrupted or terminated;

(4) After irradiation is terminated and before irradiation can be re-initiated, it shall be necessary to reset the elapsed time indicator; and

(5) The timer shall terminate irradiation when a pre-selected time has elapsed, if the dose monitoring systems have not previously terminated irradiation.

(n) Equipment capable of both x‑ray therapy and electron therapy shall meet the following additional requirements:

(1) Irradiation shall not be possible until a selection of radiation type, x-rays or electrons, has been made at the treatment control panel;

(2) The radiation type selected shall be displayed at the treatment control panel before and during irradiation;

(3) An interlock system shall be provided to ensure that the equipment can principally emit only the radiation type which has been selected;

(4) An interlock system shall be provided to prevent irradiation with x-rays, except to obtain an image, when electron applicators are fitted;

(5) An interlock system shall be provided to prevent irradiation with electrons when accessories specific for x-ray therapy are fitted; and

(6) An interlock system shall be provided to prevent irradiation if any selected operations carried out in the treatment room do not agree with the selected operations carried out at the treatment control panel.

(o) Equipment capable of generating radiation beams of different energies shall meet the following requirements:

(1) Irradiation shall not be possible until a selection of energy has been made at the treatment control panel;

(2) The nominal energy value selected shall be displayed at the treatment control panel until reset manually for the next irradiation;

(3) After termination of irradiation, it shall be necessary to reset the nominal energy value selected before subsequent treatment can be initiated;

(4) Irradiation shall not be possible until the appropriate flattening filter or scattering foil for the selected energy is in its proper location; and

(5) The selection of energy shall be in compliance with International Electrotechnical Commission (IEC) Document 60601-2-1, which is incorporated by reference and included in Appendix A.

(p) Therapeutic radiation machines capable of both stationary beam radiation therapy and moving beam radiation therapy shall meet the following requirements:

(1) Irradiation shall not be possible until a selection of stationary beam radiation therapy or moving beam radiation therapy has been made at the treatment control panel;

(2) The mode of operation shall be displayed at the treatment control panel;

(3) An interlock system shall be provided to ensure that the equipment can operate only in the mode which has been selected;

(4) An interlock system shall be provided to prevent irradiation if any selected parameter in the treatment room does not agree with the selected parameter at the treatment control panel;

(5) Moving beam irradiation therapy shall be controlled to obtain the selected relationships between incremental dose monitor units and incremental movement as follows:

a. An interlock system shall be provided to terminate irradiation if the number of dose monitor units delivered in any 10 degrees of rotation or one cm of linear motion differs by more than 20 percent from the selected value;

b. Where angle terminates the irradiation in moving beam radiation therapy, the dose monitor units delivered shall differ by less than 5 percent from the dose monitor unit value selected;

c. An interlock shall be provided to prevent motion of more than 5 degrees or 1 cm beyond the selected limits during moving beam radiation therapy;

d. An interlock shall be provided to require that a selection of direction be made at the treatment control panel in all units which are capable of both clockwise and counter-clockwise moving beam radiation therapy; and

e. Moving beam radiation therapy shall be controlled with both primary position sensors and secondary position sensors to obtain the selected relationships between incremental dose monitor units and incremental movement;

(6) Where the beam monitor system terminates the irradiation in moving beam radiation therapy, the termination of irradiation shall be as required by (j) above; and

(7) An interlock system shall be provided to terminate irradiation if movement:

a. Occurs during stationary beam radiation therapy; or

b. Does not start or stops during moving beam radiation therapy unless stoppage is a pre-planned function.

(q) In addition to shielding adequate to meet requirements of He-P 4047.09, the following design requirements are made for therapeutic radiation machines operating above 500 kV:

(1) All protective barriers shall be fixed, except for access doors to the treatment room or movable beam interceptors;

(2) The control panel shall:

a. Be located outside the treatment room;

b. Provide an indication of whether electrical power is available at the control panel and if activation of the radiation is possible;

c. Provide an indication or whether radiation is being produced; and

d. Include an access control system which will prevent unauthorized use of the therapeutic radiation machine;

(3) Windows, mirrors, closed-circuit television, or an equivalent viewing system shall be provided to permit continuous observation of the patient following positioning and during irradiation and shall be so located that the operator can observe the patient from the treatment control panel;

(4) The therapeutic radiation machine shall not be used for patient irradiation unless at least one viewing system is operational;

(5) Provision shall be made for continuous two-way aural communication between the patient and the operator at the control panel;

(6) The therapeutic radiation machine shall not be used for irradiation of patients unless continuous two-way aural communication is possible;

(7) Treatment room entrances shall be provided with warning lights in a readily observable position near the outside of all access doors, which will indicate when the useful beam is “ON” and when it is “OFF”;

(8) Interlocks shall be provided such that all access controls are activated before treatment can be initiated or continued;

