Statutes, codes, and regulations
Nebraska Administrative Code
HEALTH AND HUMAN SERVICES SYSTEMTitle 180 - CONTROL OF RADIATION
Chapter 8 - RADIATION SAFETY REQUIREMENTS FOR NON HEALING ARTS RADIATION GENERATING DEVICES
Section 180-8-002 - DEFINITIONS

180 Neb. Admin. Code, ch. 8, § 002

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Current through September 17, 2024
Section 180-8-002 - DEFINITIONS

The following definitions apply:

002.01ACCESSIBLE SURFACE. An accessible surface is a surface that is external or outside of the enclosure or housing provided by the manufacturer. This includes the high-voltage generator, doors, access panels, latches, control knobs, and other permanently mounted hardware and including the plane across the exterior edge of any opening.
002.02BAGGAGE UNIT. A baggage unit has the same meaning as stated in "Security Screening Unit".
002.03BEAM PORT. The beam port is the opening on the x-ray apparatus designed to emit a primary beam. This does not include openings on baggage units
002.04BOMB DETECTION RADIOGRAPHIC EQUIPMENT. Bomb detection radiographic equipment is equipment used solely for the purpose of remotely detecting explosive devices. This definition does not include hand held x-ray bomb detection equipment for the purposes of this chapter.
002.05CABINET RADIOGRAPHY. Cabinet radiography is industrial radiography using radiation machines not subject to Food and Drug Administration (FDA) performance standards for cabinet x-ray systems, in an enclosed, interlocked cabinet in which the portion of a material being irradiated is contained, and where:
(A) The radiation machine will not operate unless all openings are closed with interlocks activated;
(B) The cabinet is shielded so that every location on the exterior meets the conditions for an unrestricted area as defined in 180 NAC 4 of these regulations; and
(C) The cabinet is constructed or arranged to exclude the entrance of any part of the body of an individual during irradiation.
002.06CABINET X-RAY SYSTEM. Cabinet x-ray system has the same meaning as set out in Part 21 Code of Federal Regulations (CFR), 21 CFR § 1020.40
002.07CERTIFIED CABINET X-RAY SYSTEM. A certified cabinet x-ray system is a radiation generating device certified by the manufacturer according to 21 CFR § 1010.2 as being manufactured and assembled according to the provisions of applicable federal radiation safety performance standards 21 CFR § 1010 and 21 CFR §1020.40.
002.08CERTIFIABLE CABINET X-RAY SYSTEM. A certifiable cabinet x-ray system is an existing uncertified radiation generating device that has been modified to meet the certification requirements specified in 21 CFR § 1020.40.
002.09CLOSED-BEAM X-RAY EQUIPMENT. Closed-beam x-ray equipment is a system where the beam path cannot be entered by any part of the body during normal operation.
002.10COLLIMATOR. A collimator is a device for restricting the useful radiation in one or more directions.
002.11CONTROL PANEL. A control panel is a device containing means for regulation and activation of radiation generating equipment or for the preselection and indication of operating factors.
002.12FAIL-SAFE CHARACTERISTICS DESIGN. A fail-safe characteristics design is a design feature of a unit which causes beam port shutters to close, or otherwise prevents emergence of the primary beam, upon the failure of safety or warning devices.
002.13HAND HELD X-RAY SYSTEM. A hand held x-ray system is a portable instrument that is designed to operate when held in the hand.
002.14INDUSTRIAL RADIOGRAPHY. Industrial radiography is an examination of the structure of materials by nondestructive methods utilizing ionizing radiation to make radiographic images.
002.15INTERLOCK. An interlock is a device or engineered system that prohibits access to an area of radiation hazard either by preventing entry or by automatically removing the hazard.
002.16LEAKAGE RADIATION. Leakage radiation is all radiation coming from within the source housing, except the useful beam.
002.17LOCAL COMPONENTS. Local components are part of a radiation generating device x-ray system and includes areas that are struck by x-rays including the radiation source housing, beam port and shutter assemblies, collimators, sample holders, cameras, goniometers, detectors and shielding, but do not include power supplies, transformers, amplifiers, readout devices, and control panels.
002.18NORMAL OPERATING PROCEDURES. Normal operating procedures are step-by-step instructions necessary to accomplish the analysis. These procedures must include sample insertion and manipulation, equipment alignment, routine maintenance by the registrant, and data recording procedures which are related to radiation safety.
002.19OPEN-BEAM CONFIGURATION. An open-beam configuration is a x-ray system where an individual could place some part of their body in the primary beam path during operation.
002.20PRIMARY BEAM. The primary beam is ionizing radiation coming directly from the radiation source through a beam port into the volume defined by the collimation system.
002.21RADIATION GENERATING DEVICE (RGD). A radiation generating device is any system, device, subsystem, or component of, which may generate x-rays or particle radiation between 5 kiloelectron volt (keV) and 1 megaelectronvolt (MeV), and is not intended for healing arts use for humans or animals. Radiation generating devices (RGD) are classified in the following ways:
(A) A mobile radiation generating device is mounted on a permanent base with wheels or casters for moving while completely assembled;
(B) A portable radiation generating device is designed to be hand-carried;
(C) A stationary radiation generating device is installed or placed in a fixed location; or
(D) A transportable radiation generating device is installed in a vehicle or may be readily disassembled for transport or use in a vehicle.
002.22RADIATION SOURCE OR X-RAY TUBE HOUSING. The radiation source or x-ray tube housing is the portion of an x-ray system that contains the x-ray tube or secondary target. Often the housing contains radiation shielding material or inherently provides shielding.
002.23SAFETY DEVICE. A safety device is a device, interlock, or system that prevents the entry of any portion of an individual's body into the primary x-ray beam path or that causes the beam to be shut off upon entry into its path.
002.24SCATTERED RADIATION. Scattered radiation is radiation that has been deviated in direction, energy by passing through matter, or both.
002.25SECURITY SCREENING UNIT. A security screening unit is a non-human use x-ray system with accessible openings designed for the detection of weapons or bombs, or contraband concealed in baggage, mail, packages, or other commodities or structures.
002.26SHIELDED ROOM. A shielded room is a room housing a radiation generating device where, when the radiation generating device is set at maximum techniques, the exterior room environs meets the unrestricted area limits of 0.02 milliSievert (2 millirem) in any one hour and 1 milliSievert (100 millirem) in a year at 30 centimeters from the barrier. A shielded room does not include radiation generating equipment meeting the definition of cabinet x-ray systems.
002.27SHUTTER. A shutter is a moveable device used to block the useful or primary beam emitted from an x-ray tube assembly.
002.28SOURCE. A source is a point of origin of the radiation.
002.29WARNING DEVICE. A warning device is a visible or audible signal that warns individuals of a potential radiation hazard.
002.30X-RAY GENERATOR. A x-ray generator is a portion of an x-ray system that provides accelerating high voltage and current for the x-ray tube.

180 Neb. Admin. Code, ch. 8, § 002

Amended effective 6/26/2021