Hawaii Administrative Rules › Title 11 - DEPARTMENT OF HEALTH › Subtitle 1 - GENERAL DEPARTMENTAL PROVISIONS › Chapter 45 - RADIATION CONTROL › Subchapter 1 - GENERAL PROVISIONS › Section 11-45-2 - Definitions

Current through June, 2024
As used in this chapter:
"Absorbed dose" means the energy imparted by ionizing
					 radiation per unit mass of irradiated material. The units of absorbed dose are
					 the gray (Gy) and the rad.
"Accelerator-produced material" means any material made
					 radioactive by a particle accelerator.
"Accessible surface" means the external surface of the
					 enclosure or housing of an x-ray system component provided by the
					 manufacturer.
"Activity" means the rate of disintegration or
					 transformation or decay of radioactive material. The units of activity are the
					 becquerel (Bq) and the curie (Ci).
"Added filtration" means any filtration which is in
					 addition to the inherent filtration.
"Address of use" means the building or buildings that are
					 identified on the license and where radioactive material may be produced,
					 prepared, received, used, or stored.
"Adult" means an individual eighteen or more years of
					 age.
"Air kerma" (K) means the kinetic energy released in air
					 by ionizing radiation. Kerma is determined as the quotient of dE by dM, where
					 dE is the sum of the initial kinetic energies of all the charged ionizing
					 particles liberated by uncharged ionizing particles in air of mass dM. The SI
					 unit of air kerma is joule per kilogram and the special name for the unit of
					 kerma is the gray (Gy).
"Airborne radioactive material" means any radioactive
					 material dispersed in the air in the form of dusts, fumes, particulates, mists,
					 vapors, or gases.
"Airborne radioactivity area" means a room, enclosure, or
					 area in which airborne radioactive materials exist in concentrations:
(1) In excess of the derived air concentrations (DACs)
					 specified in Appendix B, Table I, of subchapter 4, or
(2) To such a degree that an individual present in the area
					 without respiratory protective equipment could exceed, during the hours an
					 individual is present in a week, an intake of 0.6 percent of the annual limit
					 on intake (ALI) or twelve DAC-hours.
"Aluminum equivalent" means the thickness of type 1100
					 aluminum alloy affording the same attenuation, under specified conditions, as
					 the material in question.
"Analytical x-ray equipment" means equipment used for
					 x-ray diffraction or fluorescence analysis.
"Analytical x-ray system" means a group of components
					 utilizing x or gamma rays to determine the elemental composition or to examine
					 the microstructure of materials.
"Annual limit on intake" (ALI) means the derived limit for
					 the amount of radioactive material taken into the body of an adult worker by
					 inhalation or ingestion in a year. ALI is the smaller value of intake of a
					 given radionuclide in a year by the reference man that would result in a
					 committed effective dose equivalent of five rems (0.05 sievert) or a committed
					 dose equivalent of fifty rems (0.5 sievert) to any individual organ or tissue.
					 ALI values for intake by ingestion and by inhalation of selected radionuclides
					 are given in Table I, Columns 1 and 2, of Appendix B of subchapter 4.
"Applicator" means a structure which determines the extent
					 of the treatment field at a given distance from the virtual source.
"Area of use" means a portion of a physical structure that
					 has been set aside for the purpose of producing, preparing, receiving, using,
					 or storing radioactive material.
"As low as is reasonably achievable" (ALARA) means making
					 every reasonable effort to maintain exposures to radiation as far below the
					 dose limits in these rules as is practical, consistent with the purpose for
					 which the licensed 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 nuclear energy and licensed sources of radiation in the public
					 interest.
"Assembler" means 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 his or
					 her employee or agent who assembles components into an x-ray system that is
					 subsequently used to provide professional or commercial services.
"Attenuation block" means a block or stack of type 1100
					 aluminum alloy or aluminum alloy having equivalent attenuation with dimensions
					 twenty centimeters by twenty centimeters by 3.8 centimeters, of type 1100
					 aluminum alloy or other materials having equivalent attenuation.
