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;

 

(c)  The process for the registration of magnetic resonance imaging (MRI) 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;

 

(c)  Who offers radiation or MRI machine servicing or services; or

 

(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 31st 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.

 

(c)  Domestic television receivers and video display terminals shall be exempt from the 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.

 

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)

 

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.

 

(c)  The applicant shall specify each applicable type of service being offered, choosing from the following:

 

(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 1st 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 1st 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 type of 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.

 

(c)  Any person who wishes to request a waiver shall submit a written request for a waiver.

 

(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

 

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 a similar compatible component 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 table top             cassette holder.

 

(c)  “Added filtration” means any filtration which is in addition to the inherent filtration.

 

(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 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).

 

(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, having dimensions 20 centimeters by 20 centimeters by 3.8 centimeters, of type 1100 aluminum alloy or other materials having equivalent attenuation.

 

(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” mean 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;

 

= The ith observation in sample; and

 

n = Number of observations in sample.

 

(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)  “Cone beam computed tomography (CBCT)” means a digital volume tomography method used in some imaging applications using two 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.

 

(ag)  “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.

 

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

 

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

         

 

where:

 

μx = Linear attenuation coefficient of the material of interest;

 

μw = Linear attenuation coefficient of water;

 

CTNx= CTN of the material of interest; and

 

CTNw= CTN of water.

 

(aj)  “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.

 

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

 

(al)  “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(cy).

 

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

 

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

 

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

 

CTN

where:

 

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

 

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

 

μw = Linear attenuation coefficient of water.

 

(ap)  “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.

 

(aq)  “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.

 

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

 

(as)  “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. 

 

(at)  “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.

 

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

 

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

 

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

 

(ax)  “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.

 

(ay)  “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.

 

(az)  “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.

 

(ba)  “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.

 

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

 

(bc)  “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).

 

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

 

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

 

(bf)  “Entrance exposure rate” means the exposure in air per unit time at the point where the center of the useful beam enters the patient.

 

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

 

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

 

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

 

(bj) “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.

 

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

 

(bl) “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.

 

(bm) “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.

 

(bn) “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.

 

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

 

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

 

(bq)  “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.

 

(br)  “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.

 

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

 

(bt)  “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.

 

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

 

(bv) “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.

 

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

 

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

 

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

 

(bz)  “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.

 

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

 

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

 

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

 

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

 

(ce)  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.

 

(cf)  Kerma” means the quantity as defined by the International Commission on Radiation Units and Measurements.  The kerma, K, is the quotient of dEtr by dm, where dEtr 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=dEtr/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.”

 

(cg)  “Kilovolts peak (kVp)” means “peak tube potential” as defined in He-P 4041.02(de).

 

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

 

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

 

(cj)  “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.

 

(ck) “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.

 

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

 

(cm) “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.

 

(cn) “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;

 

(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; or

 

(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.

 

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

 

(cp)  “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.

 

(cq)  “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:

 

VN = No-load line potential; and

 

VL = Load line potential.

 

(cr)  “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.

 

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

 

(ct)  “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.

 

(cu)  “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.

 

(cv)  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.”

 

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

 

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

 

(cy)  “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.”

 

(cz)  “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.

 

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

 

(db)  “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.

 

(dc)  “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 as defined in He-P 4041.02(t);

 

μw = Linear attenuation coefficient of water; and

 

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

 

(dd)  “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.

 

(de)  “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.

 

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

 

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

 

(dh)  “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.

 

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

 

(dj)  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.

 

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

 

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

 

(dm)  “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.

 

(dn)  “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.

 

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

 

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

 

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

 

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

 

(ds)  “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.

 

(dt)  “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.

 

(du)  “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.

 

(dv)  “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.

 

(dw)  “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.

 

(dx)  “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.

 

(dy)  “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.

 

(dz)  “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.

 

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

 

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

 

(ec)  “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 two 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)  “Security screening system” means a non-medical use screening system designed for the detection of contraband and weapons concealed on a person or in a vehicle while being occupied by one or more people.

 

(eq)  “Security screening system” means a non-medical use screening system designed for the detection of contraband and weapons concealed on a person or in a vehicle while being occupied by one or more people.

 

(er)  “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.

 

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

 

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

 

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

 

(ev)  “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.

 

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

 

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

 

(ey)  “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. 

 

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

 

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

 

(fb)  “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.

 

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

 

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

 

(fe)  “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.

 

(ff)  “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.

 

(fg)  “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. 

 

(fh)  “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.

