44:03:01:08.08.  Equipment standards for computed tomography systems. A computed tomography (CT) system must meet the specifications in 21 C.F.R. §§ 1020.30 and 1020.33, in effect on April 1, 2022. In addition, a CT system must meet the following standards:

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

    (2)  Leaded windows, mirrors, a closed-circuit television, or an equivalent must be located to permit the operator to continuously observe the patient during irradiation from the control panel; and

    (3)  If the primary viewing system is by electronic means, an alternate viewing system, which may be electronic, must be available for use if the primary viewing system fails.

    Source: 26 SDR 96, effective January 23, 2000; 50 SDR 41, effective October 11, 2023.

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

    Law Implemented: SDCL 34-21-4.1.