DHS 157.86(3)(c)2.2. Supply the department with other information as the department requests. DHS 157.86(3)(c)3.3. Not operate within the state on a temporary basis in excess of 30 calendar days per year without obtaining a Wisconsin registration. DHS 157.86 HistoryHistory: CR 01-108: cr. Register July 2002 No. 559, eff. 8-1-02; CR 06-021: am. (1) (a) 1. to 5. Register October 2006 No. 610, eff. 11-1-06; correction in (1) (a) 2. made under s. 35.17, Stats., Register January 2018 No. 745. DHS 157.87DHS 157.87 Radiation safety requirements. DHS 157.87(1)(1) General requirements. Unless otherwise provided in this chapter, this subchapter applies to all radiation generating devices. Certified and certifiable cabinet x-ray systems shall also meet the requirements of 21 CFR 1020.40. DHS 157.87(1)(a)1.1. Warning devices shall be labeled so that their purpose is easily identified. DHS 157.87(1)(a)2.2. An easily visible warning device light labeled with the words “X-RAY ON,” or words having a similar meaning and intent, shall be located near any switch that energizes an x-ray tube and shall be illuminated only when the tube is energized. This warning light shall be of a fail-safe design. DHS 157.87(1)(b)1.1. All radiation generating devices equipment shall be labeled near any switch that energizes an x-ray tube with either: DHS 157.87(1)(b)1.b.b. A readily visible and discernible sign or signs bearing “CAUTION RADIATION - THIS EQUIPMENT PRODUCES RADIATION WHEN ENERGIZED,” or words having a similar meaning and intent. DHS 157.87(1)(b)2.2. For radiation generating devices with designed openings for object entries, such as baggage security screening units, the following shall be posted at or near each opening: “CAUTION – X-RAY HAZARD: DO NOT INSERT ANY PART OF THE BODY WHEN SYSTEM IS ENERGIZED”, or words having similar meaning and intent. DHS 157.87(1)(c)(c) Radiation source housing. Each x-ray tube housing shall comply with all of the following requirements: DHS 157.87(1)(c)1.1. ‘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 shall be equipped with an interlock that shuts off the high voltage to the x-ray tube if the housing is opened. DHS 157.87(1)(c)2.2. ‘Radiation emission limit.’ Each x-ray tube housing shall be so constructed that, with all shutters closed, the leakage radiation measured at a distance of 5 centimeters from the x-ray tube housing surface does not exceed 0.025 mSv (2.5 mrem) per hour. This limit shall be met at the maximum tube rating. For closed-beam systems, this requirement may be met by complying with the radiation emission limit provided in sub. (2) (d). For a radiation generating device in a shielded room, this limit may be met by measuring from any accessible surface outside the room housing the radiation generating device. For hand-held, open-beam radiation generating devices, this requirement may be met by complying with the limits in sub. (4) (c) radiation emission limit. DHS 157.87(1)(d)(d) Generator cabinet or high voltage source radiation emission limits. Each x-ray generator or high-voltage source shall be supplied with a protective cabinet which limits leakage radiation to 2.5 microSv (0.25 mrem) per hour at a distance of 5 centimeters measured at the nearest accessible surface. For closed-beam systems, this requirement may be met by complying with radiation emission limits in sub. (2) (d). For a radiation generating 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 generating device. For hand-held, open-beam radiation generating devices, this requirement may be met by complying with the radiation emission limits in sub. (4) (c). DHS 157.87(1)(e)1.1. Radiation surveys of all radiation generating devices shall be sufficient to show compliance with radiation emission requirements of this subchapter and as required by ss. DHS 157.22 and 157.25. The radiation surveys shall be sufficient to evaluate the magnitude and extent of radiation emissions and the potential radiological hazards that could be present. At a minimum, surveys shall be performed: DHS 157.87(1)(e)1.a.a. Upon installation of the equipment, and at least once every 12 months thereafter. DHS 157.87(1)(e)1.b.b. Following any change in the initial arrangement, number, or type of local components in the system. DHS 157.87(1)(e)1.c.c. Following any maintenance requiring the disassembly, removal, or repair of a local component in the system. DHS 157.87(1)(e)1.d.d. During the performance of maintenance, calibration, and other procedures if the procedures require the presence of a primary x-ray beam while any local component in the system is disassembled or removed. DHS 157.87(1)(e)1.f.f. Any time a visual inspection of the local components in the system reveals an abnormal condition. DHS 157.87(1)(e)1.g.g. Whenever a personnel monitoring device shows a significant increase over previous monitoring period or readings are approaching the limits specified in s. DHS 157.22. DHS 157.87(1)(e)2.2. The registrant shall have access to sufficiently calibrated, appropriate, and