LAC 33:XV.589. Special Requirements and Exemptions for Enclosed Radiography

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.