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Utah Administrative Code (Current through November 1, 2019) |
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R313. Environmental Quality, Waste Management and Radiation Control, Radiation |
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R313-35. Requirements for X-Ray Equipment Used for Non-Medical Applications |
| R313-35-1. Purpose and Scope |
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(1) R313-35 establishes radiation safety requirements for registrants who use electronic sources of radiation for industrial radiographic applications, analytical applications or other non-medical applications. Registrants engaged in the production of radioactive material are also subject to the requirements of R313-19 and R313-22. The requirements of R313-35 are an addition to, and not a substitution for, the requirements of R313-15, R313-16, R313-18 and R313-70. (2) The rules set forth herein are adopted pursuant to the provisions of Sections 19-3-104(3) and 19-3-104(6). |
| R313-35-2. Definitions |
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As used in R313-35: "Analytical x-ray system" means a group of components utilizing x-rays to determine the elemental composition or to examine the microstructure of materials by either x-ray fluorescence or diffraction analysis. "Cabinet x-ray system" means an x-ray system with the x-ray tube installed in an enclosure, hereinafter termed "cabinet," which, independent of existing architectural structure except the floor on which it may be placed, is intended to contain at least that portion of a material being irradiated, provide radiation attenuation, and exclude personnel from its interior during generation of x-radiation. Included are all x-ray systems designed primarily for the inspection of carry-on baggage at airline, railroad and bus terminals, and similar facilities. An x-ray tube used within a shielded part of a building, or x-ray equipment which may temporarily or occasionally incorporate portable shielding is not considered a cabinet x-ray system. "Collimator" means a device used to limit the size, shape and direction of the primary radiation beam. "Direct reading dosimeter" means an ion-chamber pocket dosimeter or an electronic personal dosimeter. "External surface" means the outside surfaces of cabinet x-ray systems, including the high-voltage generator, doors, access panels, latches, control knobs, and other permanently mounted hardware and including the plane across an aperture or port. "Fail-safe characteristics" means design features which cause beam port shutters to close, or otherwise prevent emergence of the primary beam, upon the failure of a safety or warning device. "Forensics x-ray" means the use of x-ray systems in forensic autopsies of deceased humans, police agency use of x-ray systems for evidence identification and testing, or x-ray system use for arson or questionable origin fire investigations. "Nondestructive testing" means the examination of the macroscopic structure of materials by nondestructive methods utilizing x-ray sources of radiation. "Non-medical applications" means uses of x-ray systems except those used for providing diagnostic information or therapy on human patients. "Normal operating procedures" means instructions necessary to accomplish the x-ray procedure being performed. These procedures shall include positioning of the equipment and the object being examined, equipment alignment, routine maintenance by the registrant, and data recording procedures which are related to radiation safety. "Open-beam configuration" means a mode of operation of an analytical x-ray system in which individuals could accidentally place some part of the body into the primary beam during normal operation if no further safety devices are incorporated. "Portable package inspection system" means a portable x-ray system designed and used for determining the presence of explosives in a package. "Primary beam" means ionizing radiation which passes through an aperture of the source housing via a direct path from the x-ray tube located in the radiation source housing. "Very high radiation area" means an area, accessible to individuals, in which radiation levels could result in individuals receiving an absorbed dose in excess of five Gy (500 rad) in one hour at one meter from a source of radiation or from any surface that the radiation penetrates. At very high doses received at high dose rates, units of absorbed dose, gray and rad, are appropriate, rather than units of dose equivalent, sievert and rem. "X-ray system" means an assemblage of components for the controlled production of x-rays. It includes, minimally, an x-ray high-voltage generator, an x-ray control, a tube housing assembly, and the necessary supporting structures. Additional components which function with the system are considered integral parts of the system. |
| R313-35-20. Personnel Monitoring |
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Registrants using x-ray systems in non-medical applications shall meet the requirements of R313-15-502. |
