Ariz. Admin. Code § 9-7-206

Current through Register Vol. 30, No. 50, December 13, 2024

Section R9-7-206 - Assembly, Installation, Removal from Service, and Transfer

A. A person who assembles, or installs ionizing radiation machinesin this state shall notify the Department in writing within 15 days of:

1. The name and address of the person possessing the machine that was assembled or installed;

2. The manufacturer, model, and serial number of each radiation machine with the tube housing model number and serial number, maximum kVp, and maximum mA, assembled or installed; and

3. The date each machine was assembled or installed, or the first clinical procedure is performed.

B. Any person who possesses a radiation machine registered by the Department shall notify the Department within 15 days of the machine being taken out of service. The written notification shall contain the name and address of the person receiving the machine, if it is sold, leased, or transferred to another person; the manufacturer, model, and serial number of the machine; and the date the machine was taken out of service.

C. In the case of diagnostic x-ray systems that contain certified components, an assembler shall, within 15 days following completion of the assembly, submit to the Department a copy of the assembler's report (FDA Report No. 2579) prepared in compliance with requirements in 21 CFR 1020.30(d), revised April 1, 2008, incorporated by reference, and available under R9-7-101. This incorporated material contains no future editions or amendments. The report shall suffice in lieu of any other report by the assembler, if it contains the information required in subsection (A).

D. A person shall not make, sell, lease, transfer, lend, assemble, service, or install radiation machines or the supplies used in connection with radiation machines unless the supplies and equipment when properly placed in operation and used, meet the requirements of these rules.

Ariz. Admin. Code § R9-7-206

New Section R9-7-206 recodified from R12-1-206, at 24 A.A.R. 813, effective March 22, 2018 (Supp. 18-1).