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

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

Section 44:03:01:01 - Definitions

Terms defined by SDCL 34-21-2 have the same meaning when used in this chapter. In addition, the terms used in this chapter mean:

(1) "Air kerma," the kinetic energy released per unit mass of air or the measurement of radiation energy (joules/J) absorbed per kilogram (kg) of air expressed as J/kg or Gray (Gy);

(2) "Aluminum equivalent," the thickness of type 1100 aluminum alloy affording the same attenuation, under specified conditions, as the material in question;

(3) "Assembler," any person engaged in the business of assembling, replacing, or installing one or more components into an X ray system or subsystem. The term includes the owner of an X ray system or the owner's employee or agent who assembles components into an X ray system that is subsequently used to provide professional or commercial services;

(4) "Automatic exposure control," a device that automatically controls one or more technique factors in order to obtain at a preselected location a required quantity of radiation including phototimes and ion chambers;

(5) "C-arm X ray system," X ray system where the image receptor and X ray tube housing assembly are connected by a common mechanical support system in order to maintain a desired spatial relationship and which is designed to allow a change in the projection of the beam through the patient without a change in the position of the patient;

(6) "Certified components," components of X ray systems that are subject to regulations by the Food and Drug Administration under the Safe Medical Devices Act of 1990, Pub. L. No. 101-629;

(7) "Computed tomography" or "CT," the production of a tomogram by the acquisition and computer processing of X ray transmission data;

(8) "Control panel," that part of the X ray control upon which are mounted the switches, knobs, push buttons, and other hardware necessary for manually setting the technique factors;

(9) "Competency," the ability to apply related knowledge and skills required to successfully perform clinical radiologic procedures;

(10) "Cooling curve," the graphical relationship between heat units stored and cooling time;

(11) "CRT," cathode ray tube in which cathode rays are used to produce an image on a fluorescent screen;

(12) "Dead-man switch," a switch so constructed that a circuit closing contact can be maintained only by continuous pressure on the switch by the operator;

(13) "Department," the Department of Health;

(14) "Diagnostic source assembly," the tube housing assembly with a beam-limiting device attached;

(15) "Diagnostic X ray system," an X ray system designed for irradiation of any part of the human or animal body for the purpose of diagnosis or visualization;

(16) "Diagnostic X ray imaging system," an assemblage of components for the generation, emission, and reception of X ray and the transformation, storage, and visual display of the resultant X ray image;

(17) "Digital radiography," an X ray imaging method or radiography that produces a digital rather than analog image, including computed radiography;

(18) "Dose," a quantity of radiation exposure to the whole anatomy or any portion of the human or animal body;

(19) "Dose area product," the sum total of air kerma over the exposed area of the patient's surface;

(20) "Exposure index," the amount of exposure received by an image receptor;

(21) "Exposure survey," an evaluation of the radiation hazards incident to the production, use, release, disposal, or presence of radiation that may include a physical survey of materials and equipment and measurements of levels of radiation or concentration of radioactive material present;

(22) "Fluoroscopy imaging assembly," a subsystem in which X ray photons produce a visible image. The term includes the image intensifier, spot-film spot imaging device, electrical interlocks, if any, or structural material providing linkage between the image receptor and diagnostic source assembly;

(23) "Gonad shield," a protective barrier for the testes or ovaries;

(24) "Gray" or "Gy," the SI unit of absorbed dose. One Gy equals an energy absorption of one joule (J) per kilogram (kg) of matter in the irradiated object;

(25) "Healing arts," those professional disciplines authorized by SDCL chapter 36-2) to use X ray or radioactive material in the diagnosis or treatment of human or animal disease;

(26) "Heat unit," a unit of energy equal to the product of the peak kilovoltage, milliamps, and seconds, i.e. kVp x mA x second;

(27) "Image intensifier," a device, installed in its housing, that instantaneously converts an X ray pattern into a corresponding light image of higher intensity;

(28) "Image receptor," any device, including a fluorescent screen-or, radiographic film, X ray image intensifier tube, solid-state detector, or gaseous detector, that transforms incident X ray photons either into a visible image or into another form that can be made into a visible image by further transformations;

(29) "Inherent filtration," the filtration of the useful beam provided by the permanently installed components of the tube housing assembly;

(30) "kVp," the maximum value in kilovolts of the potential difference of an X ray generator;

(31) "Lead equivalent," the thickness of lead affording the same attenuation as the material in question;

(32) "Leakage radiation," any radiation coming from within the source housing except for the useful beam and radiation produced when the exposure switch or timer is not activated;

(33) "Licensed practitioner of the healing arts," a person authorized in accordance with SDCL chapter 36-2 for the diagnostic or healing treatment of human and animal maladies and licensed in South Dakota for the lawful practice of medicine;

