16 Del. Admin. Code § 4465-B-15.0

Current through Register Vol. 28, No. 7, January 1, 2025

Section 4465-B-15.0 - Assembler and/or Transfer Obligation

15.1 Any person who sells, leases, transfers, lends, disposes, assembles, or installs radiation sources in this State shall notify the Agency within 15 days of:

15.1.1 The name and address of persons who have received these sources;

15.1.2 The manufacturer, model, and serial number of each radiation source transferred; and

15.1.3 The date of transfer of each radiation source.

15.1.4 In the case of diagnostic x-ray systems which contain certified components, a copy of the assembler's report prepared in compliance with requirements of the Federal diagnostic x-ray standard ( 21 CFR 1020.30(d) ) shall be submitted to the Agency following completion of the assembly. Such report shall suffice in lieu of any other report by the assembler.

15.2 No person shall make, sell, lease, transfer, lend, assemble, or install radiation sources or the supplies used in connection with such machines unless such supplies and equipment when properly placed in operation and used shall meet the requirements of these regulations.

16 Del. Admin. Code § 4465-B-15.0

17 DE Reg. 983 (4/1/2014) (Final)