Oregon Administrative Rules › Chapter 333 - OREGON HEALTH AUTHORITY, PUBLIC HEALTH DIVISION › Division 122 - RADIATION SAFETY REQUIREMENTS FOR INDUSTRIAL X-RAY MACHINE OPERATIONS › Section 333-122-0005 - Definitions

Current through Register Vol. 63, No. 7, July 1, 2024
As used in OAR chapter 333, division 122, the following
				definitions apply:
(1) "Analytical
			 X-ray equipment" means equipment that generates (by electronic means) and uses
			 ionizing radiation for the purpose of examining the microstructure of
			 materials, diffraction, and spectroscopy (including fluorescence).
(2) "Annual refresher safety training" means
			 a review conducted or provided by the registrant for its employees on radiation
			 safety aspects of RGD X-ray. The review must include, at a minimum, a review of
			 radiation safety aspects of the RGD X-ray machine, any results of internal
			 audits, Authority inspections, new procedures or equipment, new or revised
			 regulations, and accidents or errors that have occurred. The review must also
			 provide opportunities for employees to ask safety questions.
(3) "ANSI" means the American National
			 Standards Institute.
(4) "Cabinet
			 radiography" means industrial radiography conducted in an enclosure or cabinet
			 so shielded that every location on the exterior meets the dose limits for
			 individual members of the public as specified in OAR 333-120-0180.
(5) "Cabinet X-ray system" means an X-ray
			 system with the X-ray tube installed in an enclosure, hereinafter termed a
			 cabinet that is independent of existing architectural structures except the
			 floor. The cabinet X-ray system 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. This definition
			 includes X-ray systems designed primarily for the inspection of carry-on
			 baggage at airline, railroad and bus terminals and in similar facilities, and
			 all X-ray systems designed primarily for the inspection of letters, periodicals
			 and packages in mailrooms. 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.
(6) "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
			 1020.40.
(7) "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 pursuant to the provisions of
			 21 CFR
			 1020.40.
(8) "Fail-safe characteristics" means design
			 features which cause beam port shutters to close, or otherwise prevent
			 emergence of the primary beam, upon the failure of a safety or warning
			 device.
(9) "Hands-on experience"
			 means experience in all areas considered to be directly involved in the X-ray
			 process, and includes taking radiographs, calibration of survey instruments,
			 operational and performance testing of survey instruments and devices, film
			 development, posting of radiation areas, set-up of X-ray equipment, and
			 radiation surveys, as applicable. Trainees undergoing the "hands-on experience"
			 must do so under the direct supervision of a qualified RGD X-ray machine
			 operator.
(10) "Hybrid Gauge" means
			 a gauging device utilizing both X-ray and radioactive material
			 sources.
(11) "Industrial X-ray"
			 means a nondestructive examination of the structure of materials using an X-ray
			 machine to make radiographic images.
(12) "Local components" means part of an RGD
			 X-ray system with areas being struck by X-rays such as the radiation source
			 housings, port and shutter assemblies, collimators, sample holders, cameras,
			 goniometers, detectors and shielding. This does not include the power supplies,
			 transformers, amplifiers, readout devices and control panels.
(13) "Normal operating procedures" means
			 step-by-step instructions necessary to accomplish the analysis. The
			 instructions will outline procedures that include sample insertion and
			 manipulation, equipment alignment, routine maintenance by the registrant or
			 licensee and data recording procedures which are related to radiation safety.
(14) "Open-beam configuration"
			 means an RGD X-ray system in which an individual could accidentally place a
			 part of their body in the primary beam path during normal operation.
(15) "Permanent X-ray radiography
			 installation" means an enclosed shielded room, cell, or vault in which RGD
			 X-ray is performed.
(16) "Practical
			 examination" means a demonstration through application of the safety rules and
			 principles in RGD X-ray to include the use of all procedures and equipment to
			 be used by RGD X-ray personnel.
(17) "Primary beam" means ionizing radiation
			 which passes through the aperture of the source housing by a direct path from
			 the X-ray tube or a radioactive source located in the radiation source housing.
(18) "RGD" means radiation
			 generating devices that produce X-rays used in the non-healing arts
			 environments.
(19) "RGD X-ray
			 operations" means all activities performed with an RGD X-ray machine.
			 Activities include using, setting up equipment, and any activity inside the
			 restricted area boundaries.
(20)
			 "RGD operator" means any individual who handles, adjusts technique factors,
			 activates the exposure switch or button on an RGD X-ray machine and is
			 qualified under OAR 333-122-0160.
(21) "RGD X-ray personnel" means any X-ray
			 operator, X-ray instructor or X-ray trainee.
(22) "Radiation safety officer for RGD X-ray"
			 means an individual with the responsibility for the overall radiation safety
			 program on behalf of the registrant as outlined in OAR 333-122-0010.
(23) "Shielded room X-ray using X-ray
			 machines" means an enclosed room or vault in which RGD X-ray is performed
			 within the interior and is not occupied during X-ray operations. The room must
			 be shielded so that every location surrounding the exterior meets conditions
			 for an unrestricted area as specified in OAR 333-120-0180, and the only access
			 is through openings that are interlocked so that the X-ray machine will not
			 operate unless all openings are securely closed.
(24) "Supervision" means the supervising
			 individual routinely reviews and monitors the work being performed. See OAR
			 333-106-0005  for definition of general, direct and personal supervision. (25)
			 "X-ray gauge" means an X-ray producing device designed and manufactured for the
			 purpose of detecting, measuring, gauging or controlling thickness, density, or
			 interface location.
(25) "X-ray
			 operator's assistant" means any individual who, under the direct supervision of
			 an RGD X-ray operator, uses radiographic X-ray machines, related handling tools
			 or radiation survey instruments in RGD X-ray.
Statutory/Other Authority: ORS
				  453.605  - 453.807
Statutes/Other Implemented: ORS
				  453.605  - 453.807