 

(fi)  “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.

 

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

 

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

 

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

 

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

 

(fn)  “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.

 

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

 

(fp)  “Useful beam” means the radiation emanating from the tube housing port or the radiation head and passing through the aperture of the beam limiting device when the exposure controls are in a mode to cause the system to produce radiation.

 

(fq)  “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.

 

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

 

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

 

(ft)  “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.

 

(fu)  “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.

 

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

 

(fw)  “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.

 

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

 

(fy)  “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.

 

(fz)  “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.

 

(ga)  “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.

 

(gb)  “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.

 

(gc)  “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.

 

(gd)  “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

 

PART He-P 4042 - RESERVED

 

PART He-P 4043  RADIATION SAFETY REQUIREMENTS FOR ANALYTICAL X-RAY EQUIPMENT

 

He-P 4043.01  Purpose.  This part provides special requirements for analytical x-ray equipment.

 

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

 

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

 

He-P 4043.03  Definitions.

 

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

 

(b) “Analytical x-ray system” means a group of components utilizing x-rays to determine the elemental composition or to examine the microstructure of materials.

 

(c)  “Fail-safe characteristics” mean a design feature which causes beam port shutters to close, or otherwise prevents emergence of the primary beam, upon the failure of a safety or warning device.

 

(d)  “Fixed gauge” means devices that are installed by design to monitor/measure the level of the contents of vessels or tanks.

 

(e)  “Hybrid gauge” means a gauging device utilizing both x-ray and radioactive material sources.

 

(f)  “Local components” mean part of an analytical x-ray system and include 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.

 

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

 

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

 

(i)  “Primary beam” means ionizing radiation which passes through an aperture of the source housing by a direct path from the x-ray tube or a radioactive source located in the radiation source housing.

 

(j)  “Safety device” means a 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. 

 

(k)  “Scanning Electron Microscope (SEM)” 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.”

 

(l)  “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

 

          He-P 4043.04  Equipment Requirements.

 

(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)  DHHS/RHS may grant an exemption from the requirement of a safety device for open-beam configurations if the registrant submits an application requesting such exemptions, and:

 

(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.

 

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

 

(d)  The warning device required in He-P 4043.04(c) shall:

 

(1)  Indicate the x-ray tube “on-off” status and be located near the radiation source housing, if the primary beam is controlled in this manner; or

 

(2)  Indicate the shutter “open-closed” status and be located near each port on the radiation source housing, if the primary beam is controlled in this manner.

 

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

 

(f)  The warning light required in He-P 4043.04(e) shall be illuminated only when the x-ray tube is energized.

 

(g)  For a radioactive source contained in an analytical device, a warning light shall be located near any switch that opens a housing shutter.

 

(h)  The warning light required in He-P 4043.04(e), (f) and (g) shall be illuminated only when the shutter is open.

 

(i)  Warning devices shall be labeled so that their purpose is easily identified.

 

(j)  Warning devices shall have fail-safe characteristics.

 

(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)  All analytical x-ray equipment shall be labeled with a readily discernable sign(s) bearing the radiation symbol and the words:

 

(1)  “CAUTION - HIGH INTENSITY X-RAY BEAM” on the x-ray source housing on one sign, and “CAUTION RADIATION - THIS EQUIPMENT PRODUCES RADIATION WHEN ENERGIZED” near any switch that energizes an x-ray tube if the radiation source is an x-ray tube on another sign; or

 

(2)  “CAUTION - RADIOACTIVE MATERIAL” on the source housing in accordance with He-P 4020.07, if the radiation source is a radionuclide.

 

(m)  All open-beam configurations shall be equipped with a shutter at each port on the radiation source housing so the shutter cannot be opened unless a collimator or a coupling has been connected to the port.

 

(n)  Each radiation machine source housing shall be equipped with an interlock that shuts off the tube if the tube is removed from the radiation source housing or if the housing is disassembled.

 

(o)  Each radioactive source housing or port cover or each x-ray tube housing shall be so constructed that, with all shutters closed, the radiation measured at a distance of 5 centimeters from the source housing or for x-ray tubes at any specified tube rating is not capable of producing a dose in excess of 2.5 millirems (0.025 mSv) in one hour.

 

(p)  Each x-ray generator shall be supplied with a protective cabinet which limits leakage radiation measured at a distance of 5 centimeters from its surface such that it is not capable of producing a dose in excess of 0.25 millirem (2.5 μSv) in one hour.

 

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

 

He-P 4043.05  Area Requirements.