"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. (Includes devices
					 such as phototimers and ion chambers.)
"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 including global
					 fallout as it exists in the environment from the testing of nuclear explosive
					 devices. "Background radiation" does not include sources of radiation from
					 radioactive materials regulated by the department.
"Beam axis" means a line from the source through the
					 centers of the x-ray fields.
"Beam-limiting device" means a device which provides a
					 means to restrict the dimensions of the x-ray field.
"Beam scattering filter" means a filter used in order to
					 scatter a beam of electrons.
"Becquerel" (Bq) means the SI unit of activity. One
					 becquerel is equal to one disintegration or transformation per second
					 (s-1).
"Bioassay" means the determination of kinds, quantities or
					 concentrations, and, in some cases, the locations of radioactive material in
					 the human body, whether by direct measurement, in vivo counting, or by analysis
					 and evaluation of materials excreted or removed from the human body. For
					 purposes of these rules, "radiobioassay" is an equivalent term.
"Byproduct material" means:
(1) Any radioactive material, except special nuclear
					 material, yielded in or made radioactive by exposure to the radiation incident
					 to the process of producing or utilizing special nuclear material; and
(2) The tailings or wastes produced by the extraction or
					 concentration of uranium or thorium from ore processed primarily for its source
					 material content, including discrete surface wastes resulting from uranium or
					 thorium solution extraction processes. Underground ore bodies depleted by these
					 solution extraction operations do not constitute "byproduct material" within
					 this definition.
"C-Arm x-ray system" 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.
					 This system is designed to allow a change in the projection of the beam through
					 the patient without a change in the position of the patient.
"Cabinet radiography" means industrial radiography
					 conducted in an enclosure or cabinet shielded so that radiation levels at every
					 location on the exterior meet the limitations specified in subchapter 4 of
					 these rules.
"Cabinet x-ray system" means an x-ray system with the
					 x-ray tube installed in an enclosure independent of existing architectural
					 structures except the floor on which it may be placed. The cabinet x-ray system
					 is intended to contain at least that portion of a material being irradiated,
					 provide radiation attenuation, and exclude personnel from its interior during
					 generation of radiation. Included are all x-ray systems designed primarily for
					 the inspection of carry-on baggage at airline, railroad, and bus terminals, and
					 in similar facilities. 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.
"Calendar quarter" means not less than twelve consecutive
					 weeks nor more than fourteen consecutive weeks. The first calendar quarter of
					 each year shall begin in January and subsequent calendar quarters shall be so
					 arranged such that no day is included in more than one calendar quarter and no
					 day in any one year is omitted from inclusion within a calendar quarter. No
					 licensee shall change the method observed by him of determining calendar
					 quarters for purposes of this chapter except at the beginning of a calendar
					 year.
"Calibration" means the determination of:
(1) The response or reading of an instrument relative to a
					 series of known radiation values over the range of the instrument; or
(2) The strength of a source of radiation relative to a
					 standard.
"Carrier" means a person engaged in the transportation of
					 passengers or property by land or water as a common, contract, or private
					 carrier, or by civil aircraft.
"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.
"Cephalometric device" means a device intended for the
					 radiographic visualization and measurement of the dimensions of the human
					 head.
"Certified cabinet x-ray system" means an x-ray system
					 which has been certified in accordance with
					 21
					 C.F.R. 1010.2 as being manufactured and
					 assembled pursuant to the provisions of 21 C.F.R. 71020.40.
"Certified components" means components of x-ray systems
					 which are subject to regulations promulgated under Public Law 90-602, Radiation
					 Control for Health and Safety Act of 1968.
"Certified system" means any x-ray system which has one or
					 more certified component(s).
"C.F.R." means Code of Federal Regulations.
"Changeable filters" means any filter, exclusive of
					 inherent filtration, which can be removed from the useful beam through any
					 electronic, mechanical, or physical process.
"Chelating agent" means amine polycarboxylic acids,
					 hydroxycarboxylic acids, gluconic acid, and polycarboxylic acids.
