S.D. Admin. R. 44:03:01:11.03

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

Section 44:03:01:11.03 - Notification of installation of radiation equipment

Any assembler who installs radiation machines in this state shall report to the department within fifteen days the following information:

(1) The name and address of the persons who have received these machines;

(2) The manufacturer, model, and serial number of each radiation machine and major components transferred;

(3) The date of transfer of each radiation machine; and

(4) The date of installation of each radiation machine.

In the case of diagnostic X ray systems which contain certified components, the licensee must submit a copy of the assembler's report, Form FDA 2579 (6/95), prepared in compliance with requirements of the Federal Diagnostic X Ray Standard, 21 C.F.R. 1030.30(d), as of April 1, 2022, to the department within fifteen days following completion of the assembly.

For the purposes of this section, assembler means any person, including the owner of the X ray system or the owner's employee or agency, engaged in the business of assembling, replacing, or installing one or more components into an X ray system or subsystem that is subsequently used to provide professional or commercial services.

S.D. Admin. R. 44:03:01:11.03

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

General Authority: SDCL 34-21-15.

Law Implemented: SDCL 34-21-4.1, 34-21-17.