(9) If the radiation beam is interrupted by any access control, it shall not be possible to restore the machine to operation without resetting the access control and re-initiating irradiation by manual action at the control panel;

(10) If the shielding material in any protective barrier requires the presence of a beam interceptor to ensure compliance with He‑P 4020.13, interlocks shall be provided to prevent the production of radiation, unless the beam interceptor is in place, whenever the useful beam is directed at the designated barrier(s);

(11) At least one emergency power cutoff switch in addition to the termination switch shall be located in the radiation therapy room and shall terminate all equipment electrical power including radiation and mechanical motion;

(12) All emergency power cutoff switches shall include a manual reset so that the therapeutic radiation machine cannot be restarted from the unit’s control console without resetting the emergency cutoff switch;

(13) All safety interlocks shall be designed so that any defect or component failure in the safety interlock system prevents or terminates operation of the therapeutic radiation machine; and

(14) Surveys for residual activity shall be conducted on all therapeutic radiation machines capable of generating photon and electron energies above 10 MV prior to machining, removing, or working on therapeutic radiation machine components which might have become activated due to photo-neutron production.

(r) The services of the radiation therapy physicist shall be required in facilities having therapeutic radiation machines with energies of 500 kV and above.

(s) The radiation therapy physicist required in (r) above shall be responsible for:

(1) Full calibration(s) required by He-P (u) below;

(2) Protection surveys required by He-P 4047.05;

(3) Supervision and review of dosimetry;

(4) Beam data acquisition and transfer for computerized dosimetry and supervision of its use;

(5) Quality assurance, including quality assurance check review required by (v)(6) below;

(6) Consultation with the authorized user in treatment planning, as needed; and

(7) Performing calculation and assessments regarding misadministrations.

(t) The following operating procedures shall be required:

(1) If the radiation therapy physicist is not a full-time employee of the registrant, the operating procedures shall specifically address how the radiation therapy physicist is to be contacted for problems or emergencies, as well as the specific actions, if any, to be taken until the radiation therapy physicist can be contacted;

(2) No individual, other than the patient, shall be in the treatment room during treatment or during any irradiation for testing or calibration purposes;

(3) Therapeutic radiation machines shall not be made available for medical use unless the requirements of He-P 4047.05 and (u) and (v) below have been met;

(4) Therapeutic radiation machines, when not in operation, shall be secured to prevent unauthorized use;

(5) When adjustable beam limiting devices are used, the position and shape of the radiation field shall be indicated by a light field;

(6) If a patient must be held in position during treatment, mechanical supporting or restraining devices shall be used; and

(7) A copy of the current operating and emergency procedures shall be maintained at the therapeutic radiation machine control console.

(u) Acceptance testing, commissioning, and full calibration measurements shall be as follows:

(1) Acceptance testing, commissioning, and full calibration of a therapeutic radiation machine shall be performed by, or under the direct supervision of, a radiation therapy physicist;

(2) Acceptance testing and commissioning shall be performed in accordance with “AAPM Code of Practice for Radiotherapy Accelerators” (1994) prepared by AAPM Radiation Therapy Task Group 45, which is incorporated by reference and included in Appendix A, and the manufacturer’s contractual specifications;

(3) Acceptance testing and commissioning shall be conducted before the first medical use following installation or reinstallation of the therapeutic radiation machine;

(4) Full calibration shall include measurement of all parameters required by Table II of “Comprehensive QA for Radiation Oncology” (1994) prepared by AAPM Radiation Therapy Committee Task Group 40, which Report and Table are incorporated by reference and included in Appendix A;

(5) Full calibration shall be performed in accordance with “AAPM Code of Practice for Radiotherapy Accelerators” (1994) prepared by AAPM Radiation Therapy Task Group 45 which is incorporated by reference and included in Appendix A;

(6) It shall not be necessary to complete all elements of a full calibration at the same time, all applicable parameters, for all energies, shall be completed at intervals not exceeding 12 calendar months, unless a more frequent interval is required in Table II of “Comprehensive QA for Radiation Oncology” (1994) prepared by AAPM Radiation Therapy Committee Task Group 40, which is incorporated by reference and included in Appendix A;

(7) The radiation therapy physicist shall perform all elements of a full calibration necessary to determine that all parameters are within acceptable limits as follows:

a. Whenever quality assurance check measurements indicate that the radiation output differs by more than 5 percent from the value obtained at the last full calibration and the difference cannot be reconciled;

b. Therapeutic radiation machines with multi-energy or multi-mode capabilities shall only require measurements for those modes or energies that are not within their acceptable range;

c. Following any component replacement, major repair, or modification of components that could significantly affect the characteristics of the radiation beam;

d. If the repair, replacement, or modification does not affect all modes or energies, measurements shall be performed on the effected mode or energy that is in most frequent clinical use at the facility; and

e. The remaining energies or modes may be validated with quality assurance check procedures against the criteria in (u)(7) above;

