10-144-220 Me. Code R. § H-2
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:
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.
10-144 C.M.R. ch. 220, § H-2