| R313-35-30. Locking of X-ray Systems Other Than Veterinary X-Ray Systems |
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The control panel of x-ray systems located in uncontrolled areas shall be equipped with a locking device that will prevent the unauthorized use of a x-ray system or the accidental production of radiation. Non-cabinet x-ray systems shall be kept locked with the key removed when not in use. |
| R313-35-40. Storage Precautions |
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X-ray systems shall be secured to prevent tampering or removal by unauthorized personnel. |
| R313-35-50. Training Requirements |
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In addition to the requirements of R313-18-12, an individual operating x-ray systems for non-medical applications shall be trained in the operating procedures for the x-ray system and the emergency procedures related to radiation safety for the facility. Records of training shall be made and maintained for three years after the termination date of the individual. |
| R313-35-60. Surveys |
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In addition to the requirements of R313-15-501, radiation surveys of x-ray systems shall be performed: (1) upon installation of the x-ray system; and (2) following change to or maintenance of components of an x-ray system which effect the output, collimation, or shielding effectiveness. |
| R313-35-70. Radiation Survey Instruments |
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Survey instruments used in determining compliance with R313-15 and R313-35 shall meet the following requirements: (1) Instrumentation shall be capable of measuring a range from 0.02 millisieverts (2 millirem) per hour through 0.01 sievert (1 rem) per hour. (2) Instrumentation shall be calibrated at intervals not to exceed 12 months and after instrument servicing, except for battery changes. (3) For linear scale instruments, calibration shall be shown at two points located approximately one-third and two-thirds of full-scale on each scale. For logarithmic scale instruments, calibration shall be shown at mid-range of each decade, and at two points of at least one decade. For digital instruments, calibration shall be shown at three points between 0.02 and 10 millisieverts (2 and 1000 millirems) per hour. (4) An accuracy of plus or minus 20 percent of the calibration source shall be demonstrated for each point checked pursuant to R313-35-70(3). (5) The registrant shall perform visual and operability checks of survey instruments before use on each day the survey instrument is to be used to ensure that the equipment is in good working condition. If survey instrument problems are found, the equipment shall be removed from service until repaired. (6) Results of the instrument calibrations showing compliance with R313-35-70(3) and R313-35-70(4) shall be recorded and maintained for a period of three years from the date the record is made. (7) Records demonstrating compliance with R313-35-70(5) shall be made when a problem is found. The records shall be maintained for a period of three years from the date the record is made. |
| R313-35-80. Cabinet X-ray Systems |
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(1) The requirements as found in 21 CFR 1020.40, 1996 ed., are adopted and incorporated by reference. (2) Individuals operating cabinet x-ray systems with conveyor belts shall be able to observe the entry port from the operator's position. |
| R313-35-90. Portable Package Inspection Systems |
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Portable package inspection systems shall be registered in accordance with R313-16 and shall be exempt from inspection by representatives of the Director. |
| R313-35-100. Analytical X-Ray Systems Excluding Cabinet X-Ray Systems |
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(1) Equipment. Analytical x-ray systems not contained in cabinet x-ray systems shall meet all the following requirements. (a) A device which prevents the entry of portions 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, shall be provided for open-beam configurations. (i) Pursuant to R313-12-55(1), an application for an exemption from R313-35-100(1)(a) shall contain the following information: (A) a description of the various safety devices that have been evaluated; (B) the reason that these devices cannot be used; and (C) a description of the alternative methods that will be employed to minimize the possibility of an accidental exposure, including procedures to assure that operators and others in the area will be informed of the absence of safety devices. (ii) applications for exemptions to R313-35-100(1)(a) shall be submitted to the Director. (b) Open-beam configurations shall be provided with a readily discernible indication of: (i) the "on" or "off" status of the x-ray tube which shall be located near the radiation source housing if the primary beam is controlled in this manner; or (ii) the "open" or "closed" status of the shutters which shall be located near ports