(8) The registrant shall use the dosimetry system described in He-P 4047.05(h) and (i) to measure the radiation output for one set of exposure conditions;

(9) The remaining radiation measurements required in (u)(2)-(6) above may be made using a dosimetry system that indicates relative dose rates;

(10) The registrant shall maintain a record of each calibration in an auditable form for the life of the therapeutic radiation machine; and

(11) The record required in (u)(10) above shall include:

a. The date of the calibration;

b. The manufacturer’s name;

c. Model number of the therapeutic machine;

d. Serial number of the therapeutic machine;

e. The model numbers and serial numbers of the instruments used to calibrate the therapeutic radiation machine; and

f. The signature of the radiation therapy physicist responsible for performing the calibration.

(v) Periodic quality assurance checks shall meet the following requirements:

(1) Periodic quality assurance checks shall be performed on all therapeutic radiation machines subject to this section at intervals not to exceed those specified in “Comprehensive QA for Radiation Oncology” (1994), prepared by AAPM Radiation Therapy Committee Task Group 40, which is incorporated by reference and included in Appendix A;

(2) Quality assurance checks shall include determination of central axis radiation output and a representative sampling of periodic quality assurance checks contained in “Comprehensive QA for Radiation Oncology” (1994) prepared by AAPM Radiation Therapy Committee Task Group 40 which is incorporated by reference and included in Appendix A;

(3) Representative sampling as required in (v)(2) above shall include all referenced periodic quality assurance checks in an interval not to exceed 12 consecutive calendar months;

(4) The registrant shall use a dosimetry system which has been intercompared within the previous 12 months with the dosimetry system described in He-P 4047.05(h) and (i) to make the periodic quality assurance checks;

(5) The registrant shall perform periodic quality assurance checks in accordance with procedures established by the radiation therapy physicist;

(6) The registrant shall review the results of each periodic radiation output check according to the following procedures:

a. The authorized user and radiation therapy physicist shall be immediately notified if any parameter is not within its acceptable tolerance;

b. The therapeutic radiation machine shall not be made available for subsequent medical use until the radiation therapy physicist has determined that all parameters are within their acceptable tolerances;

c. If all quality assurance check parameters appear to be within their acceptable range, the quality assurance check shall be reviewed and signed by either the authorized user or radiation therapy physicist within 3 treatment days; and

d. The radiation therapy physicist shall review and sign the results of each radiation output quality assurance check at intervals not exceed 30 days;

(7) Therapeutic radiation machines subject to this section shall have safety quality assurance checks listed in “Comprehensive QA for Radiation Oncology” (1994) prepared by AAPM Radiation Therapy Committee Task Group 40, which is incorporated by reference and included in Appendix A, performed at intervals not to exceed 7 days;

(8) To satisfy the requirement of (v)(7) above, safety quality assurance checks shall ensure proper operation of:

a. Electrical interlocks at each external beam radiation therapy room entrance;

b. The “BEAM-ON”, interrupt, and termination switches;

c. Beam condition indicator lights on the access doors, control console, and in the radiation therapy room;

d. Viewing systems;

e. Electrically operated treatment room door(s) from inside and outside the treatment room; and

f. At least one emergency power cutoff switch, as follows:

1. If more than one emergency power cutoff switch is installed and not all switches are tested at once, each switch shall be tested on a rotating basis; and

2. Safety quality assurance checks of the emergency power cutoff switches may be conducted at the end of the treatment day in order to minimize possible stability problems with the therapeutic radiation machine.

(9) The registrant shall promptly repair any system identified in (v)(8) above that is not operating properly;

(10) The registrant shall maintain a record of each quality assurance check required for 3 years; and

(11) The record required in (v)(10) above shall include:

a. The date of the quality assurance check;

b. The manufacturer’s name;

c. The machine model number;

d. The machine serial number;

e. The manufacturer’s name, model number, and serial number of the instrument(s) used to measure the radiation output of the therapeutic radiation machine; and

f. The signature of the individual who performed the periodic quality assurance check.

(w) For intensity modulated radiation therapy (IMRT), quality assurance checks shall:

(1) Include commissioning and testing of the treatment planning and delivery systems, routine quality assurance of the delivery system, and patient specific validation of treatment plan;

(2) Be performed in accordance with “Guidance document on delivery, treatment planning, and clinical implementation of IMRT” (2003) Report of the IMRT subcommittee of the AAPM radiation therapy committee: AAPM Report No. 82, which is incorporated by reference and included in Appendix A;

(3) Be performed in accordance with the manufacturer’s contractual specifications.

Source. #6827, eff 8-6-98; ss by #8692, INTERIM, eff 7-27-06, EXPIRES: 2-2-07; ss by #8808, eff 1-24-07; ss by #10764, INTERIM, eff 1-23-15, EXPIRES: 7-22-15; ss by #10894, eff 7-21-15

New. #14598, INTERIM, eff 5-22-26, EXPIRES: 11-18-26

He-P 4047.08 Calibration of Survey Instruments.

