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PART IX DEFINITIONS PART IX
DEFINITIONS

As used in these regulations, the following definitions apply:

9.1 "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.

9.2 "Accessible Surface" means the external surface of the enclosure or housing provided by the
manufacturer.

9.3
"Accreditation body" or "body" means an entity that has been approved by FDA to accredit
mammography facilities.

9.4 "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., 1976 SC Code of Law [as amended]).

9.5
"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.

9.6 "Added filtration" means any filtration which is in addition to the inherent filtration.

9.7
"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 30 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

9.8 "Adult" means an individual 18 or more years of age.

9.9
"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 300 kiloelectronvolts 9keV), 1Gy=100rad.

9.10 "ALARA" (acronym for "as low as is reasonably achievable") means making every reasonable
effort to maintain exposures to radiation as far below the dose limits in the Rules in this Chapter 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.

9.11 "Aluminum equivalent" means the thickness of type 1100 aluminum alloy affording the same
attenuation, under specified conditions, as the material in question.

9.12 "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.

9.13 "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.

9.14 "Annually" means at intervals not to exceed 12 consecutive months.

9.15 "Applicator" means a structure which determines the extent of the treatment field at a given
distance from the virtual source.

9.16 "Assembler" means any person engaged in the business of assembling, reassembling, replacing,
installing, or reinstalling one or more components into an x-ray system or subsystem. The term includes
the owner of an x-ray system, his employee, or agent who assembles components into an x-ray system
that is subsequently used to provide professional or commercial services.

9.17 "Attenuation block" means a block or stack, having dimensions 20 centimeters by 20 centimeters by
3.8 centimeters, of type 1100 aluminum alloy or other materials having equivalent attenuation.

9.18 "Authorized representative" means an employee of the Department, or an individual outside the
Department when the individual is specifically so designated by the Department.

9.19 "Automatic exposure control" means a device which automatically controls one or more technique
factors in order to obtain at a preselected location(s) a required quantity of radiation (See also
"Phototimer").

9.20 "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.

9.21 "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 agency.

9.22 "Barrier" (See "Protective Barrier").

9.23 "Beam Axis" means a line from the source through the centers of the x-ray fields.

9.24 "Beam-limiting device" means a device which provides a means to restrict the dimensions of the x-
ray field.

9.25 "Beam monitoring system" means a system designed to detect and measure the radiation present in
the useful beam.

9.26 "Beam scattering foil" means a foil used in order to scatter a beam of electrons.

9.27
"Breast implant" means a prosthetic device implanted in the breast.

9.28 "Cabinet x-ray system" means an x-ray system with the x-ray tube installed in an enclosure which 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.

9.29 "Calendar Quarter" means not less than 12 consecutive weeks nor more than 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 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 these regulations, 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.

9.30 "Calibration" means:

a) the response or reading of an instrument relative to a series of known radiation values over the
range of the instrument; or

b) the strength of a source of radiation relative to a standard.

9.31
"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.

9.32 "C-Arm" means an x-ray system in which 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.

9.33 "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.

9.34 "Cephalometric" means a device intended for the radiographic visualization and measurement of
the dimensions of the human head.

9.35 "Certification" means the process of approval of a facility by the Department to provide
mammography services.

9.36 "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.

9.37 "Certified system" means any x-ray system which has one or more certified component(s).

9.38 "Changeable filters" means any filter, exclusive of inherent filtration, which can be removed from
the useful beam through any electronic, mechanical, or physical process.

9.39 "Change of Status" means transfer of ownership, change of address, or disposal