Section DHS 157.87 - Radiation safety requirements(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.(a)Warning devices.1. Warning devices shall be labeled so that their purpose is easily identified.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.(b)Labeling.1. All radiation generating devices equipment shall be labeled near any switch that energizes an x-ray tube with either: a. A readily visible and discernible sign or signs bearing the radiation symbolb. 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.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.(c)Radiation source housing. Each x-ray tube housing shall comply with all of the following requirements: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.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.(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).(e)Surveys.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: a. Upon installation of the equipment, and at least once every 12 months thereafter.b. Following any change in the initial arrangement, number, or type of local components in the system.c. Following any maintenance requiring the disassembly, removal, or repair of a local component in the system.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.e. After bypassing a safety device or interlock as required in par. (h).f. Any time a visual inspection of the local components in the system reveals an abnormal condition.g. Whenever a personnel monitoring device shows a significant increase over previous monitoring period or readings are approaching the limits specified in s. DHS 157.22.2. 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.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 157.25.4. 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.(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.(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.(h)Operating requirements.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.2. 'Bypassing.' 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.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.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.3. 'Control panel.' a. The radiation generating devices hall only be activated from a control panel.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.4. 'Interlocks.' 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.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.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.(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.(j)Testing of safety devices.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.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.3. Records of safety device tests, check dates, findings and corrective actions shall be available for inspection and maintained for 5 years.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.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.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.(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: 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.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.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 and procedures to prevent unauthorized use for each type of radiation generating device and associated equipment.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.6. Performing surveys where applicable.(l)Radiation protection responsibility.1. The registrant's management shall make the final decision to use any radiation generating device and bear responsibility for radiation safety.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: a. Ensuring that all radiation generating devices are operated within the limitations of the established radiation safety program and operating procedures.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.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.d. Ensuring that safety devices, interlocks, warning signals, labels, postings, and signs are functioning and located where required.e. Maintaining all radiation safety records.(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: (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.(b)Interlocks. All doors and panels accessing the radiation generating device shall be interlocked. The interlocks shall be of a fail-safe design.(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.(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.(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: 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.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.(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: (a)Safety device.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.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.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.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.(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: 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.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.(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.(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.(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.(f)Radiation emission limits. The local components of an open-beam radiation generating device, such as portable shielding, room walls, and designed housing, shall be located and arranged and shall include sufficient shielding or access control such that no radiation emissions exist, exclusive of the primary beam, in any area surrounding the local component group which could result in a dose to an individual present therein in excess of the dose limits as outlined in s. DHS 157.25. These emissions shall be met at any specified tube rating.(g)Primary beam attenuation. In cases where the primary x-ray beam is not intercepted by the detector device under all conditions of operation, protective measures shall be provided, such as auxiliary shielding or administrative procedures, to avoid exposure to any individual from the transmitted primary x-ray beam.