on the radiation source housing, if the primary beam is controlled in this manner. (c) Warning devices shall be labeled so that their purpose is easily identified and the devices shall be conspicuous at the beam port. On equipment installed after July 1, 1989, warning devices shall have fail-safe characteristics. (d) Unused ports on radiation source housings shall be secured in the closed position in a manner which will prevent casual opening. Security requirements will be deemed met if the beam port cannot be opened without the use of tools that are not part of the closure. (e) Analytical x-ray systems shall be labeled with a readily discernable sign or signs bearing a radiation symbol which meets the requirements of R313-15-901 and the words: (i) "CAUTION-HIGH INTENSITY X-RAY BEAM," or words having a similar intent, on the x-ray tube housing; and (ii) "CAUTION RADIATION - THIS EQUIPMENT PRODUCES RADIATION WHEN ENERGIZED," or words having a similar intent, near switches that energize an x-ray tube. (f) On analytical x-ray systems with open-beam configurations which are installed after July 1, 1989, ports on the radiation source housing shall be equipped with a shutter that cannot be opened unless a collimator or a coupling has been connected to the port. (g) An easily visible warning light labeled with the words "X-RAY ON," or words having a similar intent, shall be located near switches that energize an x-ray tube and near x-ray ports. They shall be illuminated only when the tube is energized. (h) On analytical x-ray systems installed after July 1, 1989, warning lights shall have fail-safe characteristics. (i) X-ray generators shall be supplied with a protective cabinet which limits leakage radiation measured at a distance of five centimeters from its surface so that they are not capable of producing a dose equivalent in excess of 2.5 microsieverts (0.25 millirem) in one hour. (j) The components of an analytical x-ray system located in an uncontrolled area shall be arranged and include sufficient shielding or access control so that no radiation levels exist in areas surrounding the component group which could result in a dose to an individual present therein in excess of the dose limits given in R313-15-301. (2) Personnel Requirements. (a) An individual shall not be permitted to operate or maintain an analytical x-ray system unless the individual has received instruction which satisfies the requirements of R313-18-12(1). The instruction shall include: (i) identification of radiation hazards associated with the use of the analytical x-ray system; (ii) the significance of the various radiation warnings and safety devices incorporated into the analytical x-ray system, or the reasons they have not been installed on certain pieces of equipment and the extra precautions required in these cases; (iii) proper operating procedures for the analytical x-ray system; (iv) symptoms of an acute localized exposure; and (v) proper procedures for reporting an actual or suspected exposure. (b) Registrants shall maintain records which demonstrate compliance with the requirements of R313-35-100(2)(a) for a period of three years after the termination of the individual. (c) Normal operating procedures shall be written and available to analytical x-ray system workers. An individual shall not be permitted to operate analytical x-ray systems using procedures other than those specified in the normal operating procedures unless the individual has obtained written approval of the registrant or the registrant's designee. (d) An individual shall not bypass a safety device unless the individual has obtained the written approval of the registrant or the registrant's designee. Approval shall be for a specified period of time. When a safety device has been bypassed, a readily discernible sign bearing the words "SAFETY DEVICE NOT WORKING," or words having a similar intent, shall be placed on the radiation source housing. (3) Personnel Monitoring. In addition to the requirements of R313-15-502, finger or wrist dosimetric devices shall be provided to and shall be used by: (a) analytical x-ray system workers using equipment having an open-beam configuration and not equipped with a safety device; and (b) personnel maintaining analytical x-ray systems if the maintenance procedures require the presence of a primary x-ray beam when local components in the analytical x-ray system are disassembled or removed. (4) Posting. Areas or rooms containing analytical x-ray systems not considered to be cabinet x-ray systems shall be conspicuously posted to satisfy the requirements in R313-15-902. |
| R313-35-105. Portable, Hand-Held, Non-Medical X-ray Systems |