"Class" means a classification scheme for inhaled material
					 according to its rate of clearance from the pulmonary region of the lung.
					 Materials are classified as D, W, or Y, which applies to a range of clearance
					 half-times: for Class D, Days, of less than ten days, for Class W, Weeks, from
					 ten to one hundred days, and for Class Y, Years, of greater than one hundred
					 days. For purposes of these rules, "lung class" and "inhalation class" are
					 equivalent terms.
"Coefficient of variation" means the ratio of the standard
					 deviation to the mean value of a population of observations.
"Collective dose" means the sum of the individual doses
					 received in a given period of time by a specified population from exposure to a
					 specified source of radiation.
"Collimator" means a device used to limit the size, shape,
					 and direction of the primary radiation beam.
"Committed dose equivalent" (HT,50)
					 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-year period following the intake.
"Committed effective dose equivalent" (HE,
					 50) is the sum of the products of the weighting factors applicable
					 to each of the body organs or tissues that are irradiated and the committed
					 dose equivalent to each of these organs or tissues (HE,
					 50 = [SUMATION] wT
					 HT,50).
"Computed tomography" (CT) means the production of a
					 tomogram by the acquisition and computer processing of x-ray transmission
					 data.
"Contrast scale" means the change in the linear
					 attenuation coefficient per CTN relative to water, that is:
Click Here To View
					 Image
where:
µx = Linear attenuation
					 coefficient of the material of interest.
µw = Linear attenuation
					 coefficient of water.
(CTN)X = CTN of the material of
					 interest.
(CTN)w = CTN of water.
"Control panel" means that part of the x-ray control upon
					 which are mounted the switches, knobs, push buttons, and other hardware
					 necessary for setting the technique factors.
"Controlled area" means an area, outside of a restricted
					 area but inside the site boundary, access to which can be limited by the
					 licensee for any reason.
"Cooling curve" means the graphical relationship between
					 heat units stored and cooling time.
"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.
"CT gantry" means the tube housing assemblies,
					 beam-limiting devices, detectors, and the supporting structures and frames
					 which hold these components.
"Curie" (Ci) means a unit of quantity of radioactivity.
					 One curie is that quantity of radioactive material which decays at the rate of
					 3.7 x 1010 transformations per second (tps).
"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.
"Declared pregnant woman" means a woman who has
					 voluntarily informed her employer, in writing, of her pregnancy.
"Deep dose equivalent" (Hd) , which
					 applies to external whole body exposure, means the dose equivalent at a tissue
					 depth of one centimeter (one-thousand milligrams per square centimeter).
"Department" means the department of health.
"Derived air concentration" (DAC) means the concentration
					 of a given radionuclide in air which, if breathed by the reference man for a
					 working year of two thousand hours under conditions of light work, results in
					 an intake of one ALI. For purposes of these rules, the condition of light work
					 is an inhalation rate of 1.2 cubic meters of air per hour for two thousand
					 hours in a year. DAC values are given in Table I, Column 3, of Appendix B of
					 subchapter 4.
"Derived air concentration-hour" (DAC-hour) means the
					 product of the concentration of radioactive material in air, expressed as a
					 fraction or multiple of the derived air concentration for each radionuclide,
					 and the time of exposure to that radionuclide, in hours. A licensee may take
					 two thousand DAC-hours to represent one ALI, equivalent to a committed
					 effective dose equivalent of five rems (0.05 sievert).
"Detector" (See "Radiation detector").
"Diagnostic clinical procedures manual" means a collection
					 of written procedures that describes each method (and other instructions and
					 precautions) by which the licensee performs diagnostic clinical procedures;
					 where each diagnostic clinical procedure has been approved by the authorized
					 user and includes the pharmaceutical, dosage, and route of
					 administration.
"Diagnostic source assembly" means the tube housing
					 assembly with a beam-limiting device attached.