(a) The registrant shall ensure that the survey instruments used to show compliance with He-P 4047 have been calibrated as follows:

(1) Before the first use;

(2) At intervals not to exceed 12 months; and

(3) Following repair.

(b) To satisfy the requirements of (a) above, the registrant shall:

(1) Calibrate all required scale readings up to 10 mSv (1000 mrem) per hour with an appropriate radiation source that is traceable to the National Institute of Standards and Technology (NIST); and

(2) Calibrate at least 2 points on each scale to be calibrated. These points shall be approximately 1/3 to 2/3 full-scale.

(1) Consider a point as calibrated if the indicated dose rate differs from the calculated dose rate by not more than 10 percent; and

(2) Consider a point as calibrated if the indicated dose rate differs from the calculated dose rate by not more than 20 percent if a correction factor or graph is conspicuously attached to the instrument.

(d) The registrant shall retain a record of each calibration required in (a) above for 3 years.

(e) The record required in (d) above shall include:

(1) A description of the calibration procedure; and

(2) A description of:

a. The source used;

b. The certified dose rates from the source;

c. The rates indicated by the instrument being calibrated;

d. The correction factors deduced from the calibration data;

e. The signature of the individual who performed the calibration; and

f. The date of calibration.

(f) The registrant may obtain the services of individuals registered or licensed by DHHS/RHS, the U.S. Nuclear Regulatory Commission, an agreement state, or a licensing state to perform calibrations of survey instruments.

Source. #6827, eff 8-6-98; ss by #8692, INTERIM, eff 7-27-06, EXPIRES: 2-2-07; ss by #8808, eff 1-24-07; ss by #10764, INTERIM, eff 1-23-15, EXPIRES: 7-22-15; ss by #10894, eff 7-21-15

New. #14598, INTERIM, eff 5-22-26, EXPIRES: 11-18-26

He-P 4047.09 Shielding and Safety Design Requirements.

(a) Each therapeutic radiation machine subject to He-P 4047.06 or He-P 4047.07 shall be provided with such primary and secondary barriers as are necessary to ensure compliance with He-P 4020.05 and He-P 4020.13.

(b) Facility design information for all new installations of a therapeutic radiation machine or installations of a therapeutic radiation machine of higher energy into a room not previously approved for that energy shall be submitted for DHHS/RHS approval prior to actual installation of the therapeutic radiation machine.

(c) The following minimum facility design information shall be submitted to DHHS/RHS with any request for the therapeutic radiation machine installation approval:

(1) For any therapeutic radiation machine, the following basic facility information:

a. Name;

b. Telephone number;

c. The DHHS/RHS registration number of the individual responsible for preparation of the shielding plan;

d. Name and telephone number of the facility supervisor;

e. The facility street address;

f. The facility room number for the therapeutic radiation machine;

g. Indication if this is a new structure or a modification to existing structure(s);

h. The primary barriers for all wall, floor, and ceiling areas struck by the useful beam;

i. All secondary barriers provided in all wall, floor, and ceiling areas not having primary barriers;

j. If commercial software is used to generate shielding requirements, the software name, version, and date of revision;

k. If the software used to generate shielding requirements is not in the open literature, quality control sample calculations to verify the result obtained with the software;

l. The structural composition and thickness or lead equivalent of all walls, doors, partitions, floor, and ceiling of the room(s) concerned;

m. The type of occupancy of all adjacent areas inclusive of space above and below the room(s) concerned, and any exterior wall(s), with distance to the closest area(s) where it is likely that individuals might be present; and

n. At least one example calculation which shows the methodology used to determine the amount of shielding required for each primary and secondary barriers, restricted and unrestricted areas, entry door(s), and shielding material in the facility.

(2) In addition to the requirements listed in (c)(1) above, therapeutic radiation machine facilities which produce only photons with a maximum energy less than or equal to 150 kV shall submit shielding plans which contain, as a minimum, the following additional information:

a. Equipment specifications, including the manufacturer and model number of the therapeutic radiation machine, as well as the maximum technique factors;

b. Maximum design workload for the facility to include:

1. Total weekly radiation output expressed in gray (rad) or air kerma at 1 meter;

2. Total beam-on time per day or week;

3. The average treatment time per patient; and

4. The anticipated number of patients to be treated per day or week; and

c. A facility blueprint or drawing indicating:

1. Scale;

2. Direction of North;

3. Normal location of the therapeutic radiation machine’s radiation port(s);

4. The port’s travel and traverse limits;

5. General direction(s) of the useful beam;

6. Locations of any windows and doors;

7. The location of the therapeutic radiation machine control panel;

8. The location of the operator’s booth if the control panel is located inside the therapeutic radiation machine treatment room; and

