Subchapter A. GENERAL PROVISIONS
Sec.
227a.1. Purpose and scope.
227a.2. Definitions.
227a.3. Exemptions.
227a.4. Application for exemptions.§ 227a.1. Purpose and scope.
(a) This chapter establishes special requirements for non-healing arts radiation-producing devices operating between 5 kiloelectron volts (keV) and 1 million electron volts (MeV). This chapter shall apply to all devices defined in § 227a.2 (relating to definitions). Machines operating at energies greater than 1 MeV are subject to Chapter 228 (relating to radiation safety requirements for particle accelerators).
(b) In addition to this chapter, all registrants are subject to Chapters 215, 216, 219 and 220. This chapter does not pertain to radiation safety requirements for X-ray equipment covered under Chapters 221 and 225 (relating to X-rays in the healing arts; and radiation safety requirements for industrial radiographic operations) and Chapter 228.
(c) Radiography that meets the definition of ‘‘cabinet radiography,’’ including cabinet X-ray systems, is regulated under this chapter.
(d) Radiography that occurs in a ‘‘shielded room’’ is regulated under this chapter.
(e) Radiography equipment that meets the definition of ‘‘bomb detection radiation-producing devices’’ is regulated under this chapter.
(f) Industrial radiography that is open-beam, and not in a shielded room and not otherwise listed here, is regulated under Chapter 225.
§ 227a.2. Definitions.
The following words and terms, when used in this chapter, have the following meanings unless the context clearly indicates otherwise:
ALARA—As low as reasonably achievable.
Accessible surface—The external or outside surface of the enclosure or housing provided by the manufacturer. The term includes the high-voltage generator, doors, access panels, latches, control knobs and other permanently mounted hardware, including the plane across the exterior edge of any opening.
Beam port—An opening on the X-ray apparatus designed to emit a primary beam. This term does not include an opening on a security screening device.
Bomb detection radiation-producing device—X-ray-generating equipment used solely for the purpose of remotely detecting explosive devices. For the purposes of this chapter, this term does not include hand-held X-ray bomb detection devices.
Cabinet radiography—Industrial radiography using radiation-producing devices not subject to United States Food and Drug Administration performance standards for cabinet X-ray systems, in an enclosed, interlocked cabinet in which the portion of a material being irradiated is contained, and in which all of the following are met:(i) The radiation-producing device will not operate unless all openings are closed with interlocks activated.
(ii) The cabinet is shielded so that every location on the exterior meets the conditions for an unrestricted area as defined under 10 CFR 20.1003 (relating to definitions).
(iii) The cabinet is constructed or arranged as to exclude the entrance of any part of the body of an individual during irradiation.
Cabinet X-ray system—An X-ray system with the X-ray tube installed in an enclosure which, independently of existing architectural structures except the floor on which it may be placed, is intended to contain at least that portion of a material being irradiated, provide radiation attenuation and exclude personnel from its interior during generation of radiation. The term does not include an X-ray tube used within a shielded part of a building, or X-ray equipment which may temporarily or occasionally incorporate portable shielding.
Cathode ray tube—A device used to accelerate electrons for demonstration or research purposes, except where the tube is incorporated into a television or display monitor that is subject to, and has met applicable Federal radiation safety performance standards under 21 CFR Part 1010 (relating to performance standards for electronic products: general) and 21 CFR 1020.10 (relating to television receivers).
Certified cabinet X-ray system—A radiation-producing device certified by the manufacturer under 21 CFR 1010.2 (relating to certification) as being manufactured and assembled under the provisions of applicable Federal radiation safety performance standards under 21 CFR Part 1010 and 21 CFR 1020.40 (relating to cabinet X-ray systems).
Closed-beam radiation-producing device—A device in which the beam path cannot be entered by any part of the body during normal operation.
Cold-cathode gas discharge tube—An electronic device in which electron flow is produced and sustained by ionization of contained gas atoms and ion bombardment of the cathode.
