Subchapter B. GENERAL TECHNICAL REQUIREMENTS
Sec.
227a.10. Radiation safety program.
227a.11. Warning devices.
227a.12. Labeling.
227a.13. Radiation source housing.
227a.14. Generating cabinet or high voltage source radiation emission limits.
227a.15. Surveys.
227a.16. Posting.
227a.17. Security.
227a.18. Operating requirements.
227a.19. Repair or modification of X-ray tube or radiation-producing device.
227a.20. Testing of safety devices.
227a.21. Instruction and training.
227a.22. Radiation protection responsibility.
Cross References This subchapter cited in 25 Pa. Code § 227a.50 (relating to handheld radiation-producing devices); 25 Pa. Code § 227a.51 (relating to bomb detection radiation-producing devices); and 25 Pa. Code § 227a.52 (relating to radiation-producing devices used in individual security screening).
§ 227a.10. Radiation safety program.
A registrant who intends to use radiation-producing devices shall have a program for training personnel, written normal operating procedures and emergency procedures, individual monitoring reports required under 10 CFR 20.2206(a)(2) (relating to reports of individual monitoring), an internal review system and an organizational structure for radiation protection which includes specified delegations of authority and responsibility for operation of the program.
§ 227a.11. Warning devices.
(a) Label. Warning devices must be labeled so that their purpose is easily identified.
(b) Warning device light. An easily visible warning device light labeled with the words ‘‘X-RAY ON,’’ or words having a similar intent, must be located near every switch that energizes an X-ray tube and must be illuminated only when the tube is energized. This warning light must be of a fail-safe design.
Cross References This section cited in 25 Pa. Code § 227a.41 (relating to X-ray on status).
§ 227a.12. Labeling.
(a) General rule. A radiation-producing device must be labeled with a readily visible and discernible sign or signs bearing the radiation symbol and the words: ‘‘CAUTION RADIATION—THIS EQUIPMENT PRODUCES RADIATION WHEN ENERGIZED,’’ or words having a similar intent, near every switch that energizes an X-ray tube.
(b) Devices with designed openings. For radiation-producing devices with designed openings for object entries, such as baggage units, the following must be posted at or near every opening: ‘‘CAUTION—X-RAY HAZARD: DO NOT INSERT ANY PART OF THE BODY WHEN SYSTEM IS ENERGIZED’’ or words having similar intent.
Cross References This section cited in 25 Pa. Code § 227a.3 (relating to exemptions).
§ 227a.13. Radiation source housing.
(a) Interlock. When the X-ray tube housing is the primary shielding for the X-ray tube and is intended to be opened for normal use or maintenance, the housing must be equipped with an interlock that shuts off the high voltage to the X-ray tube if the housing is opened.
(b) Radiation emission limit. Except as specified elsewhere in this chapter, each X-ray tube housing must be constructed so that, with all shutters closed, the leakage radiation measured at 5 centimeters from the X-ray tube housing surface does not exceed 2.5 mrem (0.025 mSv) per hour. This limit must be met at the maximum tube rating.
Cross References This section cited in 25 Pa. Code § 227a.50 (relating to handheld radiation-producing devices).
§ 227a.14. Generating cabinet or high voltage source radiation emission limits.
Each X-ray generator or high-voltage source must be supplied with a protective cabinet which limits leakage radiation to 0.5 mrem (5.0 µSv) per hour at 5 centimeters measured at the nearest accessible surface. For closed-beam radiation-producing devices, this requirement may be met by complying with § 227a.33 (relating to radiation emission limit). For a radiation-producing device in a shielded room with the high-voltage generator also inside the shielded room, this limit may be met by measuring from any accessible surface outside the room housing the radiation-producing device. For hand-held, open-beam radiation-producing devices, this requirement may be met by complying with the limits under § 227a.50(3) (relating to handheld radiation-producing devices).
Cross References This section cited in 25 Pa. Code § 227a.50 (relating to handheld radiation-producing devices).
§ 227a.15. Surveys.
(a) General rule. Radiation surveys of all radiation-producing devices must be sufficient to show compliance under § 219.51 (relating to radiation dose limits for individual members of the public) and to show compliance with radiation emission requirements of this chapter. The radiation surveys must be sufficient to evaluate the magnitude and extent of radiation emissions and the potential radiological hazards that could be present. Records of these surveys must be maintained for 5 years for inspection by the Department. At a minimum, surveys shall be performed in the following instances:
(1) Upon installation of the equipment and at least once every 12 months thereafter.