(h)Operator attendance. The operator shall be in immediate attendance at all times when the equipment is in operation except when the area is locked, or the equipment is secured to protect against unauthorized or accidental entry.(i)Control of access. If the radiation generating device is not in a restricted area, the operator shall be able to control access to the radiation generating device at all times during operation. If the radiation generating device is not in a restricted area and the radiation generating device is capable of creating a radiation area or, the operator shall be able to control access to the radiation generating device at all times during operation, and do all the following: 1. Conspicuously identify radiation areas. The radiation source shall be within a conspicuous perimeter that identifies the area in which the dose equivalent rate exceeds 0.05 mSv (5 mrem) per hour. The area identified shall be suitably posted with "CAUTION -RADIATION AREA" signs at the perimeter. The operator shall ensure that no one is inside or enters the radiation area during operation of the radiation generating device.2. Conspicuously identify high radiation areas. The radiation source shall be within a conspicuous perimeter that identifies the area in which the dose equivalent rate exceeds 1 mSv (100 mrem) per hour. The area identified shall be suitably posted with "CAUTION - HIGH RADIATION AREA" signs at the perimeter. The operator shall ensure that no one is inside or enters the high radiation area during operation of the radiation generating device.3. Perform a visual check of the controlled area to ensure it is free of all unauthorized personnel immediately prior to activating or exposing the radiation source.4. Maintain surveillance of the exposure area during operation, either visually or by other reliable means to ensure that no person enters the area.5. With the exception of hand-held x-ray systems, when approaching the radiation source, following the conclusion of an exposure, use a suitable calibrated and operable radiation detection instrument to verify that the radiation source is in its fully shielded condition or that the x-ray tube has been de-energized.6. Wear a personal alarming dose rate meter to approach the work area. The radiation field in the work area must be uniform such that the personal alarming dose rate meter responds to radiation exposure to any part of the body. The personal alarming dose rate meter shall not be used to measure radiation levels required under subds. 7. to 9., nor shall it be used to indicate the presence of a radiation source for potential non-uniform exposure, such as may occur during machine maintenance or work in a radiation generating device target area. The personal alarming dose rate meter shall meet all of the following: a. Is appropriately designed and calibrated for the type of x-ray emitted, such as pulse or continuous.b. Is set at an appropriate level to detect the presence of the radiation source, for example 0.02 mSv (2 mrem) per hour.c. Has been source-checked for response prior to use.7. Perform measurement of radiation levels for a radiation survey using an appropriate calibrated radiation survey meter required by subs. (1) (e) 1. and 2. A radiation survey meter shall also be used when there is potential for non-uniform exposure to personnel, such as may occur during machine maintenance or work in a radiation generating device target area.8. During the first exposure for each set up of the device, measure the radiation levels around the perimeter of the controlled area. The perimeter shall be adjusted accordingly to meet the access control requirement for radiation areas or high radiation areas before subsequent exposures are made.9. Conduct the survey around the perimeter for each new operating condition and adjust the perimeter accordingly. The area of operation shall be monitored periodically if radiation levels are variable.(j)Instruction and training. In addition to the requirements in sub. (1) (k), each individual permitted to operate or maintain an open-beam radiation generating device shall receive more specific and detailed instruction in and demonstrate competence in all of the following topics: 1. Sources and magnitude of common radiation exposure.2. Units of radiation measurement.3. Radiation protection concepts of time, distance, shielding, and ALARA.4. Procedures and rights relating to a declared pregnancy.5. Regulatory requirements and area postings.6. Worker, embryo or fetus, and public dose limits.7. Proper use of survey instruments and dosimetry.8. The policies and procedures required by this subsection.(k)Personnel monitoring. In addition to the requirements of s. DHS 157.25, extremity dosimetry shall be provided and used by all of the following: 1. Personnel working with or routinely working near and having potential for exposure to, the primary beam of an open-beam radiation generating device.2. Personnel maintaining radiation generating devices if the maintenance procedures require the presence of a primary radiation beam when any local component in the radiation generating device is disassembled or removed.(4) ADDITIONAL REQUIREMENTS FOR OPEN-BEAM, HAND-HELD RADIATION GENERATING DEVICES. In addition to the requirements in subs. (1) and (3) the following applies to open-beam, hand-held radiation generating devices: (a)Procedures. All registrants possessing open-beam, hand-held radiation generating device shall make their operating policies and procedures available for review by the department. Operating policies and procedures shall contain measures to ensure that all of the following occur: 1. Radiation protection is provided to meet public dose limits in s. DHS 157.23.2. Radiation protection is provided equivalent to that afforded in sub. (3) (g).3. The operator will not hold the sample during operation of the radiation generating device and the operator's hands will not approach the primary beam.4. The operator will not aim the primary beam at themselves or at any individual during operation of the radiation generating device.5. Operator radiation exposure is as low as reasonably achievable, for example, by use of ancillary equipment that will reduce exposure.