Or. Admin. R. 333-106-0355 - CT Equipment Requirements

Current through Register Vol. 61, No. 4, April 1, 2022

(1) CT equipment requirements shall comply with the Food and Drug Administration's 21 CFR in the following areas:
(a) Information to be provided for users - Part 1020.33(c);
(b) Quality Assurance - Part 1020.33(d);
(c) Control and indication of conditions of operation - Part 1020.33(f);
(d) Tomographic plane indication and alignment - Part 1020.33(g);
(e) Beam-on and status indicators - Part 1020.33(h);
(f) Scan increment accuracy - Part 1020.33(i); and
(g) CT number mean and standard deviation - Part 1020.33(j).
(2) CT equipment shall be maintained in compliance with the requirements of section (1) of this rule.

Notes

Or. Admin. R. 333-106-0355
HD 1-1991, f. & cert. ef. 1-8-91; PH 12-2006, f. & cert. ef. 6-16-06; PH 14-2008, f. & cert. ef. 9-15-08; PH 24-2014, f. & cert. ef. 8-15-14

Stat. Auth.: ORS 453.605 - 453.807

Stats. Implemented: ORS 453.605 - 453.807

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