Current through Register Vol. 43, No. 52, December 26, 2024
(a) Each licensee
or registrant shall ensure that each system for enclosed radiography that is
designed to allow the admittance of any individual meets the following
requirements:
(1) Meets all applicable
requirements of this part and
K.A.R.
28-35-214a if the system is not a certified
cabinet X-ray system;
(2) meets all
applicable requirements of this part and has been certified by the U.S. food
and drug administration (FDA) as compliant with the requirements in
21 C.F.R.
1020.40, if the system is a certified cabinet
X-ray system; and
(3) is evaluated,
at intervals not to exceed one year, to ensure compliance with the applicable
requirements specified in paragraphs (1) or (2) of this subsection. A record of
each evaluation shall be maintained for two years after the
evaluation.
(b) Each
cabinet X-ray system designed to exclude any individual shall be exempt from
the requirements of
K.A.R.
28-35-276,
K.A.R.
28-35-278,
K.A.R.
28-35-281,
K.A.R.
28-35-282,
K.A.R.
28-35-283,
K.A.R.
28-35-284,
K.A.R.
28-35-285,
K.A.R.
28-35-286, and
K.A.R.
28-35-289, with the following exceptions:
(1) Operating personnel shall be provided
with personnel-monitoring equipment as specified in
K.A.R.28-35-217a.
(2) A registrant shall not permit any
individual to operate a cabinet x-ray system until that individual has received
a copy of and instruction in the operating procedures for the unit and has
demonstrated competence in its use. A record that demonstrates compliance with
this paragraph shall be maintained for inspection by the department until
disposition is authorized by the department.
(3) A test for proper operation of each
high-radiation area control device or alarm system, where applicable, shall be
conducted and recorded as specified in K.A.R. 28-35-288.
(c) Each permanent radiographic installation
having any high-radiation area entrance control of the type specified in
K.A.R.
28-35-219a shall also meet the following
requirements:
(1) Each entrance that is used
for personnel access to the high-radiation area in a permanent radiographic
installation shall have both a visible and an audible warning signal to warn of
the presence of radiation.
(2) The
visible signal shall be activated by radiation whenever the source is exposed.
The audible signal shall be activated if an attempt is made to enter the
installation while the source is exposed.
(d) The control device or alarm system shall
be tested for proper operation at the beginning of each period of use. A record
of each test shall be prepared quarterly or before the first use after the end
of the quarter. Each record shall be maintained for inspection by the
department until the secretary authorizes disposal of the
record.
