Oregon
Rule Rule 333-106-0355
CT Equipment Requirements


(1)

CT equipment requirements shall comply with the Food and Drug Administrations 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.
Source
Last accessed
Mar. 28, 2020