South Carolina Code of Regulations › Chapter 61 - DEPARTMENT OF HEALTH AND ENVIRONMENTAL CONTROL › Subchapter 61-64 - X-Rays (Title B) › Part X - DEFINITIONS

Current through Register Vol. 48, No. 6, June 28, 2024
As used in this regulation, the following definitions
				apply:
10.1 "Absorbed dose" is the
			 energy imparted to matter by ionizing radiation per unit mass of irradiated
			 material at the place of interest. The special units of absorbed dose are the
			 rad or the gray.
10.2 "Accessible
			 surface" means the external surface of the enclosure or housing provided by the
			 manufacturer.
10.3 "Accreditation
			 body" or "body" means an entity that has been approved by the FDA to accredit
			 mammography facilities.
10.4 "Act"
			 means Act No. 223, Atomic Energy and Radiation Control Act enacted by the 1967
			 Session South Carolina Legislature. [Section
			 13-7-40
et seq
.,
			 S.C. Code of Laws (1976, as amended)].
10.5 "Action limits" or "action levels" means
			 the minimum and maximum values of a quality assurance measurement that can be
			 interpreted as representing acceptable performance with respect to the
			 parameter being tested. Values less than the minimum or greater than the
			 maximum action limit or level indicate that corrective action shall be taken by
			 the facility. Action limits or levels are also sometimes called control limits
			 or levels.
10.6 "Adverse event"
			 means an undesirable experience associated with mammography activities that
			 include, but are not limited to: poor image quality; failure to send
			 mammography reports within thirty (30) calendar days to the referring physician
			 or in a timely manner to the self-referred patient; and use of personnel that
			 do not meet the requirements.
10.7
			 "Adult" means an individual eighteen (18) years of age or older.
10.8 "Air kerma" means kerma in a given mass
			 of air. The unit used to measure the quantity of air kerma is the Gray (Gy).
			 For x-rays with energies less than three hundred kiloelectronvolts (300 keV), 1
			 Gy=100 rad. In air, 1 Gy of absorbed dose is delivered by one hundred fourteen
			 roentgens (114 R) of exposure.
10.9
			 "ALARA" (acronym for "as low as is reasonably achievable") means making every
			 reasonable effort to maintain exposures to ionizing radiation as far below the
			 dose limits in this regulation as is practical, consistent with the purpose for
			 which the licensed or registered activity is undertaken, taking into account
			 the state of technology, the economics of improvements in relation to state of
			 technology, the economics of improvements in relation to benefits to the public
			 health and safety, and other societal and socioeconomic considerations, and in
			 relation to utilization of sources of radiation in the public
			 interest.
10.10 "Aluminum
			 equivalent" means the thickness of type 1100 aluminum alloy affording the same
			 attenuation, under specified conditions, as the material in question.
10.11 "Analytical x-ray equipment" means any
			 machine utilizing x-rays for examination of the microscopic structure, or
			 elemental or chemical composition of materials. This includes x-ray equipment
			 used for x-ray diffraction, fluorescence analysis, or spectroscopy.
10.12 "Analytical x-ray system" means a group
			 of local and remote components utilizing x-rays to determine the elemental
			 composition or to examine the microstructure of materials. Local components
			 include those that are struck by x-rays such as radiation source housings, port
			 and shutter assemblies, collimators, sample holders, cameras, goniometers,
			 detectors, and shielding. Remote components include power supplies,
			 transformers, amplifiers, readout devices, and control panels.
10.13 "Annually" means at intervals not to
			 exceed twelve (12) consecutive months.
10.14 "Applicator" means a structure which
			 determines the extent of the treatment field at a given distance from the
			 virtual source.
10.15 "Attenuation
			 block" means a block or stack of type 1100 aluminum alloy, or aluminum alloy
			 having equivalent attenuation, with dimensions twenty (20) centimeters (cm) or
			 larger by twenty (20) cm or larger by 3.8 cm, that is large enough to intercept
			 the entire x-ray beam.
