44:03:01:08.  Prohibited uses of radiation. A licensee may not expose a person to diagnostic or therapeutic radiation except for healing arts purposes and only if the exposure has been authorized by a licensed practitioner of the healing arts or as permitted by 42 U.S.C. § 263b in effect on October 25, 2004, with reports going to the person's health care provider for follow-up. A licensee may not expose a person to the useful beam for non-healing arts training, instruction, or demonstration. The following X-radiation producing equipment may not be used and the following specified procedures may not be performed:

    (1)  Fluoroscopic devices for fitting shoes;

    (2)  Photofluorographic equipment;

    (3)  Intraoral fluoroscopy for dental examinations;

    (4)  Hand-held radiographic or fluoroscopic imaging devices, except for intra-oral radiographic imaging devices;

    (5)  The use of fluoroscopy for positioning a patient for general radiographic imaging, except for radiation therapy simulators;

    (6)  The use of fluoroscopy and c-arm X ray systems by a person other than a licensed practitioner of the healing arts unless under the supervision of a licensed practitioner of the healing arts;

    (7)  The use of direct exposure X ray film, without intensifying screens, for routine diagnostic procedures other than intraoral dental radiography, therapeutic portal imaging, and industrial radiography;

    (8)  Nonimage intensified fluoroscopic X ray equipment; or

    (9)  The use of X ray equipment for mammography unless specifically designed by the manufacturer for the imaging of the breast.

    Source: SL 1975, ch 16, § 1; 6 SDR 93, effective July 1, 1980; 26 SDR 96, effective January 23, 2000; 35 SDR 47, effective September 8, 2008; 50 SDR 41, effective October 11, 2023.

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

    Law Implemented: SDCL 34-21-4.1, 34-21-23.

          44:03:01:08.01.  Equipment standards.Repealed.

          Source: SL 1975, ch 16, § 1; transferred from § 44:03:01:13, 6 SDR 93, effective July 1, 1980; repealed, 26 SDR 96, effective January 23, 2000.

    44:03:01:08.02.  Equipment standards for medical diagnostic X ray systems. A diagnostic X ray system must meet the specifications in 21 C.F.R. §§ 1020.30 and 1020.31, in effect on April 1, 2022. In addition, a diagnostic X ray must meet the following standards:

    (1)  Any deviation of a measured technique factor from an indicated value of kilovoltage peak (kVp) may not exceed any limit specified for that system by its manufacturer or, in the absence of any manufacturer's specifications, the deviation may not exceed ten percent of the indicated value for kVp;

    (2)  The tube housing assembly supports must be adjusted so that the tube housing assembly remains stable during an exposure unless tube housing movement is a designed function of the X ray system; and

    (3)  All position locking, holding, and centering devices on the machine must function as intended by the manufacturer.

    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, 34-21-15.

    44:03:01:08.03.  Equipment standards for medical fluoroscopic X ray systems. A fluoroscopic X ray system must meet the specifications in 21 C.F.R. §§ 1020.30 and 1020.31, in effect on April 1, 2022. In addition, a fluoroscopic X ray system must meet the following standards:

    (1)  Any exposure to the operator's eyes above the screen and to the operator's waist behind the leaded drapes may not exceed fifty milliroentgens per hour; and

    (2)  A dead-man switch must control the fluoroscopic device. For the purposes of this subdivision, dead-man switch means a switch so constructed that a circuit closing contact can be maintained only by continuous pressure on the switch by the operator.

    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, 34-21-15.

    44:03:01:08.04.  Equipment standards for medical fluoroscopic spot film devices. Repealed.

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

    44:03:01:08.05.  Periodic measurement of medical fluoroscopic spot film devices. Repealed.

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

    44:03:01:08.06.  Equipment standards for dental X ray systems. All dental X ray systems must meet the specifications in 21 C.F.R. §§ 1020.30 and 1020.31, in effect on April 1, 2022. In addition, a dental X ray system must meet the following standards:

    (1)  Any deviation of a measured technique factor from an indicated value for kilovoltage peak (kVp) may not exceed any limit specified for that system by its manufacturer or, in the absence of any manufacturer's specifications, the deviation may not exceed ten percent of the indicated value for kVp;

    (2)  The exposure switch must be located so the operator can stand at least six feet from the useful beam. If sufficient shielding is provided to protect the operator from stray radiation, the exposure switch may be located closer;

    (3)  Any dental X ray equipment must operate with a kilovoltage of sixty kVp or higher;

    (4)  Any dental X ray machine must be maintained within manufacturer's specifications and recommendations;

    (5)  Any hand-held intraoral X ray equipment must be equipped with a backscatter shield of not less than 0.25 millimeter lead equivalent and 15.2 centimeters in diameter, positioned as close as practicable to the distal end of the position indication device; and

    (6)  Any hand-held device must be secured from unauthorized removal or use.

    When operating a hand-held intraoral dental radiographic unit, operators shall wear a 0.25 millimeter lead equivalent apron, unless otherwise authorized by the department or a qualified physicist.

    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, 34-21-15.

    44:03:01:08.07.  Equipment standards for mobile X ray equipment. In addition to § 44:03:01:08.02, mobile X ray equipment must have the exposure switch located so the operator can stand at least six feet from the useful beam. If sufficient shielding is provided to protect the operator from stray radiation, in which case the exposure switch may be located closer.

    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.

    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.