operable radiation survey instruments to make physical radiation surveys as required by this subchapter. The instruments shall be capable of detecting and measuring the types and levels of radiation involved including primary, scattered, and leakage radiation. DHS 157.87(1)(e)3.3. The registrant shall assure the maintenance and calibration of all monitoring and survey instruments used by the registrant or service provider per s. DHS 157.25. DHS 157.87(1)(e)4.4. The department may approve alternatives to the survey requirements of subd. 1., if the registrant submits to the department a request for approval of an alternative method that otherwise demonstrates compliance with this subchapter and ss. DHS 157.22 and 157.25. DHS 157.87(1)(f)(f) Posting. Each area or room containing a radiation generating device where an individual may receive 0.02 mSv (2 mrem) in any one hour or 1 mSv (100 mrem) per year shall be conspicuously posted with a sign or signs bearing the radiation symbol described in s. DHS 157.29 (1) and the words ”CAUTION - X-RAY EQUIPMENT,” “CAUTION – RADIATION GENERATING DEVICE,” or words having a similar meaning and intent. DHS 157.87(1)(g)(g) Security. Radiation generating devices shall be secured in such a way as to be only accessible to, or operable by, authorized personnel when not in operation. DHS 157.87(1)(h)1.1. ‘Procedures.’ Normal operating procedures shall be written and available to all radiation generating device workers. No individual shall be permitted to operate a radiation generating device in any manner other than that specified in the procedures unless the individual has obtained written approval of the person in control. DHS 157.87(1)(h)2.a.a. No individual shall bypass a safety device or interlock, or remove shielding unless the individual has obtained the approval of the person in control. The approval shall be for a specified period of time. DHS 157.87(1)(h)2.b.b. When a safety device or interlock has been bypassed, a readily discernible sign bearing the words ”SAFETY DEVICE NOT WORKING,” or words having a similar meaning and intent, shall be placed on the radiation source housing and at the control switch. DHS 157.87(1)(h)2.c.c. A record of any bypass of a safety device or interlock shall be maintained. The record shall contain information such as the date the alteration was made, type of alteration, length of time the unit remained in the altered condition, and post bypass survey. The record shall be signed by the person in control, the individual who made the alteration, and the individual who restored the unit to original manufacturer’s specifications. DHS 157.87(1)(h)3.a.a. The radiation generating devices hall only be activated from a control panel. DHS 157.87(1)(h)3.b.b. All indicators and controls that control the primary beam shall be identifiable and discernible through the use of labels, symbols, software displays or the equivalent. DHS 157.87(1)(h)4.a.a. An interlock shall not be used to de-activate the x-ray tube or radiation generating device, except in an emergency or during testing of the interlock system. DHS 157.87(1)(h)4.b.b. After triggering any interlock, it shall only be possible to reset the radiation generating device to full operation from a control panel. All interlocks shall be of a fail-safe design. DHS 157.87(1)(h)5.5. ‘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 shall identify which tube assembly or focal spot has been selected. The selectors shall be identified as to their function. If a letter or number is used, a reference card or table explaining the code shall be affixed to the control panel. DHS 157.87(1)(i)(i) Repair or modification of x-ray tube or radiation generating device systems. Only trained personnel or registered service providers shall be permitted to install, repair, or make modifications to the radiation generating device. No operation involving removal of covers, shielding materials or tube housings or modifications to shutters, collimators, or beam stops shall be performed without ensuring that the tube is off and will remain off until safe conditions have been restored. The main power switch with a lockout tagout, rather than interlocks, shall be used for routine shutdown in preparation for repairs. It is the responsibility of the registrant to assure that qualified personnel install, repair, or make modifications to the radiation generating device. DHS 157.87(1)(j)1.1. Tests of all safety devices, such as interlocks, shutters, warning lights, and required emergency shut-off switches shall be conducted at intervals not to exceed 6 months on all operable radiation generating devices. DHS 157.87(1)(j)2.2. If any safety device fails during testing, the radiation generating device shall be removed from service until the safety device failure is corrected or proper temporary administrative controls are established and approved in writing by the person in control. DHS 157.87(1)(j)3.3. Records of safety device tests, check dates, findings and corrective actions shall be available