10.16
			 "Authorized representative" means an employee of the Department, or an
			 individual outside the Department when the individual is specifically so
			 designated by the Department.
10.17
			 "Automatic exposure control" means a device which automatically controls one
			 (1) or more technique factors in order to obtain at a preselected location(s) a
			 required quantity of radiation (See also "Phototimer").
10.18 "Average glandular dose" means, in
			 mammography, the value in millirad for a given breast or phantom thickness
			 which estimates the average absorbed dose to the glandular tissue extrapolated
			 from free air exposures and based on fixed filter thickness and target
			 material.
10.19 "Background
			 radiation" means radiation from cosmic sources, naturally occurring radioactive
			 materials, including radon (except as a decay product of source or special
			 nuclear material) and global fallout as it exists in the environment from the
			 testing of nuclear explosive devices. "Background radiation" does not include
			 sources of radiation regulated by the Department.
10.20 "Barrier" (See "Protective
			 Barrier").
10.21 "Beam axis" means
			 a line from the source through the centers of the x-ray fields.
10.22 "Beam-limiting device" means a device
			 which provides a means to restrict the dimensions of the x-ray field.
10.23 "Beam monitoring system" means a system
			 designed to detect and measure the radiation present in the useful
			 beam.
10.24 "Beam scattering foil"
			 means a thin piece of material (usually metallic) placed in the beam to scatter
			 a beam of electrons in order to provide a more uniform electron distribution in
			 the useful beam.
10.25 "Bone
			 densitometer" means a device intended for medical purposes to measure bone
			 density and mineral content by x-ray or gamma ray transmission measurements
			 through the bone and adjacent tissues.
10.26 "Breast implant" means a prosthetic
			 device implanted in the breast.
10.27 "Cabinet radiography" means industrial
			 radiography conducted in an enclosure or cabinet so shielded that every
			 location on the exterior meets the dose limits as specified in Part III of this
			 regulation.
10.28 "Cabinet x-ray
			 system" means an x-ray system with the x-ray tube installed in an enclosure
			 which, independently of existing architectural structures except the floor on
			 which it may be placed, is intended to contain at least that portion of a
			 material being irradiated, provide radiation attenuation, and exclude personnel
			 from its interior during x-ray production. An x-ray tube used within a shielded
			 part of a building, or x-ray equipment which may temporarily or occasionally
			 incorporate portable shielding, is not considered a cabinet x-ray
			 system.
10.29 "Calendar quarter"
			 means not less than twelve (12) consecutive weeks nor more than fourteen (14)
			 consecutive weeks. The first calendar quarter of each year shall begin in
			 January; and subsequent calendar quarters shall be such that no day is included
			 in more than one (1) calendar quarter or omitted from inclusion within a
			 calendar quarter. No registrant shall change the method observed by him of
			 determining calendar quarters for purposes of this regulation, except at the
			 beginning of a calendar year. For the purpose of Part V, "Calendar quarter"
			 means any one of the following time periods during a given year: January 1
			 through March 31, April 1 through June 30, July 1 through September 30, or
			 October 1 through December 31.
10.30 "Category I" means medical educational
			 activities that have been designated as Category I by the Accreditation Council
			 for Continuing Medical Education (ACCME), the American Osteopathic Association
			 (AOA), a state medical society or an equivalent organization.
10.31 "C-arm" means a fluoroscopic x-ray
			 system in which the image receptor and x-ray tube housing assembly are
			 connected or coordinated to maintain a spatial relationship. Such a system
			 allows a change in the direction of the beam axis with respect to the patient
			 without moving the patient.
10.32
			 "Central axis of the beam" means a line passing through the virtual source and
			 the center of the plane figure formed by the edge of the first beam-limiting
			 device.
10.33 "Cephalometric" means
			 a device intended for the radiographic visualization and measurement of the
			 dimensions of the human head.
10.34
			 "Certification" for Part V, means the process of approval of a facility by the
			 Department to provide mammography services.
