Current through Register Vol. 50, No. 9, September 20, 2024
A. Systems for
enclosed radiography designed to allow admittance of individuals shall:
1. comply with all applicable requirements of
this Chapter and LAC 33:XV.421, and if such system is a certified cabinet X-ray
system, it shall comply with all applicable requirements of this Chapter and
21 CFR
1020.40; and
2. be evaluated at intervals not to exceed
one year to assure compliance with the applicable requirements as specified in
LAC 33:XV.589.A.1. Records of these evaluations shall be maintained for
inspection by the department for a period of two consecutive years after the
evaluation.
B. Enclosed
X-ray systems designed to exclude individuals are exempt from the requirements
of this Chapter except as follows:
1.
operating personnel must be provided with either a film badge or a
thermoluminescent dosimeter, and reports of the results must be maintained for
inspection by the department;
2. no
registrant shall permit any individual to operate an enclosed X-ray system
until such individual has received a copy of and instructions in the operating
procedures for the unit and has demonstrated competence in its use. Records
that demonstrate compliance with this Section shall be maintained for
inspection by the department until disposition is authorized by the
department;
3. tests for proper
operation of high radiation area control devices or alarm systems, where
applicable, must be conducted and recorded in accordance with LAC 33:XV.548;
and
4. the registrant shall perform
an evaluation, at intervals not to exceed one year, to determine conformance
with LAC 33:XV.421. If such system is a certified X-ray system, it shall be
evaluated at intervals not to exceed one year to determine conformance with
21 CFR
1020.40. Records of these evaluations shall
be maintained for inspection by the department for a period of two consecutive
years after the evaluation.
C. Certified cabinet X-ray systems shall be
maintained in compliance with
21 CFR
1020.40 unless prior approval has been
granted by the administrative authority pursuant to LAC 33:XV.103.A.
D. No registrant may modify a cabinet X-ray
system without prior approval of the administrative authority pursuant to LAC
33:XV.103.A.
AUTHORITY NOTE:
Promulgated in accordance with
R.S.
30:2001 et
seq.
