410 IAC 5-5-3.2 - Enclosed radiography; special provisions and exemptions

Authority: IC 16-41-35-26; IC 16-41-35-29

Affected: IC 16-41-35

Sec. 3.2.

(a) Systems for enclosed radiography designed to allow admittance of individuals shall:

(1) Comply with 410 IAC 5-5-11, 410 IAC 5-5-11.5, 410 IAC 5-5-12, 410 IAC 5-5-13, 410 IAC 5-5-15, 410 IAC 5-5-16, and 410 IAC 5-5-18 of 410 IAC 5-5 and 410 IAC 5-4-6.

(2) 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 board.

(3) Be evaluated at intervals not to exceed 1 year to assure compliance with the applicable requirements as specified in 410 IAC 5-5-3.2(a)(1). Records of these evaluations shall be maintained for inspection by the board for a period of 2 years after the evaluation.

(b) Cabinet x-ray systems designed to exclude individuals are exempt from the requirements of 410 IAC 5-5-3.2 except that:

(1) No registrant shall permit any individual to operate a cabinet x-ray system until such individual has received a copy of instructions in the operating procedures for the unit and has demonstrated competence in its use. Records which demonstrate compliance with this subdivision shall be maintained for inspection by the board until disposition is authorized by the board;

(2) Tests for proper operation of high radiation area control devices or alarm systems, where applicable, must be conducted and recorded in accordance with 410 IAC 5-5-11.5; and

(3) The registrant shall perform or have done an evaluation, at intervals not to exceed 1 year, to determine conformance with 410 IAC 5-4-6. If such a system is a certified cabinet x-ray system, it shall be evaluated at intervals not to exceed 1 year to determine conformance with 21 CFR 1020.40. Records of these evaluations shall be maintained for inspection by the board for a period of 2 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 board pursuant to 410 IAC 5-1-3(a).

Notes

410 IAC 5-5-3.2

Indiana State Department of Health; 410 IAC 5-5-3.2; filed Feb 29, 1984, 10:10 am: 7 IR 928; readopted filed Jul 11, 2001, 2:23 p.m.: 24 IR 4234; readopted filed May 22, 2007, 1:44 p.m.: 20070613-IR-410070141RFA; readopted filed Sep 11, 2013, 3:19 p.m.: 20131009-IR-410130346RFA Readopted filed 11/13/2019, 3:14 p.m.: 20191211-IR-410190391RFA