 

(a)  The local components of an analytical x-ray system shall be located and arranged and include sufficient shielding or access control such that no radiation levels exist in any area surrounding the local component group which result in a dose to an individual present therein in excess of the dose limits given in He-P 4020.

 

(b)  For systems utilizing x-ray tubes, the requirements specified in He-P 4043.05(a) shall be met at any specified tube rating.

 

(c)  Radiation surveys, as required by He-P 4022.01, of all analytical x-ray systems sufficient to show compliance with He-P 4043.05(a) 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 or removal of a local component in the system;

 

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

 

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

 

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

 

(d)  Radiation survey measurements shall not be required if a registrant or licensee can demonstrate compliance with He-P 4043.05(a) to the satisfaction of DHHS/RHS.

 

(e)  Each area or room containing analytical x-ray equipment shall be conspicuously posted with a sign or signs bearing the radiation symbol and the words “CAUTION - X-RAY EQUIPMENT” in accordance with He-P 4022.11.

 

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

 

He-P 4043.06  Operating Requirements.

 

(a)  Normal and emergency operating procedures shall be written and available to all analytical x-ray equipment workers.

 

(b)  These procedures shall include:

 

(1)  Sample insertion and manipulation;

 

(2)  Equipment alignment;

 

(3)  Routine maintenance procedures to be performed by the registrant; and

 

(4)  Data recording procedures, which are related to radiation safety.

 

(c)  No individual shall be permitted to operate analytical x-ray equipment in any manner other than that specified in the procedures unless such individual has obtained written approval of the radiation safety officer.

 

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

 

(e)  The written approval required in He-P 4043.06(c) and (d) shall be for a specified period of time.

 

(f)  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.

 

(g)  Except as specified in He-P 4043.06(c), (d), (e), and (f), 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.

 

(h)  The main switch, rather than interlocks, shall be used for routine shutdown in preparation for repair as specified in He-P 4043.06(g).

 

(i)  Radioactive source housings shall be opened for source replacement, leak testing, or other maintenance or repair procedures only by individuals authorized to specifically conduct such procedures under a license issued by DHHS/RHS, the U.S. Nuclear Regulatory Commission (NRC), an Agreement State, or a Licensing State.

 

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

 

He-P 4043.07  Personnel Requirements.

 

(a)  No individual shall be permitted to operate or maintain analytical x-ray equipment unless such individual has received instruction and demonstrated competence as to:

 

(1)  Identification of radiation hazards associated with the use of the equipment;

 

(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)  Proper operating procedures for the equipment;

 

(5)  Recognition of symptoms of an acute localized exposure; and

 

(6)  Proper procedures for reporting an actual or suspected exposure.

 

(b)  Any individual using analytical x-ray equipment having an open-beam configuration and not equipped with a safety device shall be provided with finger or wrist dosimetric devices.

 

(c)  Personnel maintaining analytical x-ray equipment shall be provided with finger or wrist dosimetric devices 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.

 

(d)  Reported dose values shall not be used for the purpose of determining compliance with He-P 4020.05 unless evaluated by a qualified expert.

 

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

 

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

 

He-P 4044.02  Scope.  In addition to the requirements of He-P 4044:

 

(a)  All registrants are subject to the requirements of He-P 4001, He-P 4003, He-P 4019 through He-P 4022, and He-P 4040;

 

(b)  Registrants engaged in industrial radiographic operations are subject to the requirements of He-P 4034;

 

(c)  Registrants engaged in the healing arts are subject to the requirements of He-P 4041, He-P 4035, and He-P 4045 through He-P 4047; and

 

(d)  Registrants whose operations result in the production of radioactive material are subject to the requirements of He-P 4030.

 

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

 

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

 

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;

 

(c)  The issuance of the registration will not be inimical to the health and safety of the public;

 

(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

 

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

 

(c)  The individual designated on the application as the user is a physician.

 

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

 

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

 

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

 

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

 

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

 

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 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 after having notified the radiation safety committee of such action;

 

(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

 

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)  An area monitor which has been 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)  An area survey which is 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

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

 

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 and non-medical security screening system 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:

 

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 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, 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)  Gonad shielding of not less than 0.5 millimeter lead equivalent material shall be used for patients, who have not passed the reproductive age, 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 are involved with radiation machine operations and are 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 are 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

 

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;

 

(c)  Records of calibrations, maintenance, and modifications performed on the x-ray system(s); and

 

(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;

 

(c)  Means shall be provided to permit further limitation of the field;

 

(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.