44:03:01:11. Installation of radiation facilities or equipment.Repealed.
Source: SL 1975, ch 16, § 1; repealed, 6 SDR 93, effective July 1, 1980.
44:03:01:11.01. Shielding plan review prior to installation of radiation facilities or equipment. Prior to construction, the facility owner or the facility's shielding plan designer must submit the floor plans, shielding specifications, and equipment arrangement of any new X-radiation producing equipment installation or any modification of existing X-radiation producing equipment installations to the department for review and approval. The plans must show:
(1) The normal location of the machine's radiation port, the general direction of the useful beam, the location of any windows and doors or other openings, the location of the operator's booth, and the location of the control panel;
(2) The structural composition and thickness or lead equivalent of all walls, doors, partitions, floor, and ceiling of the room concerned;
(3) The dimensions of any room concerned;
(4) The type of occupancy of any adjacent areas inclusive of space above and below the room concerned. If there is an exterior wall, the plans must show distance to the closest area where it is likely that individuals may be present;
(5) The make and model of the equipment, the maximum technique factors, and the energy waveform; and
(6) The type of examinations or treatments to be performed with the equipment and the anticipated workload of the system in milliampere-minutes per week.
The department may require the applicant to utilize the services of a qualified physicist to determine the shielding requirements prior to the plan review and approval. The approval of the plans by the department does not preclude the requirement for additional modifications should a subsequent change of operating conditions create the possibility of an individual receiving a dose in excess of the limits.
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, 34-21-17.
44:03:01:11.02. Installation requirements of all radiation equipment. No person may make, sell, lease, transfer, lend, assemble, or install any radiation machine or any supplies used in connection with such a machine unless such supplies and equipment meet the requirements of this chapter when placed in operation.
Source: 26 SDR 96, effective January 23, 2000.
General Authority: SDCL 34-21-15.
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.
Source: 26 SDR 96, effective January 23, 2000; 50 SDR 41, effective October 11, 2023.
General Authority: SDCL 34-21-15.
Law Implemented: SDCL 34-21-4.1, 34-21-17.
44:03:01:11.04. Licensee requirements after installation of radiation equipment. After completion of construction and installation of radiation equipment, the licensee shall maintain for inspection:
(1) Model and serial number of all major components and user's manuals for those components;
(2) Records of surveys, calibrations, maintenance, and modifications performed on the X ray systems;
(3) The maximum rated technique factors of each machine with tube rating and cooling curves charts; and
(4) Scale drawing of the room in which a stationary radiation machine system is located with such drawing indicating the use of areas adjacent to the room and an estimation of the extent of occupancy by an individual in such areas; the results of a survey for radiation levels present at the operator's position and at pertinent points outside the room; and the type and thickness of materials, or lead equivalency, in each protective barrier used in the room.
For the purpose of this section, cooling curve is the geographical relationship between heat units stored and cooling time.
Source: 26 SDR 96, effective January 23, 2000; 50 SDR 41, effective October 11, 2023.
General Authority: SDCL 34-1-17, 34-21-15.
Law Implemented: SDCL 34-21-4.1, 34-21-17.