(34) "Light field," that area of the intersection of the light beam from the beam-limiting device and one of the set of planes parallel to and including the plane of the image receptor, whose perimeter is the locus of points at which the illumination is one-fourth of the maximum in the intersection;

(35) "mA," milliampere;

(36) "mAs," milliampere second;

(37) "Patient," an individual or animal subjected to healing arts examination, diagnosis, or treatment;

(38) "Peak tube potential," the maximum value of the potential difference across the X ray tube during an exposure;

(39) "Personnel monitoring," the use of film badges, pocket chambers, or other devices worn or carried on individuals for the monitoring of personnel exposures to radiation;

(40) "Positive beam limitation," the automatic or semi-automatic adjustment of an X ray beam to the size of the selected image receptor, whereby exposures cannot be made without such adjustment;

(41) "Protective- equipment," an apron, glove, or shield made of radiation absorbing materials used to reduce radiation exposure;

(42) "Qualified expert," an individual who possess the knowledge, training, and experience to measure ionizing radiation, to evaluate safety techniques, and to advise regarding radiation protection needs including health physicists;

(43) "Qualified instructor," an individual who is certified or registered by the American Registry of Radiologic Technologists or who possesses the knowledge, training, and experience in the field of radiation to teach fundamentals of radiation safety, equipment operation, film processing, digital radiography, emergency procedures, personnel dosimetry, anatomy and physiology, and radiographic positioning;

(44) "Qualified physicist," an individual who is competent to independently provide clinical professional services in one or more of the subfields of medical physics, including digital medical physics, nuclear medical physics, therapeutic medical physics, or medical health physics;

(45) "Rad," the special unit of absorbed dose. One rad is equal to an absorbed dose of one hundred erg per gram or 0.01 joule per kilogram;

(46) "Radiation hazard," a condition under which a person might receive radiation in excess of the maximum permissible dose;

(47) "Rem," the special unit of any of the quantities expressed as dose equivalent. The dose equivalent in rem is equal to the absorbed dose in rad;

(48) "Scattered radiation," radiation that, during passage through matter, has been deviated in direction;

(49) "Services," may include calibration of radiation-producing machines or instruments, radiation protection surveys, shielding design, radiological health consultations, and personnel dosimetry;

(50) "Shielding," a protective barrier used to reduce radiation exposure to the required degree. For the purpose of this term, a primary protective barrier is the material, excluding filters, placed in the useful beam and a secondary protective barrier is the material that attenuates stray radiation;

(51) "SI," the International System of Units, or the metric system;

(52) "Sievert" or "Sv," the SI unit of measure for equivalent dose (EqD) and effective dose (EfD). One Sv is equal to one joule (J) per kilogram (kg);

(53) "Source-image receptor distance" or "SID," the distance from the source to the center of the input surface of the image receptor;

(54) "Stray radiation," the sum of leakage and scattered radiation;

(55) "Target," the point at which an X ray is produced;

(56) "Technique factors," the following conditions of operation:

(a) For capacitor energy storage equipment, peak tube potential in kV and quantity of charge in mAs;

(b) For field emission equipment rated for pulsed operation, peak tube potential in kV, and number of X ray pulses;

(c) For CT X ray systems designed for pulsed operation, peak tube potential in kV, scan time in seconds, and either tube current in mA, X ray pulse width in seconds, and the number of X ray pulses per scan, or the product of tube current, X ray pulse width, and the number of X ray pulses in mAs;

(d) For CT X ray systems not designed for pulsed operation, peak tube potential in kV, and either tube current in mA and scan time in seconds, or the product of tube current and exposure time in mAs and the scan time if the scan time and exposure time are equivalent; and

(e) For all other equipment, peak tube potential in kV, and either tube current in mA and exposure time in seconds, or the product of tube current and exposure time in mAs;

(57) "Tube," an X ray tube;

(58) "Variable-aperture beam-limiting device," a beam-limiting device that has capacity for stepless adjustment of the X ray field size at a given SID;

(59) "X ray exposure control," a device, switch, button, or other similar by which an operator initiates or terminates, or both, the radiation exposure, including timers and back-up timers;

(60) "X ray equipment," an X ray system, subsystem, or component of the system;

(61) "X ray field," that area of the intersection of the useful beam and any one of the set of planes parallel to and including the plane of the image receptor, whose perimeter is the locus of points at which the exposure rate is one-fourth of the maximum in the intersection;

(62) "X ray system," an assemblage of components for the controlled production of X rays. The term includes minimally an X ray high-voltage generator, an X ray control, a tube housing assembly, a beam-limiting device, and the necessary supporting structures. Any additional component, which functions with the system, is considered an integral part of the system; and

(63) "X ray tube," any electron tube which is designed for the conversion of electrical energy into X ray energy.

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

SL 1975, ch 16; 50 SDR 041, effective 10/11/2023

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

Law Implemented: SDCL 34-21-11, 34-21-18.