for inspection and maintained for 5 years. DHS 157.87(1)(j)4.4. Records shall include the date of each test, a list of the safety devices tested, survey instrument information, calibration date, the results of each test, the name of the person performing each test and corrective actions taken for safety devices that fail each required test. DHS 157.87(1)(j)5.5. Testing of safety devices may be deferred if the unit or installation is clearly marked and kept out of service. Units or installations brought back into service after exceeding a 6 month interval shall be tested prior to use. DHS 157.87(1)(j)6.6. If testing of a safety device cannot be performed due to manufacturer design, the registrant shall document that the safety device will not be tested and why the safety device cannot be tested. DHS 157.87(1)(k)(k) Instruction and training. The registrant shall document the scope of training required for the radiation generating device they possess in accordance with this section. No individual shall be permitted to operate or maintain a radiation generating device, or enter a shielded room without appropriate instruction and training. Records shall be maintained onsite of all required training and instruction, and made available for review by the department. Each individual permitted to operate or maintain a radiation generating device shall receive instruction, hands-on training with the radiation generating device and equipment, and demonstrate competence in all of the following: DHS 157.87(1)(k)1.1. Types of radiation and identification of radiation hazards associated with the use of the radiation generating device and associated equipment and precautions or measures to take to minimize radiation exposure. DHS 157.87(1)(k)2.2. Significance of the various radiation warning, safety devices, and interlocks incorporated into the equipment, or the reasons they have not been installed on certain pieces of equipment and the extra precautions required in those cases. DHS 157.87(1)(k)3.3. Commensurate with potential hazards of use, biological effects of radiation, radiation risks, and recognition of symptoms of an acute localized exposure. DHS 157.87(1)(k)4.4. Normal operating procedures and procedures to prevent unauthorized use for each type of radiation generating device and associated equipment. DHS 157.87(1)(k)5.5. Procedures for reporting an actual or suspected accidental exposure or other radiation safety concerns, such as any unusual occurrence or malfunction that may involve exposure to radiation. DHS 157.87(1)(L)1.1. The registrant’s management shall make the final decision to use any radiation generating device and bear responsibility for radiation safety. DHS 157.87(1)(L)2.2. The registrant’s management shall designate an individual responsible for radiation safety. This individual shall have direct access to management for radiation safety issues. This individual shall have training and experience commensurate with the scope of the radiation safety program to carry out all of the following responsibilities: DHS 157.87(1)(L)2.a.a. Ensuring that all radiation generating devices are operated within the limitations of the established radiation safety program and operating procedures. DHS 157.87(1)(L)2.b.b. Instructing personnel with regard to safe working practices and ensuring all personnel are trained in radiation safety commensurate with the hazards of the job. DHS 157.87(1)(L)2.c.c. Investigating any incident of abnormal operation or exposure or suspected overexposure of personnel to determine the cause, take remedial action, and report the incident to the proper authorities. DHS 157.87(1)(L)2.d.d. Ensuring that safety devices, interlocks, warning signals, labels, postings, and signs are functioning and located where required. DHS 157.87(2)(2) Additional requirements for closed-beam radiation generating devices. In addition to the requirements of sub. (1), all of the following apply to all closed-beam x-ray radiation generating devices: DHS 157.87(2)(a)(a) System enclosure. The radiation source, sample or object, detector, and, if used, analyzing crystal shall be enclosed in a chamber or coupled chambers that cannot be entered by any part of the body during normal operation. DHS 157.87(2)(b)(b) Interlocks. All doors and panels accessing the radiation generating device shall be interlocked. The interlocks shall be of a fail-safe design. DHS 157.87(2)(c)(c) Interlock functions. The system enclosure and sample chamber closure shall be interlocked with the x–ray tube high voltage supply or a shutter in the primary beam so that no x-ray beam can enter the sample or object chamber while it is open unless the interlock has been conspicuously and deliberately defeated. The interlock shall be of fail-safe design or adequate administrative controls shall be exercised to ensure operations will not continue without a proper functioning interlock. DHS 157.87(2)(d)(d) Radiation emission limit. The radiation emission for all closed beam radiation generating devices