OAR 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.