(2) Following a change in the initial arrangement, number or type of local components in the system, and prior to returning to service.
(3) Following maintenance requiring the disassembly, removal or repair of a local component in the system, and prior to returning to service.
(4) During the performance of maintenance, calibration and another procedure if the procedure requires the presence of a primary beam while any local component in the system is disassembled or removed.
(5) Following bypass of a safety device or interlock as required by § 227a.18(b) (relating to operating requirements).
(6) When a visual inspection of the local components in the system reveals an abnormal condition.
(7) If a personnel monitoring device shows a radiation exposure that is greater than 25% of the annual occupational dose limit as specified in 10 CFR 20.1201 (relating to occupational dose limits for adults).
(b) Instrument requirements. The registrant shall have access to sufficiently calibrated, appropriate and operable radiation survey instruments to make physical radiation surveys as required by this chapter. The instruments must be capable of detecting and measuring the types and levels of radiation involved, including primary, scattered and leakage radiation.
(c) Maintenance and calibration. The registrant shall ensure the maintenance and calibration of all monitoring and survey instruments under 10 CFR 20.1501 (relating to general).
(d) Exception. Radiation surveys are not required if a registrant otherwise demonstrates compliance under this chapter to the satisfaction of the Department.
Cross References This section cited in 25 Pa. Code § 227a.18 (relating to operating requirements).
§ 227a.16. Posting.
Each area or room containing a radiation-producing device where an individual may receive 2 mrem (0.02 mSv) in any 1 hour or 100 mrem (1 mSv) per year shall be conspicuously posted with a sign or signs bearing the radiation symbol and ‘‘CAUTION RADIATION—THIS EQUIPMENT PRODUCES RADIATION WHEN ENERGIZED,’’ or words having a similar intent.
Cross References This section cited in 25 Pa. Code § 227a.3 (relating to exemptions); and 25 Pa. Code § 227a.51 (relating to bomb detection radiation-producing devices).
§ 227a.17. Security.
A radiation-producing device must be secured to be accessible only to authorized personnel at all times.
Cross References This section cited in 25 Pa. Code § 227a.51 (relating to bomb detection radiation-producing devices).
§ 227a.18. Operating requirements.
(a) Procedures. Normal operating procedures shall be written and available to all radiation-producing device workers. An individual may not operate a radiation-producing device in a manner other than that specified in the normal operating procedures unless the individual has obtained written approval of the RSO.
(b) Bypassing.
(1) An individual may not bypass a safety device or interlock, and may not remove shielding, unless the individual has obtained approval of the RSO. The approval shall be limited to a specified period of time.
(2) When a safety device or interlock has been bypassed, a conspicuous sign bearing the words ‘‘SAFETY DEVICE NOT WORKING,’’ or words having a similar intent, shall be placed on the radiation source housing and at the control switch.
(3) A record of a bypass of a safety device or interlock shall be maintained for 5 years. The record must contain all of the following information:
(i) The date the bypass was made.
(ii) A detailed description of the bypass.
(iii) The length of time the unit remained in the altered condition.
(iv) The post bypass survey as noted in § 227a.15 (relating to surveys).
(v) Other relevant information for the bypass.
(4) A record of a bypass shall be signed by the RSO, the individual who performed the bypass and the individual who restored the unit to its original condition.
(c) Control panel.
(1) The radiation-producing device may only be activated from a control panel.
(2) Indicators and controls that control the primary beam must be identifiable and discernible through the use of labels, symbols, software displays or equivalent methods.
(d) Interlocks.
(1) An interlock may not be used to de-activate the X-ray tube of a radiation-producing device, except in an emergency or during testing of the interlock system.
(2) After an interlock is triggered, resetting the radiation-producing device to full operation must only be possible from a control panel.
(3) Interlocks must be of a fail-safe design.
(e) Multiple sources. If more than one X-ray tube assembly or focal spot can be operated sequentially or simultaneously from a control panel, visual indicators must identify which tube assembly or focal spot has been selected. The selectors must be identified as to their function. If a letter or number is used, a reference card or table explaining the code must be affixed to the control panel.
Cross References This section cited in 25 Pa. Code § 227a.15 (relating to surveys).
§ 227a.19. Repair or modification of X-ray tube or radiation-producing device.
