S.D. Admin. R. 44:03:01:08.08

Current through Register Vol. 51, page 67, December 16, 2024

Section 44:03:01:08.08 - Equipment standards for computed tomography systems

The standards for computed tomography systems are:

(1) All computed tomography systems must meet the specifications in 21 C.F.R. § 1020.30, in effect on March 31, 2000, and 21 C.F.R. § 1020.33, in effect on March 4, 2002;

(2) The system must provide for two-way oral communication between the patient and the operator at the control panel;

(3) Leaded windows, mirrors, closed-circuit television, or an equivalent shall be provided to permit continuous observation of the patient during irradiation and shall be so located that the operator can observe the patient from the control panel;

(4) If the primary viewing system is by electronic means, an alternate viewing system, which may be electronic, shall be available for use in the event of failure of the primary viewing system.

S.D. Admin. R. 44:03:01:08.08

26 SDR 96, effective 1/23/2000; 50 SDR 041, effective 10/11/2023

General Authority: SDCL 34-21-4.1, 34-21-15.

Law Implemented: SDCL 34-21-4.1, 34-21-15.