Collimator—A device for restricting the useful radiation in one or more directions.
Control panel—A device containing means for regulation and activation of a radiation-producing device or for the preselection and indications of operating factors.
Electron microscope—Equipment using the wave characteristics of electrons that have been accelerated by an electric field to visualize the microscopic structure of material.
Emergency procedure—The written planned steps to be taken in the event of actual or suspected exposure of an individual in excess of an administrative or regulatory limit, including the names and telephone numbers of individuals to be contacted as well as directives for processing the film badge or other personnel monitoring devices.
Fail-safe design—A design in which all realistically anticipated failures of indicators or safety components result in a condition in which individuals are safe from exposure to radiation. For example, the production of X-rays must be prevented if a light indicating ‘‘X-RAY ON’’ fails and the shutter must close if a shutter status indicator fails.
General-use system—An individual screening system that delivers an effective dose equal to or less than 25 µrem (0.25 µSv) per screening.
Handheld radiation-producing device—A portable device designed to operate when held in the hand, such as a hand-held X-ray fluorescence analytical device.
Industrial radiography—An examination of the structure of materials by nondestructive methods, utilizing ionizing radiation to make radiographic images.
Interlock—A device or engineered system that precludes access to an area of radiation hazard either by preventing entry or by automatically removing the hazard.
kV—Kilovolt.
Leakage radiation—Radiation coming from within the source housing, other than the useful beam.
Limited-use system—An individual screening system that is capable of delivering an effective dose greater than 25 µrem (0.25 µSv) per screening but that cannot exceed an effective dose of 1 mrem (10 µSv) per screening.
Local components—Parts of a radiation-producing device X-ray system, including areas struck by X-rays, such as radiation source housings, beam port and shutter assemblies, collimators, sample holders, cameras, goniometers, detectors and shielding. The term does not include power supplies, transformers, amplifiers, readout devices or control panels.
Lockout/tagout—A safety procedure that ensures dangerous devices and energy sources are properly shut off and cannot startup unexpectedly while maintenance or service work is being completed.
µrem—Microrem.
µSv—Micro Sievert.
mrem—Millirem.
mSv—Milli Sievert.
Mobile device—Radiation-producing device mounted on a permanent base with wheels or casters, or both, for moving while completely assembled.
Normal operating procedures—Step-by-step instructions necessary to accomplish the task. Examples include sample insertion and manipulation, equipment alignment, routine maintenance by the registrant and data recording procedures, which are related to radiation safety.
Open-beam radiation-producing device—A device in which any part of the body could enter the beam path during normal operations. Examples include X-ray gauges, tabletop and handheld X-ray devices and electron beam welders.
Permanent radiographic installation—A shielded installation or structure designed or intended for radiography in which radiography is regularly performed.
Portable device—Radiation-producing device designed to be hand-carried.
Primary beam—The ionizing radiation coming directly from the radiation source through a beam port into the volume defined by the collimation system.
Qualified expert—The term has the meaning given to it under § 215.2 (relating to definitions).
RSO—radiation safety officer—The term has the meaning given to it under § 215.2.
Radiation-producing device—A radiation-producing device where the apparatus, device, electronic product, system, subsystem or component of any of them may generate X-rays or particle radiation between 5 keV and 1 MeV. The device is not intended for healing arts use for humans or animals. The device is fixed or portable, such as mobile devices, portable devices, stationary equipment or transportable equipment.
Radiation-producing device used in individual security screening—X-ray equipment used on humans for security evaluation.
Radiation source (or X-ray tube) housing—That portion of an X-ray system that contains the X-ray tube or secondary target, or that contains both. Often the housing contains radiation shielding material or inherently provides shielding.
Radiograph—A permanent film or digital image produced on a sensitive surface by a form of radiation other than direct visible light.
Radiography—The process of creating a radiographic image through X-ray radiation.