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(1) In addition to compliance to the provisions of Rule R313-35 the following sections are specific to portable, hand-held, non-medical x-ray systems, excluding portable handheld devices that are manufactured to provide inherent operator protection: (a) Protective aprons of at least 0.5 millimeter lead equivalence shall be provided for the operator to protect the operator's torso and gonads from backscatter radiation while operating the x-ray source; (b) Each operator of hand-held x-ray systems shall complete a training program supplied by the manufacturer prior to using the x-ray system. Records of training shall be maintained on file for examination by an authorized representative of the Director; and (c) For hand-held x-ray systems, the provision in Subsection R313-35-110(1)(d) of the length of electrical cord for the dead-man switch is optional. |
| R313-35-110. Veterinary X-Ray Systems |
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(1) Equipment. X-ray systems shall meet the following standards to be used for veterinary radiographic examinations. (a) The leakage radiation from the diagnostic source assembly measured at a distance of one meter shall not exceed 25.8 uC/kg (100 milliroentgens) in one hour when the x-ray tube is operated at its leakage technique factors. (b) Diaphragms, cones, or a stepless adjustable collimator shall be provided for collimating the useful beam to the area of clinical interest and shall provide the same degree of protection as is required of the diagnostic source housing. (c) A device shall be provided to terminate the exposure after a preset time or exposure. (d) A "dead-man type" exposure switch shall be provided, together with an electrical cord of sufficient length, so that the operator may stand out of the useful beam and at least six feet from the animal during x-ray exposures. (e) For stationary or mobile x-ray systems, a method shall be provided for visually defining the perimeter of the x-ray field. The total misalignment of the edges of the visually defined field with the respective edges of the x-ray field along either the length or width of the visually defined field shall not exceed six percent of the distance from the source to the center of the visually defined field when the surface upon which it appears is perpendicular to the axis of the x-ray beam. (f) For portable x-ray systems, a method shall be provided to align the center of the x-ray field with respect to the center of the image receptor to within six percent of the source to image receptor distance, and to indicate the source to image receptor distance to within six percent. (2) Structural shielding. For stationary x-ray systems, the wall, ceiling, and floor areas shall provide enough shielding to meet the requirements of R313-15-301. (3) Operating procedures. (a) Where feasible, the operator shall stand well away from the useful beam and the animal during radiographic exposures. (b) In applications in which the operator is not located beyond a protective barrier, clothing consisting of a protective apron having a lead equivalent of not less than 0.5 millimeters shall be worn by the operator and other individuals in the room during exposures. (c) An individual other than the operator shall not be in the x-ray room while exposures are being made unless the individual's assistance is required. (d) If the animal must be held by an individual, that individual shall be protected with appropriate shielding devices, for example, protective gloves and apron. The individual shall be so positioned that no unshielded part of that individual's body will be struck by the useful beam. |
| R313-35-120. X-Ray Systems Less than 1 MeV used for Non-Destructive Testing |
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(1) Cabinet x-ray systems. Cabinet x-ray systems shall meet the requirements of R313-35-80. (2) Fixed Gauges. (a) Warning Devices. A light, which is clearly visible from all accessible areas around the x-ray system, shall indicate when the x-ray system is operating. (b) Personnel Monitoring. Notwithstanding R313-15-502(1)(a), individuals conducting x-ray system maintenance requiring the x-ray beam to be on shall be provided with and required to wear personnel monitoring devices. (3) Industrial and Other X-ray Systems. (a) Equipment. (i) The registrant shall perform visual and operability checks of indication lights and warning lights before use on each day the equipment is to be used to ensure that the equipment is in good working condition. If equipment problems are found, the equipment shall be removed from service until repaired. (ii) Inspection and routine maintenance of x-ray systems, interlocks, indication lights, exposure switches, and cables shall be made at intervals not to exceed six months or before the first use thereafter to ensure the proper functioning of components important to safety. If equipment problems are found, the equipment shall be removed from service until repaired. (iii) Records demonstrating compliance with R313-35-120(3)(a)(i) shall be made when problems with the equipment are found. These records shall be maintained for a period of three years. (iv) Records demonstrating compliance with R313-35-120(3)(a)(ii) shall be made. These records shall be maintained for a period of three years. (b) Controls. X-ray systems which produce a high radiation area shall be controlled to meet the requirements of R313-15-601. (c) Personnel