Or. Admin. R. 333-122-0005 - Definitions
As used in OAR chapter 333,
(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.
Notes
Statutory/Other
Statutes/Other Implemented: ORS 453.605 - 453.807
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