Registrant—The term has the meaning given to it under § 215.2.
Safety device—A device, interlock or system that prevents the entry of any portion of an individual’s body into the primary X-ray beam or that causes the beam to shut off upon entry into its path.
Scattered radiation—Radiation that has been deviated in direction or energy, or both, by passing through matter.
Security screening device—A non-human use open-beam system or cabinet X-ray system with accessible openings designed for the detection of weapons, bombs or contraband concealed in baggage, mail, a package or another commodity or structure.
Shielded room—A room housing a non-healing arts radiation-producing device where, with the radiation-producing device at maximum techniques, the exterior room environs meet the unrestricted area limits of 2 mrem (0.02 mSv) in any 1 hour and 100 mrem (1 mSv) in a year at 30 centimeters from the barrier. The term does not include a room housing a radiation-producing device that meets the definition of cabinet X-ray systems.
Shutter—A moveable device used to block the useful (or primary) beam emitted from an X-ray tube assembly.
Source—The point of origin of the radiation. An example of this term is the focal spot of an X-ray tube.
Stationary equipment—Radiation-producing device equipment that is installed or placed in a permanent or fixed location.
Transportable equipment—Radiation-producing device equipment to be installed in a vehicle or that may be readily disassembled for transport or use in a vehicle.
Warning device—A visible or audible signal that warns individuals of a potential radiation hazard.
X-ray gauge—An X-ray-producing device designed and manufactured for the purpose of detecting, measuring, gauging, or controlling thickness, density, level or interface location.
X-ray generator—That portion of an X-ray system which provides the accelerating high voltage and current for the X-ray tube.
X-ray tube—The term has the meaning given to it under § 221.2 (relating to definitions).
Cross References This section cited in 25 Pa. Code § 227a.1 (relating to purpose and scope).
§ 227a.3. Exemptions.
(a) A radiation-producing device meeting the definition of ‘‘bomb detection radiation-producing device’’ is exempt from § 227a.16 (relating to posting).
(b) Unless used in a dedicated location, a handheld radiation-producing device is exempt from § 227a.16.
(c) The following devices and equipment are exempt from this chapter:
(1) Domestic television receivers, if the exposure rate at 5 centimeters from any outer surface is less than 0.5 mrem (0.005 mSv) per hour.
(2) Cold-cathode gas discharge tubes, if the exposure rates do not exceed 10 mrem (0.1 mSv) per hour at 30 centimeters from any point on the external surface of the tube.
(3) Other electrical equipment, except electron microscopes, that produces radiation incidental to its operation for other purposes, if the dose rate to the whole body at the point of nearest approach to the equipment when any external shielding not integral to the equipment is removed does not exceed 25 mrem (0.25 mSv) per year. The product testing of any radiation-producing device or factory servicing of the equipment is not exempt.
(d) Equipment described in this section is not exempt from this chapter if it is used or handled in a manner an individual might receive a dose of radiation in excess of the limits specified in Chapter 219 (relating to standards for protection against radiation).
(e) Equipment operating at less than or equal to 50 kV tube voltage and designed to be held by an operator during use is exempt from this chapter except for § § 227a.12 and 227a.21 (relating to labeling; and instruction and training).
§ 227a.4. Application for exemptions.
The Department may consider an application for exemptions to the requirements of this chapter. A radiation-producing device registrant who cannot meet one or more requirements of this chapter shall submit to the Department a written request for an exemption to the requirements that cannot be met. The exemption request must explain why the provision cannot be met and must demonstrate all of the following to the Department’s satisfaction:
(1) That the use of the radiation-producing device will not result in undue hazard to public health and safety or to property.
(2) That compliance with the provision from which the registrant is seeking exemption would require replacement or substantial modification of the radiation-producing device.
(3) That the registrant will achieve, through other means, radiation protection equivalent to that required by the provision from which the registrant is seeking exemption.
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