(b)Training. In addition to the training requirements of subs. (1) (k) and (3) (j), the registrant shall provide training for all users and operators on the subjects in par. (a). Records shall be maintained of all user and operator training.(c)Radiation emission limit. For hand-held radiation generating devices, the limits in subs. (1) (c) 2. and (d), excluding the primary beam, shall be met if the radiation emission at any accessible surface of the radiation generating device does not exceed 0.025 mSv (2.5 mrem) per hour at 5 cm.(d)Extremity monitoring. For the purposes of the requirements sub. (3) (k) 1., operators of hand-held radiation generating devices shall be considered as working near the primary beam.(5) SHIELDED ROOM RADIATION GENERATING DEVICES. For radiation generating devices that do not meet the dose limits of s. DHS 157.25, the radiation generating device may be maintained inside a shielded room such that the exterior of the room meets the dose limits of s. DHS 157.25 when the radiation generating device is activated. Radiation generating devices in a shielded room shall meet the requirements in sub. (1) and the following: (a)Posting. The door to the room containing the radiation generating device shall be posted "CAUTION - RADIATION AREA", or "CAUTION - HIGH RADIATION AREA", or "GRAVE DANGER - VERY HIGH RADIATION AREA", as required by s. DHS 157.29 (2).(b)Entrance interlocks. All entrances into the shielded room shall be provided with interlocks. After an interlock has been interrupted, broken, or tripped, it shall be possible to cause x-rays to be produced again only from the control panel. Interlocks shall not be used to shut off the x-ray equipment except in an emergency or during testing.(c)Entrance warning devices. All entrances into the shielded room shall be equipped with a conspicuously visible warning device, which need not be flashing or rotating but which operates only when radiation is being produced. The warning device shall be labeled in accordance with sub. (1) a).(d)Room warning lights. The interior of the shielded room shall be provided with flashing or rotating warning lights that operate when, and only when, radiation is being produced. These lights shall be positioned so that they can be observed from any position or orientation within the room. The lights shall be posted indicating the meaning of the warning signal and instructions of actions to take when the light is lit. The posting shall be legible, conspicuous, and accessible to view.(e)Audible room warning device. An audible warning signal within the room shall be actuated for at least 10 seconds immediately prior to the first initiation of radiation after the closing of any opening that can admit personnel. The registrant shall post the meaning of the warning signal and instructions of action to take when the alarm sounds. The posting shall be legible, conspicuous, and accessible to view.(f)Emergency shut-off. If dose rates exceed the high radiation area limits in s. DHS 157.26, emergency shut-off switches shall be located within the high radiation areas so as to be accessible to individuals therein within 10 seconds. These switches and their mode of operation shall be identified by a conspicuously posted sign adjacent to the switch. The emergency shut-off switches shall include a manual reset that must be reset at the switch before x-rays are produced from the control panel. After an emergency shut-off switch has been activated, it shall only be possible to produce x-rays again from the control panel.(g)Separate electrical systems. The interlock system and the emergency shut-off system shall be separate electrical and mechanical systems.(h)Egress from shielded room. A person within the room housing a radiation generating device shall be able to egress at all times.(i)Entry into the shielded room.1. After each exposure and before entry of any personnel, a survey shall be performed upon entry to the shielded room to determine that the radiation generating device is no longer producing radiation.2. Personnel devices providing an audible signal when activated by radiation shall be acceptable for the survey requirement of subd. 1. if all of the following conditions are met:a. Personnel devices are to be checked daily for proper operation and a record of this check is maintained.b. The personnel device is designed to clearly indicate entry into a 0.02 mSv (2 mrem) per hour or greater radiation field.c. All personnel working with the radiation generating device are provided with a personnel device.3. Stationary area monitors providing an audible signal when activated by radiation shall be acceptable for the survey requirement of subd. 1. if all of the following conditions are met:a. Stationary detection devices are checked daily for proper operation and a record of this check is maintained.b. The stationary device is designed to clearly indicate entry into a 0.02 mSv (2 mrem) per hour or greater radiation field.c. Stationary area monitors are calibrated annually to determine that the audible signal operates at a 0.02 mSv (2 mrem) per hour radiation field.(j)Personnel monitoring. All personnel associated with the x-ray equipment are provided with personnel monitoring devices that are calibrated for the x-ray energies being utilized. Records of personnel exposure are maintained.(k)Training. No registrant shall permit any individual to operate a radiation generating device in a shielded room until the individual has received a copy of, instruction in, and demonstrated an understanding of, operating and emergency procedures for the unit and competence in its use. Records are maintained of all operator training.