Statutes, codes, and regulations
Maine Administrative Code
Department 10 - DEPARTMENT OF HEALTH AND HUMAN SERVICESDivision 144 - DEPARTMENT OF HEALTH AND HUMAN SERVICES - GENERALChapter 220 - Rules Relating to Radiation ProtectionPart E - RADIATION SAFETY REQUIREMENTS FOR INDUSTRIAL RADIOGRAPHIC OPERATIONS
Subpart F - NOTIFICATIONS
Section 144-220-E-F-43 - Special requirements and exemptions for radiation machines in enclosed radiography

10-144-220 Me. Code R. § E-F-43

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Current through 2024-51, December 18, 2024
Section 144-220-E-F-43 - Special requirements and exemptions for radiation machines in enclosed radiography
A. Systems for enclosed radiography, including shielded-room radiography and cabinet x-ray systems not otherwise exempted, designed to allow admittance of individuals shall:
(1) Comply with all applicable requirements of this Part and D.1201 of this rule. If such a system is a certified cabinet x-ray system, it shall comply with all applicable requirements of this Part, Part H and 21 CFR 1020.40.
(2) Be evaluated at intervals not to exceed one year to assure compliance with the applicable requirements as specified in E.24. Records of these evaluations shall be maintained for inspection by the Agency for a period of two years after the evaluation.
B. Certified and uncertified cabinet x-ray systems designed to exclude individuals are exempt from the requirements of this Part except that:
(1) Operating personnel must be provided with an individual monitoring device and reports of the results must be maintained for inspection by the Agency.
(2) No registrant shall permit any individual to operate a cabinet x-ray system until such individual has received a copy of and instruction in the operating procedures for the unit and has demonstrated competence in its use. Records, which demonstrate compliance with this section shall be maintained for inspection by the Agency until disposition is authorized by the Agency.
(3) Tests for proper operation of high radiation area control devices, interlocks, or alarm systems, where applicable, must be conducted and recorded in accordance with E.25.
(4) The registrant shall perform an evaluation, at intervals not to exceed one year, to determine conformance with D.1201 of this rule. 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 Agency for a period of two 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 Agency pursuant to A.3(a) of this rule.

10-144 C.M.R. ch. 220, § E-F-43