9. The operator’s station at the control panel has a protective barrier sufficient to ensure compliance with He-P 4020.05;

(3) In addition to the requirements listed in (c)(1) above, therapeutic radiation machine facilities that produce photons with a maximum energy in excess of 150 kV or electrons shall submit shielding plans which contain, as a minimum, the following additional information:

a. Equipment specifications to include:

1. The manufacturer;

2. The model number of the therapeutic radiation machine;

3. The gray or rad at the isocenter;

4. The energy(s) and type(s) of radiation produced; and

5. The target to isocenter distance;

b. Maximum design workload for the facility including:

1. Total weekly radiation output expressed in gray rad at 1 meter;

2. Total beam-on time per day or week;

3. The average treatment time per patient; and

4. The anticipated number of patients to be treated per day or week;

c. Facility blueprint or drawing indicating:

1. The floor plan and elevation views each indicating relative orientation of the therapeutic radiation machine;

2. Type(s), thickness, and minimum density of shielding material(s);

3. Direction of North; and

4. The locations and size of all beam penetrations through each ceiling, wall, floor, details of the door(s) and maze shielding barrier; and

d. A description of all assumptions that were in the shielding calculations including, but not limited to:

1. Design energy;

2. Work-load;

3. Presence of integral beam-stop in unit;

4. Occupancy and use(s) of adjacent areas;

5. Fraction of time that useful beam will intercept each permanent barrier for all walls, floor, and ceiling; and

6. Shielding design goal for radiation exposure in both restricted and unrestricted areas.

(4) In addition to the requirements listed in (c)(3) above, therapeutic radiation machine facilities which are capable of operating above 10 MV shall submit shielding plans which contain, as minimum, the following additional information:

a. The structural composition, thickness, minimum density, and location of all neutron shielding material;

b. Description of all assumptions that were used in neutron shielding calculations including, but not limited to;

1. Neutron spectra as a function of energy;

2. Neutron fluence rate; and

3. Absorbed dose and dose equivalent for neutrons in both restricted and unrestricted areas;

c. At least one example calculation which shows the methodology used to determine the amount of neutron shielding required for each restricted and unrestricted areas, entry door(s), maze, and the neutron shielding material utilized in the facility; and

d. The method(s) and instrumentation which will be used to verify the adequacy of all neutron shielding installed in the facility.

Source. #6827, eff 8-6-98; ss by #8692, INTERIM, eff 7-27-06, EXPIRES: 2-2-07; ss by #8808, eff 1-24-07; ss by #10764, INTERIM, eff 1-23-15, EXPIRES: 7-22-15; ss by #10894, eff 7-21-15

New. #14598, INTERIM, eff 5-22-26, EXPIRES: 11-18-26

He-P 4047.10 Quality Assurance For Radiation Therapy Simulation Systems. Quality assurance for a conventional or virtual simulator shall include:

(a) Acceptance testing;

(b) Periodic verification of system performance;

(c) Be performed in accordance with “Comprehensive QA for Radiation Oncology,” (Updated by Table II)(1994) prepared by American Association of Physicists in Medicine (AAPM), Radiation Therapy Committee Task Group No. 40; or

(d) Be performed in accordance with “Quality Assurance for Computed –Tomography Simulators and the Computed Tomography-Simulation Process” (2003) prepared by AAPM Radiation Therapy Committee Task Group 66 as incorporated by reference and included in Appendix A.

Source. #10894, eff 7-21-15

New. #14598, INTERIM, eff 5-22-26, EXPIRES: 11-18-26

He-P 4047.11 Electronic Brachytherapy.

(a) Electronic brachytherapy devices shall be subject to the requirements of this section and shall be exempt from the requirements of He-P 4047.06, and which are:

(1) An electronic brachytherapy device that does not meet the requirements of this section shall not be used for irradiation of patients; and

(2) An electronic brachytherapy device shall only be utilized for human use applications specifically approved by the U.S. Food and Drug Administration (FDA) unless participating in a research study approved by the registrant’s institutional review board.

(b) Each facility location authorized to use an electronic brachytherapy device shall possess appropriately calibrated portable monitoring equipment which shall as a minimum:

(1) Include a portable radiation measurement survey instrument capable of measuring dose rate over the range of 10 µSv (1 mrem) per hour to 10 mSv (1000 mrem) per hour, and

(2) Be operable and calibrated in accordance with He-P 4047.08 for the applicable electronic brachytherapy source energy.