"Diagnostic x-ray imaging system" means an assemblage of
					 components for the generation, emission and reception of x-rays and the
					 transformation, storage and visual display of the resultant x-ray image.
"Diagnostic x-ray system" means an x-ray system designed
					 for irradiation of any part of the human or animal body for the purpose of
					 diagnosis or visualization.
"Direct scattered radiation" means that scattered
					 radiation which has been deviated in direction only by materials irradiated by
					 the useful beam (See "Scattered radiation").
"Director" means the director of the department of health,
					 State of Hawaii, or a duly authorized agent.
"Dose" is a generic term that means absorbed dose, dose
					 equivalent, effective dose equivalent, committed dose equivalent, committed
					 effective dose equivalent, or total effective dose equivalent. For purposes of
					 these rules, "radiation dose" is an equivalent term.
"Dose equivalent" (HT) means the
					 product of the absorbed dose in tissue, quality factor, and all other necessary
					 modifying factors at the location of interest. The units of dose equivalent are
					 the sievert (Sv) and rem.
"Dose limits" means the permissible upper bounds of
					 radiation doses established in accordance with these rules. For purposes of
					 these rules, "limits" is an equivalent term.
"Dose monitoring system" means a system of devices for the
					 detection, measurement, and display of quantities of radiation.
"Dose monitor unit" means a unit response from the dose
					 monitoring system from which the absorbed dose can be calculated.
"Dose profile" means the dose as a function of position
					 along a line.
"Dosimetry processor" means person that processes and
					 evaluates individual monitoring devices in order to determine the radiation
					 dose delivered to the monitoring devices.
"Effective dose equivalent" (HE)
					 means the sum of the products of the dose equivalent to each organ or tissue
					 (HT) and the weighting factor
					 (wT) applicable to each of the body organs or tissues
					 that are irradiated (HE = [SUMATION]
					 wT HT).
"Elemental area" means the smallest area within a tomogram
					 for which the x-ray attenuation properties of a body are depicted. (See also
					 "Picture element").
"Embryo/fetus" means the developing human organism from
					 conception until the time of birth.
"Entrance or access point" means any opening through which
					 an individual or extremity of an individual could gain access to radiation
					 areas or to licensed radioactive materials. This includes entry or exit portals
					 of sufficient size to permit human entry, irrespective of their intended
					 use.
"Entrance exposure rate" means the exposure free in air
					 per unit time at the point where the center of the useful beam enters the
					 patient.
"Existing equipment" means therapy systems subject to
					 subchapter 14 which were manufactured on or before January 1, 1985.
"Explosive material" means any chemical compound, mixture,
					 or device which produces a substantial instantaneous release of gas and heat
					 spontaneously or by contact with sparks or flame.
"Exposure" means, when used as a verb, being exposed to
					 ionizing radiation or to radioactive material. When used as a noun, "exposure"
					 means the quotient of dQ by dm where "dQ" is the absolute value of the total
					 charge of the ions of one sign produced in air when all the electrons
					 (negatrons and positrons) liberated by photons in a volume element of air
					 having mass "dm" are completely stopped in air. The special unit of exposure is
					 the roentgen (R). One roentgen is equal to 2.58 x
					 10-4 coulombs per kilogram of air.
"Exposure rate" means the exposure per unit of time, such
					 as roentgen per minute and milliroentgen per hour.
"External dose" means that portion of the dose equivalent
					 received from any source of radiation outside the body.
"Extremity" means hand, elbow, arm below the elbow, foot,
					 knee, and leg below the knee.
"Eye dose equivalent" means the external dose equivalent
					 to the lens of the eye at a tissue depth of 0.3 centimeter (three hundred
					 milligrams per centimeter squared).
"Facility" means the location at which one or more devices
					 or sources are installed and/or located within a building, office, vehicle, or
					 under one roof.
"Fail-safe characteristics" mean a design feature which
					 causes beam port shutters to close, or otherwise prevents emergence of the
					 primary beam, upon the failure of a safety or warning device.
"Field emission equipment" means equipment which uses an
					 x-ray tube in which electron emission from the cathode is due solely to the
					 action of an electric field.