Only trained personnel or a registered service provider may install, repair or make modifications to a radiation-producing device. An operation involving removal of covers, shielding materials or tube housings, or an operation involving modifications to shutters, collimators or beam stops, may only be performed after ascertaining that the tube is off and will remain off until safe conditions have been restored. The main power switch with a lock-out/tag-out, rather than interlocks, shall be used for routine shutdown in preparation for repairs. The registrant shall ensure that only qualified personnel install, repair and make modifications to a radiation-producing device.
§ 227a.20. Testing of safety devices.
(a) Testing interval. Testing of safety devices, such as interlocks, shutters, warning lights and required emergency shut-off switches, shall be conducted on all operable radiation-producing devices at intervals not to exceed 12 months.
(b) Device failure. If a safety device fails during testing, the radiation-producing device shall be removed from service until the safety device is corrected or proper temporary administrative controls are established. The RSO shall approve in writing the temporary administrative controls.
(c) Availability of records. Records of safety device tests, check dates, findings and corrective actions shall be available for inspection and maintained for 5 years.
(d) Record requirements. Records required under this section must include the date of the test, a list of the safety devices tested, survey instrument information, the calibration date, the results of the test, the name of the person performing the test and, for safety devices that fail the required test, corrective actions taken.
(e) Out of service requirements. Testing of safety devices may be deferred if the unit or installation, or both, are clearly marked and kept out of service. A unit or installation, or both, brought back into service after the 12-month interval specified in subsection (a) shall be tested prior to use.
(f) Testing constraints. If testing of a safety device cannot be performed due to manufacturer design, the registrant shall document that the safety device cannot be tested and specify why the safety device cannot be tested.
§ 227a.21. Instruction and training.
The registrant shall document the scope of training required for the radiation-producing device the registrant possesses under this section. An individual may not operate or maintain a radiation-producing device or enter a shielded room without appropriate instruction and training. Records of all required training and instruction shall be maintained onsite and made available for review by the Department for 5 years. Before an individual may operate or maintain a radiation-producing device or enter a shielded room, the individual shall receive instruction in and shall demonstrate competence through a performance evaluation by the registrant, as to the following:
(1) Types of radiation, identification of radiation hazards associated with the use of the radiation-producing device and associated equipment, and precautions or measures to take to minimize radiation exposure.
(2) Significance of the various radiation warnings, safety devices and interlocks incorporated into the equipment, or the reasons that warnings, safety devices or interlocks have not been installed on equipment and the extra precautions required in these cases.
(3) Commensurate with potential hazards of use, biological effects of radiation, radiation risks and recognition of symptoms of an acute localized exposure.
(4) Normal operating procedures for each type of radiation-producing device and associated equipment, as well as procedures to prevent unauthorized use. Training in normal operating procedures must include hands-on training.
(5) Emergency procedures for reporting actual or suspected accidental exposure and other radiation safety concerns, such as an unusual occurrence or malfunction that may involve exposure to radiation.
(6) Radiation survey performance, where applicable.
Cross References This section cited in 25 Pa. Code § 227a.3 (relating to exemptions); 25 Pa. Code § 227a.49 (relating to instruction and training); and 25 Pa. Code § 227a.50 (relating to handheld radiation-producing devices).
§ 227a.22. Radiation protection responsibility.
(a) Responsibility. The registrant’s designated senior management shall make the decision to use a radiation-producing device. The registrant shall document the designated senior management responsible for radiation safety and those records shall be available for inspection by the Department and maintained for 5 years.
(b) RSO designation. The registrant’s senior management shall designate an RSO. This individual shall have direct access to senior management for radiation safety issues. This individual shall have training and experience commensurate with the scope of the radiation safety program to carry out the following responsibilities:
(1) Ensuring that all radiation-producing devices are operated within the limitations of the established radiation safety program and normal operating procedures.
(2) Instructing personnel on safe working practices and ensuring that all personnel are trained in radiation safety commensurate with the hazards of the job.
(3) Investigating all incidents of abnormal operation and of abnormal exposure or suspected overexposure of an individual to determine the cause of the incident, to take remedial action and to report the incident to the proper authority.
(4) Ensuring that safety devices, interlocks, warning signals, labels, postings and signs are functioning and located where required.
(5) Retaining all records required to show compliance with this section, including annual reviews of the radiation protection program content and implementation and the documentation of its findings, as required in § 219.5 (relating to incorporation by reference), and incorporating by reference 10 CFR 20.1101(c) (relating to radiation protection programs), and making the records available for review by the Department for 5 years.
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