1. (1) CT equipment requirements shall comply with the Food and Drug Administration’s 21 CFR in the following areas:

   1. (a) Information to be provided for users — Part 1020.33(c);
   2. (b) Quality Assurance — Part 1020.33(d);
   3. (c) Control and indication of conditions of operation — Part 1020.33(f);
   4. (d) Tomographic plane indication and alignment — Part 1020.33(g);
   5. (e) Beam-on and status indicators — Part 1020.33(h);
   6. (f) Scan increment accuracy — Part 1020.33(i); and
   7. (g) CT number mean and standard deviation — Part 1020.33(j).
2. (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