(l)Control panel security. The equipment control panel is provided with a locking device to prevent unauthorized use. The locking device shall, when locked, prevent the production of radiation by the equipment.(m)Malfunctions. If a safety or warning device malfunctions, the control panel shall be locked in the "off" position. The control panel shall not be used, except as may be necessary for repair or replacement of the malfunctioning safety or warning device, until the safety or warning device is functioning properly.(6) BOMB DETECTION RADIOGRAPHIC EQUIPMENT. In addition to the requirements of sub. (1), all of the following requirements apply to bomb detection radiographic equipment: (a)Control panel security. When not in use, each bomb detection radiographic machine shall be locked to prevent unauthorized use. This is in addition to the requirements of sub. (1) (g).(b)Utilization log. The registrant shall maintain for each bomb detection radiographic machine a utilization log. This log shall record the description of the unit, the date removed from storage, the date returned to storage, the identity and signature of the person to whom the device is assigned, the dates of use and the site of use.(c)Area control. The registrant shall provide security to prevent entry by individuals from any point when the machine is energized during training.(7) RADIATION GENERATING DEVICES USED IN PERSONNEL SECURITY SCREENING OR VEHICLE SCREENING FOR PUBLIC PROTECTION. In addition to sub. (1), a registrant requesting department approval for a radiation generating device to be used in personnel security screening or vehicle screening with intended exposure of human occupants to the primary beam for public protection shall submit in writing all of the following information to the department for evaluation and approval, and show how the dose limits in this subsection will be met: (a)Efficacy evaluation. An evaluation of all known alternate methods that could achieve the goals of the security screening program, and why these methods will not be used.(b)Equipment evaluation. Radiation generating devices used for personnel security screening of humans shall be evaluated every 12 months by a qualified individual, such as the manufacture's trained service engineer, for optimization of image quality and radiation dose.(c)Dose limits for general-use systems. For screening systems where the system is used without regard to the number of individuals scanned or number of scans per individual in a year, an effective dose for a single complete screening shall be limited to 0.25 microSv (25 microrem).(d)Dose limits for limited-use systems. For screening systems where equipment is capable of operation greater than 0.25 microSv (25 microrem) per screening, the effective dose per screening shall be less than or equal to 0.01 mSv (1 mrem). These systems shall only be use under the following conditions: 1. Used only when the additional radiation is required to create the image.2. Not used routinely on individuals.(e)Dose limits for repeat security screenings. Individuals subject to repeat security screening at a single facility shall not receive an effective dose greater than 0.25 mSv (25 mrem) in any one year at the registrant's facility.(f)Vehicle limitations.1. When the procedures for operation of a mobile or fixed radiation generating device used for security screening of vehicles includes knowingly exposing human occupants to the primary beam when screening vehicles, structures or containers, the system shall be subject to the same requirements as general-use or limited-use systems as provided in pars. (a) to (e).2. If the requirements in pars. (a) to (e) cannot be met, and if vehicle occupants are knowingly exposed to the primary beam of a security screening system, then there shall be means to assure the occupied portion of the vehicle is outside of the scan area while the primary beam is emitted, or procedures shall be established and implemented to assure that no occupants are present in the vehicle during screening.3. The effective dose to an individual for a single inadvertent exposure to the primary beam shall not exceed one mSv (100 mrem). The reliability of the procedure used to assure that there are no occupants of a vehicle to be scanned shall be commensurate with the potential severity of an inadvertent exposure. If the one mSv (100 mrem) limit cannot be assured, a pre-screening with a mode or system which may meet the limits in pars. (c) to (e) shall be used to verify there are no occupants in the vehicle being examined.(8) APPLICATION FOR EXEMPTIONS. Any radiation generating device user or manufacturer that cannot meet the applicable requirements of this subchapter may submit to the department a request for an exemption to the specific requirement in question. The exemption request shall demonstrate to the department all of the following: (a) That the use of the radiation generating device will not result in undue hazard to public health and safety or property.(b) That compliance would require replacement or substantial modification of the radiation generating device.(c) That the registrant will achieve, through other means, radiation protection equivalent to that required by the regulation.(d) Why the regulatory standard or requirement could not be met.Wis. Admin. Code Department of Health Services DHS 157.87
CR 01-108: cr. Register July 2002 No. 559, eff. 8-1-02; CR 09-062: am. (2) (h) Register April 2010 No. 652, eff. 5-1-10.Amended by, CR 16-078: am. (1) (intro.), r. and recr. (1) (a), cr. (1) (ag), (ar), am. (3) (b) 6., (4) (a), cr. (4) (c) to (e) Register January 2018 No. 745, eff. 2/1/2018Amended by, CR 22-015: r. and recr. Register June 2023 No. 810, eff. 7-1-23; correction in (1) (e) 1. e., (5) (c), (7) (f) 3. made under s. 35.17, Stats., Register June 2023 No. 810, eff. 7/1/2023