410 IAC 5-2-8 - Dealers and assemblers; duties; notice and reports to board

Authority: IC 16-41-35-26; IC 16-41-35-29

Affected: IC 16-41-35

Sec. 8.

(a) Any person who sells, leases, transfers, lends, disposes, assembles, or installs radiation machines in this state shall notify the board within 15 days of:
(1) the name and address of persons who have received these machines;
(2) the manufacturer, model, and serial number of each radiation machine transferred; and
(3) the date of transfer of each radiation machine.
(b) 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 board within 15 days following completion of the assembly. Such report shall suffice in lieu of any other report by the assembler.
(c) No person shall make, sell, lease, transfer, lend, assemble, or install radiation machines 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 410 IAC 5.

Notes

410 IAC 5-2-8
Indiana State Department of Health; Rule HRH-2,PT B,Sec B.8; filed May 26, 1978, 3:30 pm: 1 IR 135; filed Feb 29, 1984, 10:10 am: 7 IR 841; readopted filed Jul 11, 2001, 2:23 p.m.: 24 IR 4234; readopted filed May 22, 2007, 1:44 p.m.: 20070613-IR-410070141RFA; readopted filed Sep 11, 2013, 3:19 p.m.: 20131009-IR-410130346RFA Readopted filed 11/13/2019, 3:14 p.m.: 20191211-IR-410190391RFA

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