Or. Admin. R. 333-101-0060 - Assembler and/or Transfer Obligation

(1) Any person who sells, leases, transfers, lends, disposes, assembles or installs radiation machines in this state must notify the Authority within 15 days of:
(a) The name and address of persons who have received these machines;
(b) The manufacturer, model and serial number of each radiation machine transferred; and
(c) The date of the transfer of each radiation machine.
(2) 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 must meet the requirements of these rules.
(3) 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)) must be submitted to the Authority within 15 days following completion of the assembly. Such report must suffice in lieu of any other report by the assembler.


Or. Admin. R. 333-101-0060
HD 1-1991, f. & cert. ef. 1-8-91; PH 12-2006, f. & cert. ef. 6-16-06

Publications: Publications referenced are available from the agency.

Stat. Auth.: ORS 453.605 - ORS 453.807

Stats. Implemented: ORS 453.605 - ORS 453.807

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