Kan. Admin. Regs. § 28-35-288

Current through Register Vol. 43, No. 49, December 5, 2024

Section 28-35-288 - Special requirements and exemptions for enclosed radiography

(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.

Kan. Admin. Regs. § 28-35-288

Authorized by and implementing K.S.A. 48-1607; effective Jan. 1, 1970; amended, T-85-43, Dec. 19, 1984; amended May 1, 1985; amended Sept. 20, 1993; amended Dec. 30, 2005; amended by Kansas Register Volume 37, No. 16; effective 5/4/2018.