"Field-flattening filter" means a filter used to provide
					 dose uniformity over the area of a useful beam of x-rays at a specified
					 depth.
"Field size" means the dimensions along the major axes of
					 an area in a plane perpendicular to the specified direction of the beam of
					 incident radiation at the normal treatment distance and defined by the
					 intersection of the major axes and the fifty percent isodose line. Material
					 shall be placed in the beam such that dose maximum is produced at the normal
					 treatment distance when field size is being determined.
"Filter" means material placed in the useful beam to
					 absorb preferentially selected radiations.
"Fissile material" means any special nuclear material
					 consisting of or containing one or more fissile radionuclides. Fissile
					 radionuclides are plutonium-238, plutonium-239, plutonium-241, uranium-233, and
					 uranium-235. Neither natural nor depleted uranium is fissile material.
"Fluoroscopic imaging assembly" means a subsystem in which
					 x-ray photons produce a fluoroscopic image. It includes the image receptor(s)
					 such as the image intensifier and spot-film device, electrical interlocks, if
					 any, and structural material providing linkage between the image receptor and
					 diagnostic source assembly.
"Focal spot (actual)" means the area on the anode of the
					 x-ray tube bombarded by the electrons accelerated from the cathode and from
					 which the useful beam originates.
"Gantry" means that part of the system supporting and
					 allowing possible movements of the radiation head.
"General purpose radiographic x-ray system" means any
					 radiographic x-ray system which, by design, is not limited to radiographic
					 examination of specific anatomical regions.
"Giga-" (G) means one billion times when used in
					 conjunction with a specified unit.
"Gonad shield" means a protective barrier for the testes
					 or ovaries.
"Gray" (Gy) means the SI unit of absorbed dose. One gray
					 is equal to an absorbed dose of one joule per kilogram (one hundred
					 rads).
"Half-value layer" means the thickness of specified
					 material which attenuates the beam of radiation to an extent such that the
					 exposure rate is reduced to one-half of its original value. In this definition,
					 the contribution of all scattered radiation, other than any which might be
					 present initially in the beam concerned, is deemed to be excluded.
"Hazardous waste" means those wastes designated as
					 hazardous by U.S. Environmental Protection Agency regulations in 40 C.F.R. Part
					 261.
"Healing arts" means the medical, dental, chiropractic,
					 podiatric, and veterinary professions.
"Healing arts screening" means the testing of human beings
					 using x-ray machines for the detection or evaluation of health indications when
					 such tests are not specifically and individually ordered by a licensed
					 practitioner of the healing arts legally authorized to prescribe such x-ray
					 tests for the purpose of diagnosis or treatment.
"High radiation area" means an area, accessible to
					 individuals, in which radiation levels could result in an individual receiving
					 a dose equivalent in excess of 0.1 rem (one millisievert) in one hour at thirty
					 centimeters from any source of radiation or from any surface that the radiation
					 penetrates. For purposes of these rules, rooms or areas in which diagnostic
					 x-ray systems are used for healing arts purposes are not considered high
					 radiation areas.
"HRS" means Hawaii Revised Statutes.
"Human use" means the internal or external administration
					 of radiation or radioactive material to human beings.
"HVL" See "Half-value layer".
"Image intensifier" means a device, installed in its
					 housing, which instantaneously converts an x-ray pattern into a corresponding
					 light image of higher energy density.
"Image receptor" means any device, such as a fluorescent
					 screen or radiographic film, which transforms incident x-ray photons either
					 into a visible image or into another form which can be made into a visible
					 image by further transformations.
"Image receptor support" means, for mammographic systems,
					 that part of the system designed to support the image receptor during
					 mammography.
"Individual" means any human being.
"Individual monitoring" means the assessment of:
(1) Dose equivalent by the use of individual monitoring
					 devices or by the use of survey data; or
(2) Committed effective dose equivalent by bioassay or by
					 determination of the time-weighted air concentrations to which an individual
					 has been exposed, that is, DAC-hours.