10.35 "Certified components" means components
			 of x-ray systems which are subject to the Regulations for the Administration
			 and Enforcement of the Radiation Control for Health and Safety Act of 1968,
			 promulgated under Public
			 Law 90-602.
10.36 "Certified system" means any x-ray
			 system which has one (1) or more certified component(s).
10.37 "Change of status" means transfer of
			 ownership, change of address, or disposal of any x-ray system.
10.38 "Clinical image" means a
			 mammogram.
10.39 "Coefficient of
			 variation" or "C" means the ratio of the standard deviation to the mean value
			 of a population of observations. It is estimated using the following equation:
Click to view
				image
where:
s = Estimated standard deviation of the population.
X= Mean value of observations in sample.
Xi =
i
th observation in
				sample.
n = Number of observations in sample.
10.40 "Collimator" means a device or
			 mechanism by which the x-ray beam is restricted in size.
10.41 "Committed dose equivalent" means the
			 dose equivalent to organs or tissues of reference (T) that will be received
			 from an intake of radioactive material by an individual during the fifty
			 (50)-year period following the intake.
10.42 "Consumer" means an individual who
			 chooses to comment or complain in reference to a mammography examination,
			 including the patient or representative of the patient (e.g., family member or
			 referring physician).
10.43
			 "Contact hour" means an hour of training received through direct
			 instruction.
10.44 "Continuing
			 education unit or continuing education credit" means one (1) contact hour of
			 training.
10.45 "Controlled area"
			 means an area outside of a restricted area but inside the site boundary, access
			 to which can be limited by the registrant for any reason.
10.46 "CT" (See "Computed
			 Tomography").
10.47 "Computed
			 tomography (CT)" means the production of a tomogram by the acquisition and
			 computer processing of x-ray transmission data.
10.48 "Contact therapy system" means an x-ray
			 system used for therapy with the x-ray tube port placed in contact with or
			 within five centimeters (5 cm) of the surface being treated.
10.49 "Control panel" means that part of the
			 x-ray control upon which are mounted the switches, knobs, pushbuttons, keypads,
			 touchscreens, and other hardware necessary for manually setting the technique
			 factors.
10.50 "Cooling curve"
			 means the graphical relationship between heat units stored and cooling
			 time.
10.51 "CT conditions of
			 operation" means all selectable parameters governing the operation of a CT
			 x-ray system including, but not limited to, nominal tomographic section
			 thickness, filtration, and the technique factors.
10.52 "CT Gantry" means the tube housing
			 assemblies, beam-limiting devices, detectors, and the supporting structures,
			 frames, and covers which hold and/or enclose these components within a computed
			 tomography system.
10.53 "Coulomb
			 per Kilogram" (C/kg) is the unit of exposure. One (1) Roentgen is equal to 2.58
			 × 10-4 Coulomb per kilogram. Submultiples of
			 this unit are the milliCoulomb per kilogram (mC/kg) and the microCoulomb per
			 kilogram (uC/kg).
10.54 "Dead man's
			 switch" means a switch so constructed that a circuit closing contact can be
			 maintained only by continuous pressure on the switch by the operator.
10.55 "Declared pregnant woman" means a woman
			 who has voluntarily informed her employer, in writing, of her pregnancy and the
			 estimated date of conception.
10.56
			 "Deep-dose equivalent (Hd)," which applies to external
			 whole-body exposure, is the equivalent at a tissue depth of one centimeter (1
			 cm) (1000 mg/cm2).
10.57 "Department" means the South Carolina
			 Department of Health and Environmental Control.
10.58 "Detector" (See "Radiation
			 detector").
10.59 "Diagnostic
			 mammography" means mammography performed on a patient with:
(a) Clinical signs, symptoms, or physical
			 findings suggestive of breast cancer;
(b) An abnormal or questionable screening
			 mammogram;
(c) A history of breast
			 cancer with breast conservation surgery regardless of absence of clinical
			 breast signs, symptoms, or physical findings; or
(d) Augmented breast regardless of absence of
			 clinical breast signs, symptoms, or physical findings.