Oregon Health Authority
Public Health Division - Chapter 333
Division 106
X-RAYS IN THE HEALING ARTS
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.
Statutory/Other Authority: ORS 453.605 - 453.807
Statutes/Other Implemented: ORS 453.605 - 453.807
History:
PH 24-2014, f. & cert. ef. 8-15-14
PH 14-2008, f. & cert. ef. 9-15-08
PH 12-2006, f. & cert. ef. 6-16-06
HD 1-1991, f. & cert. ef. 1-8-91