"Individual monitoring devices" means devices designed to
					 be worn by a single individual for the assessment of dose equivalent. For
					 purposes of these rules, individual monitoring equipment and personnel
					 monitoring equipment are equivalent terms. Examples of individual monitoring
					 devices are film badges, thermoluminescent dosimeters (TLDs), pocket ionization
					 chambers, and personal air sampling devices.
"Industrial radiography" means the examination of the
					 macroscopic structure of materials by nondestructive methods using sources of
					 ionizing radiation to produce radiographic images.
"Inherent filtration" means the filtration of the useful
					 beam provided by the permanently installed components of the tube housing
					 assembly.
"Inspection" means an official examination or observation
					 including but not limited to, tests, surveys, and monitoring to determine
					 compliance with rules, orders, requirements, and conditions of the
					 department.
"Interlock" means a device arranged or connected such that
					 the occurrence of an event or condition is required before a second event or
					 condition can occur or continue to occur.
"Internal dose" means that portion of the dose equivalent
					 received from radioactive material taken into the body.
"Interruption of irradiation" means the stopping of
					 irradiation with the possibility of continuing irradiation without resetting of
					 operating conditions at the control panel.
"Ionizing radiation" means any radiation consisting of
					 charged particles having sufficient kinetic energy to produce ionization by
					 collision, or uncharged particles which can liberate directly ionizing
					 particles or can initiate a nuclear transformation, or a mixture of both
					 charged and uncharged particles.
"Irradiation" means the exposure of matter to ionizing
					 radiation.
"Isocenter" means a fixed point in space located at the
					 center of the smallest sphere through which the central axis of the beams
					 passes in all conditions.
"Kilo-" (k) means one thousand times when used in
					 conjunction with a specified unit.
"Kilovolts peak" (See "Peak tube potential").
"kV" means kilovolts.
"kVp" (See "Peak tube potential").
"kWs" means kilowatt second.
"Landfill" means a disposal facility or part of a facility
					 at which solid waste is permanently placed in or on land and which is not a
					 landspreading facility.
"Landspreading facility" means a facility that applies
					 sludges or other solid wastes onto or incorporates solid waste into the soil
					 surface at greater than vegetative utilization and soil conditioner and/or
					 immobilization rates.
"Lead equivalent" means the thickness of lead affording
					 the same attenuation, under specified conditions, as the material in
					 question.
"Leakage radiation" means radiation emanating from the
					 diagnostic or therapeutic source assembly except for:
(1) The useful beam; and
(2) Radiation produced when the exposure switch or timer is
					 not activated.
"Leakage technique factors" means the technique factors
					 associated with the diagnostic source assembly which are used in measuring
					 leakage radiation. They are defined as follows:
(1) For diagnostic source assemblies intended for capacitor
					 energy storage equipment, the maximum-rated peak tube potential and the
					 maximum-rated number of exposures in an hour for operation at the maximum-rated
					 peak tube potential with the quantity of charge per exposure being ten
					 millicoulombs, i.e., ten milliampere seconds, or the minimum obtainable from
					 the unit, whichever is larger.
(2) For diagnostic source assemblies intended for field
					 emission equipment rated for pulsed operation, the maximum-rated peak tube
					 potential and the maximum-rated number of x-ray pulses in an hour for operation
					 at the maximum-rated peak tube potential.
(3) For all other diagnostic source assemblies, the
					 maximum-rated peak tube potential and the maximum-rated continuous tube current
					 for the maximum-rated peak tube potential.
"License" means a written authorization issued by the
					 department in accordance with the rules adopted by the department, when used
					 without reference to the U.S. Nuclear Regulatory Commission, agreement state,
					 or other state.
"Licensee" means any person who is issued a license by the
					 department and is legally obligated to have a license with the department
					 pursuant to these rules.
"Light field" means 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.
"Limits" (See "Dose limits").
