Special Requirements and Exemptions for Enclosed Radiography

(A) Systems for enclosed radiography, including shielded-room radiography and cabinet x-ray systems not otherwise exempted, shall comply with all applicable requirements of 105 CMR 120.300. (B) Systems for enclosed radiography designed to allow admittance of individuals shall be evaluated at intervals not to exceed one year to ensure compliance with the applicable requirements of 105 CMR 120.300, 120.221(A) and 120.222. Records of these evaluations shall be maintained for Agency inspection for five years after the evaluation. (C) Certified cabinet x-ray systems are exempt from the requirements of 105 CMR 120.300 except that: (1) The registrant shall comply with the requirements of 105 CMR 120.020 and 120.200. (2) Tests for proper operation of interlocks must be conducted and recorded in accordance with 105 CMR 120.319. Records of these tests shall be maintained for Agency inspection until disposal is authorized by the Agency. (3) The registrant shall perform an evaluation to determine compliance with 21 CFR 1020.40 at intervals not to exceed one year. Records of these evaluations shall be maintained for Agency inspection for five years after the evaluation. (D) Certified cabinet x-ray systems shall be maintained in compliance with 21 CFR 1020.40 and no modification may be made to the system unless prior agency approval has been granted by the Agency pursuant to 105 CMR 120.020.