Monitoring Requirements. (i) Registrants shall not permit individuals to conduct x-ray operations unless all of the following conditions are met. (A) Individuals shall wear a thermoluminescent dosimeter or film badge. (I) Each film badge or thermoluminescent dosimeter shall be assigned to and worn by only one individual. (II) Film badges shall be replaced at periods not to exceed one month and thermoluminescent dosimeters shall be replaced at periods not to exceed three months. (B) Individuals shall wear a direct reading dosimeter if conducting non-destructive testing at a temporary job site or in a room or building not meeting the requirements of R313-15-301. (I) Pocket dosimeters shall have a range from zero to two millisieverts (200 millirem) and must be recharged at the beginning of each shift. (II) Direct reading dosimeters shall be read and the exposures recorded at the beginning and end of each shift. Records shall be maintained for three years after the record is made. (III) Direct reading dosimeters shall be checked at intervals not to exceed 12 months for correct response to radiation and the results shall be recorded. Records shall be maintained for a period three years from the date the record is made. Acceptable dosimeters shall read within plus or minus 20 percent of the true radiation exposure. (IV) If an individual's ion-chamber pocket dosimeter is found to be off scale or if the individual's electronic personnel dosimeter reads greater than 2 millisieverts (200 millirems), and the possibility of radiation exposure cannot be ruled out as the cause, the individual's film badge or thermoluminescent dosimeter shall be sent for processing within 24 hours. In addition, the individual shall not resume work with sources of radiation until a determination of the individual's radiation exposure has been made. (d) Controls. In addition to the requirements of R313-15-601, barriers, temporary or otherwise, and pathways leading to high radiation areas shall be identified in accordance with R313-15-902. (e) Surveillance. During non-destructive testing applications conducted at a temporary job site or in a room or building not meeting the requirements of R313-15-301, the operator shall maintain continuous direct visual surveillance of the operation to protect against unauthorized entry into a high radiation area. |
| R313-35-130. X-Ray Systems Greater than 1 MeV used for Non-Destructive Testing |
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(1) Equipment. (a) Individuals shall not receive, possess, use, transfer, own, or acquire a particle accelerator unless it is registered pursuant to R313-16-231. (b) The registrant shall perform visual and operability checks of indication lights and warning lights before use on each day the equipment is to be used to ensure that the equipment is in good working condition. If equipment problems are found, the equipment shall be removed from service until repaired. (c) Inspection and routine maintenance of x-ray systems, interlocks, indication lights, exposure switches, and cables shall be made at intervals not to exceed three months or before the first use thereafter to ensure the proper functioning of components important to safety. If equipment problems are found, the equipment shall be removed from service until repaired. (d) Records demonstrating compliance with R313-35-130(1)(b) shall be made when problems with the equipment are found. These records shall be maintained for a period of three years. (e) Records demonstrating compliance with R313-35-130(1)(c) shall be made. These records shall be maintained for a period of three years. (f) Maintenance performed on x-ray systems shall be in accordance with the manufacturer's specifications. (g) Instrumentation, readouts and controls on the particle accelerator control console shall be clearly identified and easily discernible. (h) A switch on the accelerator control console shall be routinely used to turn the accelerator beam off and on. The safety interlock system shall not be used to turn off the accelerator beam, except in an emergency. (2) Shielding and Safety Design Requirements. (a) An individual who has satisfied a criterion listed in R313-16-292, shall be consulted in the design of a particle accelerator's installation and called upon to perform a radiation survey when the accelerator is first capable of producing radiation. (b) Particle accelerator installations shall be provided with primary or secondary barriers which are sufficient to assure compliance with R313-15-201 and R313-15-301. (c) Entrances into high radiation areas or very high radiation areas shall be provided with interlocks that shut down the machine under conditions of barrier penetration. (d) When a radiation safety interlock system has been tripped, it shall only be possible to resume operation of the accelerator by manually resetting controls first at the position where the interlock has been tripped, and then at the main control console. (e) Safety interlocks shall be on separate electrical circuits which shall allow their operation