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. DHS 157.87(3)(f)(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. DHS 157.87(3)(g)(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. DHS 157.87(3)(h)(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. DHS 157.87(3)(i)(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: DHS 157.87(3)(i)1.1. 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. DHS 157.87(3)(i)2.2. 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. DHS 157.87(3)(i)3.3. 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. DHS 157.87(3)(i)4.4. Maintain surveillance of the exposure area during operation, either visually or by other reliable means to ensure that no person enters the area. DHS 157.87(3)(i)5.5. 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. DHS 157.87(3)(i)6.6. 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: DHS 157.87(3)(i)6.a.a. Is appropriately designed and calibrated for the type of x-ray emitted, such as pulse or continuous. DHS 157.87(3)(i)6.b.b. Is set at an appropriate level to detect the presence of the radiation source, for example 0.02 mSv (2 mrem) per hour. DHS 157.87(3)(i)7.7. 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. DHS 157.87(3)(i)8.8. 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. DHS 157.87(3)(i)9.9. 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. DHS 157.87(3)(j)(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: DHS 157.87(3)(j)3.3. Radiation protection concepts of time, distance, shielding, and ALARA. DHS 157.87(3)(k)(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: DHS 157.87(3)(k)1.1. Personnel working with or routinely working near and having potential for exposure to, the primary beam of an open-beam radiation generating device. DHS 157.87(3)(k)2.2. 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. DHS 157.87(4)(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: DHS 157.87(4)(a)(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: DHS 157.87(4)(a)3.3. 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. DHS 157.87(4)(a)4.4. The operator will not aim the primary beam at themselves or at any individual during operation of the radiation generating device. DHS 157.87(4)(a)5.5. Operator radiation exposure is as low as reasonably achievable, for example, by use of ancillary equipment that will reduce exposure. DHS 157.87(4)(b)(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. DHS 157.87(4)(c)(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. DHS 157.87(4)(d)(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. DHS 157.87(5)(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: DHS 157.87(5)(a)(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). DHS 157.87(5)(b)(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. DHS 157.87(5)(c)(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). DHS 157.87(5)(d)(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. DHS 157.87(5)(e)(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. DHS 157.87(5)(f)(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. DHS 157.87(5)(g)(g) Separate electrical systems. The interlock system and the emergency shut-off system shall be separate electrical and mechanical systems. DHS 157.87(5)(h)(h) Egress from shielded room. A person within the room housing a radiation generating device shall be able to egress at all times. DHS 157.87(5)(i)1.1. 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. DHS 157.87(5)(i)2.2. 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: DHS 157.87(5)(i)2.a.a. Personnel devices are to be checked daily for proper operation and a record of this check is maintained. DHS 157.87(5)(i)2.b.b. The personnel device is designed to clearly indicate entry into a 0.02 mSv (2 mrem) per hour or greater radiation field. DHS 157.87(5)(i)2.c.c. All personnel working with the radiation generating device are provided with a personnel device. DHS 157.87(5)(i)3.3. 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: DHS 157.87(5)(i)3.a.a. Stationary detection devices are checked daily for proper operation and a record of this check is maintained. DHS 157.87(5)(i)3.b.b. The stationary device is designed to clearly indicate entry into a 0.02 mSv (2 mrem) per hour or greater radiation field. DHS 157.87(5)(i)3.c.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. DHS 157.87(5)(j)(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. DHS 157.87(5)(k)(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. DHS 157.87(5)(L)(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. DHS 157.87(5)(m)(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. DHS 157.87(6)(6) Bomb detection radiographic equipment. In addition to the requirements of sub. (1), all of the following requirements apply to bomb detection radiographic equipment: DHS 157.87(6)(a)(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). DHS 157.87(6)(b)(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. DHS 157.87(6)(c)(c) Area control. The registrant shall provide security to prevent entry by individuals from any point when the machine is energized during training. DHS 157.87(7)(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: DHS 157.87(7)(a)(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. DHS 157.87(7)(b)(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. DHS 157.87(7)(c)(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). DHS 157.87(7)(d)(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: DHS 157.87(7)(d)1.1. Used only when the additional radiation is required to create the image. DHS 157.87(7)(e)(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. DHS 157.87(7)(f)1.1. 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). DHS 157.87(7)(f)2.2. 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. DHS 157.87(7)(f)3.3. 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. DHS 157.87(8)(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: DHS 157.87(8)(a)(a) That the use of the radiation generating device will not result in undue hazard to public health and safety or property. DHS 157.87(8)(b)(b) That compliance would require replacement or substantial modification of the radiation generating device. DHS 157.87(8)(c)(c) That the registrant will achieve, through other means, radiation protection equivalent to that required by the regulation.
/code/admin_code/dhs/110/157
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administrativecode
/code/admin_code/dhs/110/157/ix/87/3/j/5
Department of Health Services (DHS)
Chs. DHS 110-199; Health
administrativecode/DHS 157.87(3)(j)5.
administrativecode/DHS 157.87(3)(j)5.
section
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