Code of Maine Rules › 10 - DEPARTMENT OF HEALTH AND HUMAN SERVICES › 144 - DEPARTMENT OF HEALTH AND HUMAN SERVICES - GENERAL › Chapter 220 - Rules Relating to Radiation Protection › Part H - RADIATION SAFETY REQUIREMENTS FOR ANALYTICAL AND OTHER INDUSTRIAL RADIATION MACHINES › Section 144-220-H-2 - Definitions

Current through 2024-29, July 17, 2024
As used in this Part, the following definitions
					 apply:
Analytical radiation machine
includes, but is
					 not limited to, x-ray diffraction, fluorescence analysis, spectroscopy, or
					 particle size analysis.
Cabinet x-ray system
means an x-ray system
					 with the x-ray tube installed in an enclosure independent of existing
					 architectural structures except the floor on which it may be placed. An x-ray
					 tube used within a shielded part of a building, or x-ray equipment that may
					 temporarily or occasionally incorporate portable shielding, is not considered a
					 cabinet x-ray system. The cabinet x-ray system is intended to:
(a) Contain at least that portion of a
				  material being irradiated;
(b)
				  Provide radiation attenuation; and
(c) Exclude personnel from its interior
				  during generation of radiation.
Certifiable cabinet x-ray system
means an
					 existing uncertified x-ray system that has been modified to meet the
					 certification requirements specified in
					 21 CFR Parts
					 1010 through
					 1020.
Certified cabinet x-ray system
means an x-ray
					 system that has been certified in accordance with
					 21 CFR
					 1010.2 as being manufactured and assembled on
					 or after April 10, 1975, according to the provisions of
					 21 CFR
					 1020.40.
Fail-safe characteristics
mean a design
					 feature, which causes beam port shutters to close, or otherwise prevent
					 emergence of the primary beam, upon the failure of a safety or warning
					 device.
Fluoroscopic imaging assembly
means a
					 subsystem in which x-ray photons produce a fluoroscopic image. It includes the
					 image receptors such as the image intensifier and spot-film device, electrical
					 interlocks, if any, and structural material providing linkage between the image
					 receptor and source assembly.
Local components
mean part of an x-ray system
					 and include areas that are struck by x-rays such as radiation source housings,
					 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.
Normal operating procedures
mean step-by-step
					 instructions necessary to accomplish the analysis. These procedures shall
					 include, sample insertion and manipulation, equipment alignment, routine
					 maintenance by the registrant or licensee, and data recording procedures, which
					 are related to radiation safety.
Open-beam configuration
means a radiation
					 machine in which an individual could accidentally place some part of his body
					 in the primary beam path during normal operation.
Other industrial radiation machine
includes,
					 but is not limited to, x-ray equipment (including cabinet x-ray equipment) used
					 for cathodoluminescence, ion implantation, gauging, or electron beam
					 welding.
Primary beam
means radiation which passes
					 through an aperture of the source housing by a direct path from the x-ray tube
					 or a radioactive source located in the radiation source housing.
Safety device
means a device 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.
X-ray system
means a group of components
					 utilizing x-rays to determine the elemental composition or to examine the
					 microstructure of materials.