(c) In addition to shielding adequate to meet the requirements of He-P 4047.09, the treatment room shall meet the following design requirements:

(1) If applicable, provision shall be made to prevent simultaneous operation of more than one therapeutic radiation machine in a treatment room;

(2) Access to the treatment room shall be controlled by a door at each entrance;

(3) Each treatment room shall have provisions to permit continuous aural communication and visual observation of the patient from the treatment control panel during irradiation;

(4) The electronic brachytherapy device shall not be used for patient irradiation unless the patient can be observed;

(5) For electronic brachytherapy devices capable of operating below 50kV, radiation shielding for the staff in the room shall be available:

a. Either as a portable shield; or

b. As localized shielded material around the treatment site; and

(6) For electronic brachytherapy devices capable of operating at greater than 150 kV;

a. The control panel shall be located outside the treatment room; and

b. Electrical interlocks shall be provided for all door(s) to the treatment room that will:

1. Prevent the operator from initiating the treatment cycle unless each treatment room entrance door is closed;

2. Cause the source to be shielded when an entrance door is opened; and

3. Prevent the source from being exposed following an interlock interruption until all treatment room entrance doors are closed and the source on-off control is reset at the console.

(d) Each electronic brachytherapy device shall have the following electrical safety features:

(1) The high voltage transformer shall be electronically isolated to prevent electrical and magnetic interference with the surrounding environment and ancillary equipment;

(2) The high voltage transformer shall be isolated from personnel and the environment by a protective housing that can only be accessed through a cover requiring a tool for access or with electrical interlocks to prevent operation while open;

(3) The high voltage transformer shall have appropriate safety labels warning personnel of potential electrical shock and or heat related injuries; and

(4) Equipment manufactured shall be in compliance with the most current revision of the following International Electrotechnical Commission (IEC) Documents which are incorporated by reference and included in Appendix A:

a. IEC 60601-1:1988/AMD2:1995

b. IEC 60601-1-2:2001;

c. IEC 60601-2-8:1999; and

d. IEC 60601-2-17:2004.

(e) The control panel in addition to the displays required by other provisions in this section, shall:

(1) Provide an indication of whether electrical power is available at the control panel and if activation of the electronic brachytherapy source is possible;

(2) Provide an indication of whether x-rays are being produced;

(3) Provide a means for indicating electronic brachytherapy source potential and current;

(4) Provide the means for terminating an exposure at any time; and

(5) Include an access control system that will prevent unauthorized use of the electronic brachytherapy device.

(f) A suitable irradiation control device or timer shall be provided to terminate the irradiation after a preset time interval or integrated charge on a dosimeter-based monitor. Timers shall:

(1) Be provided at the control panel and shall indicate planned setting and the time elapsed or remaining;

(2) Not permit an exposure if set at zero;

(3) Be a cumulative device that activates with an indication of “BEAM On” and retains its reading after irradiation is interrupted or terminated. After irradiation is terminated and before irradiation can be reinstated, it shall be necessary to reset the elapsed time indicator;

(4) Terminate irradiation when a pre-selected time has elapsed, if any dose monitoring system has not previously terminated irradiation;

(5) Permit setting of exposure times as short as 0.1 seconds; and

(6) Be accurate to within 1 percent of the selected value or 0.1 seconds, whichever is greater.

(g) The services of a radiation therapy physicist shall be required in facilities having electronic brachytherapy devices. The radiation therapy physicist shall be responsible for:

(1) Evaluation of the output from the electronic brachytherapy source;

(2) Generation of the necessary dosimetric information;

(3) Supervision and review of treatment calculations prior to initial treatment of any treatment site:

(4) Establishing the periodic and day-of-use quality assurance checks and reviewing the data from those checks as required in (j) below;

(5) Consultation with the authorized user in treatment planning, as needed;

(6) Performing calculations and assessments regarding patient treatments that may constitute a misadministration; and

(7) Determining which persons in the treatment room require monitoring when the beam is energized.

(h) Operating procedures shall be as follows:

(1) Only individuals approved by the authorized user, radiation safety officer, or radiation therapy physicist shall be present in the treatment room during treatment;

(2) Electronic brachytherapy devices shall not be made available for medical use unless the requirements of He-P 4047.04(a), and (i) through (k) below have been met;

(3) The electronic brachytherapy device shall be secured to prevent unauthorized use;

(4) During operation, the electronic brachytherapy device operator shall monitor the position of all persons in the treatment room, and all persons entering the treatment room, to prevent entering persons from unshielded exposure from the treatment beam;

(5) If a patient must be held in position during treatment, mechanical supporting or restraining devices shall be used;

(6) Written procedures shall be developed, implemented, and maintained for responding to an abnormal situation. These procedures shall include:

a. Instructions for responding to equipment failures and the names of the individuals responsible for implementing corrective actions; and

b. The names and telephone numbers of the authorized users, radiation safety officer, and the radiation therapy physicist to be contacted if the device or console operates abnormally;

(7) A copy of the current operating and emergency procedures shall be maintained at the control console or panel during electronic brachytherapy device operation. If the console is integral to the electronic brachytherapy device, the required procedures shall be kept where the operator is located during electronic brachytherapy device operation;

(8) Instructions shall be posted at the electronic brachytherapy device control console to inform the operator of the names and telephone numbers of the authorized users, the radiation safety officer, and the radiation therapy physicist to be contacted if the device or console operates abnormally;

(9) The radiation safety officer, and an authorized user shall be notified as soon as possible if the patient has medical emergency, suffers injury, or dies. The radiation safety officer or radiation therapy physicist shall inform the manufacturer of the event;

(10) If the radiation therapy physicist is not a full time employee of the registrant, the operating procedures, required in this paragraph shall also specifically address how the radiation therapy physicist is to be contacted for problems or emergencies, as well as the specific actions, if any, to be taken until the radiation therapy physicist can be contacted.