independently of other safety interlocks. (f) Safety interlocks shall be fail-safe. This means that they must be designed so that defects or component failures in the interlock system prevent operation of the accelerator. (g) The registrant may apply to the Director for approval of alternate methods for controlling access to high or very high radiation areas. The Director may approve the proposed alternatives if the registrant demonstrates that the alternative methods of control will prevent unauthorized entry into a high or very high radiation area, and the alternative method does not prevent individuals from leaving a high or very high radiation area. (h) A "scram" button or other emergency power cutoff switch shall be located and easily identifiable in high radiation areas or in very high radiation areas. The cutoff switch shall include a manual reset so that the accelerator cannot be restarted from the accelerator control console without resetting the cutoff switch. (i) Safety and warning devices, including interlocks, shall be checked for proper operation at intervals not to exceed three months, and after maintenance on the safety and warning devices. Results of these tests shall be maintained for inspection at the accelerator facility for three years. (j) A copy of the current operating and emergency procedures shall be maintained at the accelerator control panel. (k) Locations designated as high radiation areas or very high radiation areas and entrances to locations designated as high radiation areas or very high radiation areas shall be equipped with easily observable flashing or rotating warning lights that operate when radiation is being produced. (l) High radiation areas or very high radiation areas shall have an audible warning device which shall be activated for 15 seconds prior to the possible creation of the high radiation area or the very high radiation area. Warning devices shall be clearly discernible in high radiation areas or in very high radiation areas. The registrant shall instruct personnel in the vicinity of the particle accelerator as to the meaning of this audible warning signal. (m) Barriers, temporary or otherwise, and pathways leading to high radiation areas or very high radiation areas shall be identified in accordance with R313-15-902. (3) Personnel Requirements. (a) Registrants shall not permit individuals to act as particle accelerator operators until the individuals have complied with the following: (i) been instructed in radiation safety; and (ii) been instructed pursuant to R313-35-50 and the applicable requirements of R313-15. (iii) Records demonstrating compliance with R313-35-130(3)(a)(i) and R313-35-130(3)(a)(ii) shall be maintained for a period of three years from the termination date of the individual. (b) Registrants shall not permit an individual to conduct x-ray operations unless the individual meets the personnel monitoring requirements of R313-35-120(3)(c). (4) Radiation Monitoring Requirements. (a) At particle accelerator facilities, there shall be available appropriate portable monitoring equipment which is operable and has been calibrated for the radiations being produced at the facility. On each day the particle accelerator is to be used, the portable monitoring equipment shall be tested for proper operation. (b) When changes have been made in shielding, operation, equipment, or occupancy of adjacent areas, a radiation protection survey shall be performed and documented by an individual who has satisfied a criterion listed in R313-16-292 or the individual designated as being responsible for radiation safety. (c) Records of radiation protection surveys, calibrations, and instrumentation tests shall be maintained at the accelerator facility for inspection by representatives of the Director for a period of three years. |
| R313-35-140. Duties and Authorities of a Radiation Safety Officer |
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Facilities operating x-ray systems under R313-35-130 shall appoint a Radiation Safety Officer. The specific duties and authorities of the Radiation Safety Officer include, but are not limited to: (1) establishing and overseeing all operating, emergency, and ALARA procedures as required by R313-15; (2) ensuring that radiation safety activities are being performed in accordance with approved procedures and regulatory requirements in the daily operation of the registrant's program; (3) overseeing and approving the training program for radiographic personnel, ensuring that appropriate and effective radiation protection practices are taught; (4) ensuring that required radiation surveys are performed and documented in accordance with the R313-35-130(4); (5) ensuring that personnel monitoring devices are calibrated and used properly by occupationally exposed personnel, that records are kept of the monitoring results, and that timely notifications are made as required by R313-15-1203; and (6) ensuring that operations are conducted safely and to assume control for instituting corrective actions including stopping of operations when necessary. |