Or. Admin. Code § 333-106-0355

Current through Register Vol. 64, No. 1, January 1, 2025

Section 333-106-0355 - CT Equipment Requirements

(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.

Or. Admin. Code § 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