(i) Calibration procedures shall include:

(1) Calibration of the electronic brachytherapy source output shall be made for each electronic brachytherapy source, or after any repair affecting the x-ray beam generation, or when indicated by the electronic brachytherapy source quality assurance checks;

(2) Calibration of electronic brachytherapy source output shall utilize a dosimetry system described in He- 4047.05(h);

(3) Calibration of electronic brachytherapy source output shall include, as applicable, determination of:

a. The output within 2 percent of the expected value, if applicable, or determination of the output if there is no expected value;

b. Timer accuracy and linearity over the typical range of use;

c. Proper operation of back exposure control device;

d. Evaluation that the relative dose distribution about the source is within 5 percent of that expected; and

e. Source positioning accuracy within 1 millimeter of the applicator;

(4) Calibration of the x-ray source output required in by (i) above, shall be in accordance with current published recommendations from a recognized national professional association with expertise in electronic brachytherapy, and if that published recommendation is not available, then from the manufacturer’s suggested calibration protocol; and

(5) The registrant shall maintain a record of each calibration in an auditable form for the duration of registration. The record shall include:

a. The date of the calibration;

b. The manufacturer’s name;

c. The model number and serial number for the electronic brachytherapy device;

d. A unique identifier for its electronic brachytherapy source;

e. The model numbers and serial numbers of the instrument(s) used to calibrate the electronic brachytherapy device; and

f. The name and signature of the radiation therapy physicist responsible for performing the calibration.

(j) Quality assurance checks shall be conducted as follows:

(1) Quality assurance checks shall be performed on each electronic brachytherapy device subject to this section:

a. At the beginning of each day of use;

b. Each time the device is moved to a new room or site, including each day of use at each operating location; and

c. After each x-ray tube installation;

(2) The registrant shall perform periodic quality assurance checks required by (j)(1) above in accordance with procedures established by the radiation therapy physicist;

(3) To satisfy the requirements of (j)(1) above, radiation output quality assurance checks shall include as a minimum:

a. Verification that output of the electronic brachytherapy source falls within 3 percent of expected values, as appropriate for the device, as determined by:

1. Output as a function of time; or

2. Output as a function of setting on a monitor chamber;

b. Verification of the consistency of the dose distribution to within 3 percent of that found during calibration required by (i) above; and

c. Validation of the operation of positioning methods to ensure that the treatment dose exposes the intended location within one mm;

(4) The registrant shall use a dosimetry system that has been intercompared within the previous 12 months with the dosimetry system described in He-P 4047.05(h) to make the quality assurance checks required in He-P (j)(3) above;

(5) The registrant shall review the results of each radiation output quality assurance check according to the following procedures:

a. An authorized user and radiation therapy physicist shall be immediately notified if any parameter is not within its acceptable tolerance. The electronic brachytherapy device shall not be made available for subsequent medical use until the radiation therapy physicist has determined that all parameters are within their acceptable tolerances;

b. If all radiation output quality assurance check parameters appear to be within their acceptable range, the quality assurance check shall be reviewed and signed by either the authorized user or radiation therapy physicist within 2 business days; and

c. The radiation therapy physicist shall review and sign the results of each radiation output quality assurance check at intervals not to exceed 30 days;

(6) To satisfy the requirement (i)(1) above, safety device quality assurance checks shall at a minimum assure:

a. Proper operation of radiation exposure indicator lights on the electronic brachytherapy device and on the control console;

b. Proper operation of viewing and intercom systems in each electronic brachytherapy facility, if applicable;

c. Proper operation of radiation monitors, if applicable;

d. The integrity of all cables, catheters, or parts of the device that carry high voltages; and

e. Connecting guide tubes, transfer tubes, transfer-tube applicator interfaces, and treatment spacers are free from any defects that interfere with proper operation;

(7) If the results of the safety device quality assurance checks required in (j)(6) above indicate the malfunction of any system, a registrant shall secure the control console in the OFF position and not use the electronic brachytherapy device except as might be necessary to repair, replace, or check the malfunctioning system; and

(8) The registrant shall maintain a record of each quality assurance check required by (j)(3) and (j)(6) above in an auditable form for 3 years as follows:

a. The record shall include:

1. Date of the quality assurance check;

2. Manufacturer’s name, model number, and serial number for the electronic brachytherapy device;

3. Name and signature of the individual who performed the periodic quality assurance check; and

4. Name and signature of the radiation therapy physicist who reviewed the quality assurance check; and

b. For radiation output quality assurance checks required by (j)(3) above, the record shall also include:

1. The unique identifier for the electronic brachytherapy source; and

2. The manufacturer’s name, model number, and serial number for the instrument(s) used to measure the radiation output of the electronic brachytherapy device.

