Utah Code R313-35-110 - Veterinary X-Ray Systems
(1)
Equipment. X-ray systems shall meet the following standards to be used for
veterinary radiographic examinations.
(a) The
leakage radiation from the diagnostic source assembly measured at a distance of
one meter may not exceed 25.8 uC/kg, 100 milliroentgens, in one hour if the
x-ray tube is operated at its leakage technique factors.
(b) Diaphragms, cones, or a stepless
adjustable collimator shall be provided for collimating the useful beam to the
area of clinical interest and shall provide the degree of protection as is
required of the diagnostic source housing.
(c) A device shall be provided to terminate
the exposure after a preset time or exposure.
(d) A "dead-man" type exposure switch shall
be provided, together with an electrical cord of sufficient length, so that the
operator may stand out of the useful beam and at least six feet from the animal
during x-ray exposures.
(e) For
stationary or mobile x-ray systems, a method shall be provided for visually
defining the perimeter of the x-ray field. The total misalignment of the edges
of the visually defined field with the respective edges of the x-ray field
along either the length or width of the visually defined field may not exceed
6% of the distance from the source to the center of the visually defined field
if the surface that it appears on is perpendicular to the axis of the x-ray
beam.
(f) For portable x-ray
systems, a method shall be provided to align the center of the x-ray field with
respect to the center of the image receptor to within 6% of the source to image
receptor distance, and to show the source to image receptor distance to within
6%.
(g) X-ray equipment designed
for human radiographic examinations that is being used for veterinary
radiographic examinations shall be FDA approved for use in the United States
and shall be certified in accordance with
21 CFR
1010.2 and identified in accordance with
21 CFR
1010.3.
(h) If directed by the director an x-ray
machine that does not meet the requirements of Section
R313-35-110 may not be operated
for diagnostic purposes.
(2) Structural shielding. For stationary
x-ray systems, the wall, ceiling, and floor areas shall provide enough
shielding to meet the requirements of Section
R313-15-301.
(a) Registrants using computed tomography or
fluoroscopic imaging assemblies shall comply with Section
R313-28-32.
(3) Operating procedures. The registrant
shall be responsible for directing the operation of the x-ray machines that are
under the registrant's administrative control. The registrant or registrant's
agent shall assure that the requirements of Subsections
R313-35-110(3)(a)
through R313-35-110(3)(g)
are met in the operation of the x-ray machines.
(a) If feasible, the operator shall stand
well away from the useful beam and the animal during radiographic
exposures.
(b) In applications
where the operator is not located beyond a protective barrier, clothing
consisting of a protective apron having a lead equivalent of not less than 0.5
millimeters shall be worn by the operator and other individuals in the room
during exposures.
(c) An individual
other than the operator may not be in the x-ray room while exposures are being
made unless the individual's assistance is required.
(d) If the animal must be held by an
individual, that individual shall be protected with appropriate shielding
devices, for example, protective gloves and apron. The individual shall be so
positioned that no unshielded part of that individual's body will be struck by
the useful beam.
(e) Individuals
who will be operating the x-ray equipment shall be instructed in the
registrant's written radiation safety program and be qualified in the safe use
of the equipment.
(f) Facilities
shall have protective aprons and gloves available in sufficient numbers to
provide protection to personnel who are involved with x-ray operations and who
are otherwise not shielded.
(g)
Personnel monitoring. Individuals who are associated with the operation of an
x-ray system are subject to the applicable requirements of Rule
R313-15.
(4) Maintenance
of records and information. The registrant shall maintain at least the
information listed in Subsections
R313-35-110(4)(a)
and R313-35-110(4)(b)
for each x-ray machine:
(a) serial numbers;
and
(b) records of surveys or
calculations to demonstrate compliance with Section
R313-15-302, calibration,
maintenance, and modifications performed on the x-ray machine.
(5) Hand-held x-ray systems. X-ray
equipment designed to be hand-held shall comply with Section
R313-35-110, excluding
Subsection R313-35-110(5)
and Section R313-28-52.
(a) In addition to the dose limits in Section
R313-15-301, operators of
hand-held x-ray equipment shall ensure that members of the public that may be
exposed to scatter radiation or primary beam transmission from the hand-held
device are not exposed above two milliroentgen per hour.
(b) Operators will ensure that members of the
public likely to be exposed to greater than two milliroentgen per hour will be
provided protective aprons of at least 0.5 millimeter lead equivalence or are
moved to a distance where the exposure rate to the individual is below two
milliroentgen per hour.
Notes
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No prior version found.