shall not exceed a dose rate of 0.005 mSv (0.5 mrem) in one hour at five centimeters outside any accessible surface. DHS 157.87(2)(e)(e) Security screening units. Security screening units shall be provided with means to ensure operator presence at the control area in a position which permits surveillance of the openings and doors during generation of x-ray radiation. The means provided shall meet any of the following conditions: DHS 157.87(2)(e)1.1. During an exposure or preset succession of exposures of one-half second or greater duration, the operator is able to terminate the exposure or preset succession of exposures at any time. DHS 157.87(2)(e)2.2. During an exposure or preset succession of exposures of less than one-half second duration, the operator is able to prevent additional exposures after the completion of the exposure in progress. DHS 157.87(3)(3) Additional requirements for open-beam radiation generating devices. The registrant shall submit a written explanation of the need to utilize the open beam configuration instead of closed-beam systems and receive the written approval of the department prior to use. In addition to the requirements in sub. (1) all of the following apply to all open-beam radiation generating devices not otherwise addressed in this subchapter: DHS 157.87(3)(a)1.1. The registrant shall use a safety device which prevents the entry of any portion of the operator’s body into the path of the primary beam or which causes the primary beam to be shut off upon entry into its path, unless otherwise authorized by the department or this subchapter. DHS 157.87(3)(a)2.2. If the registrant’s use of the open-beam radiation generating device does not permit the use of a safety device described in subd. 1. or 4., the registrant shall submit a written justification for why such a safety device cannot be used and receive the written approval of the department prior to use. The documented request and approval, include information about the absence of safety devices, shall be available for inspection as long the open-beam radiation generating device is in use. A record of this documentation shall be retained for 5 years after the open-beam radiation generating device is used. DHS 157.87(3)(a)3.3. If the registrant does not use a safety device described in subd. 1., the registrant shall employ alternative methods such as policies and procedures to minimize the possibility of unnecessary exposure. These alternative methods shall be documented and available for inspection as long as these methods are employed. A record of this documentation shall be retained for 5 years after the method is no longer employed. DHS 157.87(3)(a)4.4. For portable open-beam radiation generating devices that are manufactured to be used hand-held, or potentially used as a hand-held, without a safety device described in subd. 1, this safety device requirement shall be met by complying with all the requirements in sub. (4) prior to use. DHS 157.87(3)(b)(b) X-ray on status. For open-beam equipment, radiation generating devices shall be provided with a readily discernible and active indication of all of the following: DHS 157.87(3)(b)1.1. ‘X-ray tube “on-off” status.’ An on-off status indicator shall be of a fail-safe design and be located near the radiation source housing. The warning lights as required by sub. (1) (a) 2. may meet this requirement if the warning lights are readily discernible and viewable by anyone near the primary beam. DHS 157.87(3)(b)2.2. ‘Shutter “open-closed” status.’ An open-closed status indicator shall be of a fail-safe design and be located at the control panel. If the primary beam is controlled with a shutter, it shall be near each beam port on the radiation source housing. The shutter status indicator shall be clearly labeled as to the meaning of the status of the device. The status indicator at the control panel may meet the requirement for the status indicator at the beam port if the status indicator at the control panel is readily discernible and viewable by anyone near the primary beam. DHS 157.87(3)(c)(c) Labeling. Each unit shall be labeled at or near the x-ray exit beam port to identify the location of the beam with the words, “CAUTION - X-RAY BEAM”, “CAUTION – HIGH INTENSITY X-RAY BEAM”, or words having a similar meaning and intent. DHS 157.87(3)(d)(d) Beam ports. Unused beam ports on radiation source housings shall be secured in the closed position in a manner which will prevent inadvertent opening. DHS 157.87(3)(e)(e) Shutters. On open-beam radiation generating device configurations that are designed to accommodate interchangeable components, such as apertures, filters, or target materials, each beam port on the radiation source housing shall be equipped with a shutter that cannot be opened unless a collimator or a component coupling has been connected to the beam port.
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Department of Health Services (DHS)
Chs. DHS 110-199; Health
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