(k) The registrant shall perform acceptance testing on the treatment planning system of electronic brachytherapy-related computer systems in accordance with current published recommendations from a recognized national professional association with expertise in electronic brachytherapy, when available. In the absence of an acceptance testing protocol published by a national professional association, the manufacturer’s acceptance testing protocol shall be followed. All acceptance testing shall:

(1) Be performed by, or under the direct supervision of, a radiation therapy physicist; and

(2) At a minimum, acceptance testing shall include as applicable, verification of:

a. The source-specific input parameters required by the dose calculation algorithm;

b. The accuracy of dose, dwell time, and treatment time calculations at representative points;

c. The accuracy of isodose plots and graphic displays;

d. The accuracy of the software used to determine radiation source positions from radiographic images; and

e. If the treatment-planning system is different from the treatment-delivery system, the accuracy of electronic transfer of the treatment delivery parameters to the treatment delivery unit from the treatment planning system;

(3) Compare the position indicators in the applicator to the actual position of the source or planned dwell positions, as appropriate, at a time of commissioning; and

(4) Include procedures prior to each patient treatment regimen, for the parameters for the treatment to be evaluated and approved by the authorized user and the radiation therapy physicist for correctness through means independent of that used for the determination of the parameters.

(l) The following training shall be required:

(1) A registrant shall provide instruction, initially and at least annually, to all individuals who operate the electronic brachytherapy device, as appropriate to the individual’s assigned duties, in the operating procedures identified in (h) above. If the interval between patients exceeds one year, retraining of the individuals shall be provided;

(2) In addition to the requirements of He-P 4047.04(e) for the therapeutic radiation machine authorized users and He-P 4047.04(k) for radiation therapy physicists, these individuals shall also receive device specific instruction initially from the manufacturer, and annually from either the manufacturer or other authorized manufacturer qualified trainer. The training shall be of a duration recommended by a recognized national professional association with expertise in electronic brachytherapy, when available. In the absence of any training protocol recommended by a national professional association, the manufacturer’s training protocol shall be followed. The training shall include, but not be limited to:

a. Device-specific radiation safety requirements;

b. Device operation;

c. Clinical use for the types of use approved by the FDA;

d. Emergency procedures, including an emergency drill; and

e. The registrant’s quality assurance program; and

(3) A registrant shall retain a record of individuals receiving instruction required by (l)(1) and (2) above for 3 years. The record shall include:

a. A list of the topics covered;

b. The date of the instruction;

c. The name(s) of the attendee(s); and

d. The name(s) of the individual(s) who provided the instruction.

(m) A registrant providing mobile electronic brachytherapy service shall as a minimum:

(1) Check all survey instruments before medical use at each address of use or on each day of use, whichever is more restrictive;

(2) Account for the electronic brachytherapy source in the electronic brachytherapy device before departure from the client’s address; and

(3) Perform, at each location on each day of use, all of the required quality assurance checks specified in He-P 4047.11(j) to assure proper operation of the device.

Source. #10894, eff 7-21-15

New. #14598, INTERIM, eff 5-22-26, EXPIRES: 11-18-26

He-P 4047.12 Other Use of Electronically-Produced Radiation to Deliver Therapeutic Radiation Dosage. A person shall not utilize any device which is designed to electrically generate a source of ionizing radiation to deliver therapeutic radiation dosage, and which is not appropriately regulated under any existing category of therapeutic radiation machine, until:

(a) The applicant or registrant has, at a minimum, provided DHHS/RHS with:

(1) A detailed description of the device and its intended application(s):

(2) Facility design requirements, including shielding and access control;

(3) Documentation of appropriate training for authorized user physician(s) and radiation therapy physicist(s);

(4) Methodology for measurement of dosages to be administered to patients or human research subjects;

(5) Documentation regarding calibration, maintenance, and repair of the device, as well as instruments and equipment necessary for radiation safety;

(6) Radiation safety precautions and instructions; and

(7) Other information requested by DHHS/RHS in its review of the application.

(b) The applicant or registrant has received approval from DHHS/RHS to utilize the device in accordance with the regulations and specific conditions DHHS/RHS considers necessary for the medical use of the device.

Source. #10894, eff 7-21-15

New. #14598, INTERIM, eff 5-22-26, EXPIRES: 11-18-26

PARTS He-P 4048 – He-P 4061 Reserved