"Line-voltage regulation" means the difference between the
					 no-load and the load line potentials expressed as a percent of the load line
					 potential. It is calculated using the following equation: Percent line-voltage
					 regulation = 100 (Vn-Vl)/Vl where Vn = No-load line potential and VI = Load
					 line potential.
"Local components" mean part of an analytical x-ray system
					 and include areas that are struck by x-rays such as radiation source housings,
					 port and shutter assemblies, collimators, sample holders, cameras, goniometers,
					 detectors, and shielding, but do not include power supplies, transformers,
					 amplifiers, readout devices, and control panels.
"Lost or missing licensed material" means licensed
					 material whose location is unknown. This definition includes licensed material
					 that has been shipped but has not reached its planned destination and whose
					 location cannot be readily traced in the transportation system.
"mA" means milliampere.
"mAs" means milliampere second.
"Major processor" means a user processing, handling, or
					 manufacturing radioactive material exceeding Type A quantities as unsealed
					 sources or material, or exceeding four times Type B quantities as sealed
					 sources, but does not include nuclear medicine programs, universities,
					 industrial radiographers, or small industrial programs. Type A and B quantities
					 are defined in 10 C.F.R. §71. 4.
"Maximum line current" means the root-mean-square current
					 in the supply line of an x-ray machine operating at its maximum rating.
"Mega-" (M) means a million times when used in conjunction
					 with a specified unit.
"Member of the public" means an individual in a controlled
					 or unrestricted area. However, an individual is not a member of the public
					 during any period in which the individual receives an occupational dose.
"Micro-" (µ) means one-millionth of when used in
					 conjunction with a specified unit.
"Milli-" (m) means one-thousandth of when used in
					 conjunction with a specified unit.
"Minor" means an individual less than eighteen years of
					 age.
"Misadministration" means the administration of:
(1) External beam radiation therapy involving the wrong
					 patient, wrong treatment modality, or wrong treatment site; when the treatment
					 consists of three or fewer fractions and the calculated total administered dose
					 differs from the total prescribed dose by more than ten percent of the total
					 prescribed dose; when the calculated weekly administered dose is thirty percent
					 greater than the weekly prescribed dose; or when the calculated total
					 administered dose differs from the total prescribed dose by more than twenty
					 percent of the total prescribed dose;
(2) A therapeutic radiopharmaceutical dosage involving the
					 wrong patient, wrong radiopharmaceutical, or wrong route of administration, or
					 when the administered dosage differs from the prescribed dosage by more than
					 twenty percent of the prescribed dosage;
(3) A gamma stereotactic radiosurgery radiation dose
					 involving the wrong patient or wrong treatment site, or when the calculated
					 total administered dose differs from the total prescribed dose by more than ten
					 percent of the total prescribed dose;
(4) A teletherapy radiation dose involving the wrong
					 patient, wrong mode of treatment, or wrong treatment site, or when the
					 treatment consists of three or fewer fractions and the calculated total
					 administered dose differs from the total prescribed dose by more than ten
					 percent of the total prescribed dose, or when the calculated weekly
					 administered dose is thirty percent greater than the weekly prescribed dose, or
					 when the calculated total administered dose differs from the total prescribed
					 dose by more than twenty percent of the total prescribed dose;
(5) A brachytherapy radiation dose involving the wrong
					 patient, wrong radionuclide, or wrong treatment site (excluding, for permanent
					 implants, seeds that were implanted in the correct site but migrated outside
					 the treatment site), or involving a sealed source that is leaking, or when, for
					 a temporary implant, one or more sealed sources are not removed upon completion
					 of the procedure, or when the calculated administered dose to the treatment
					 site differs from the prescribed dose by more than twenty percent of the
					 prescribed dose;
(6) A diagnostic radiopharmaceutical dosage, both involving
					 the wrong patient, wrong radiopharmaceutical, wrong route of administration, or
					 when the administered dosage differs by more than twenty percent of the
					 prescribed dosage, and when the dose to the patient exceeds five rems (fifty
					 millisieverts) effective dose equivalent or fifty rems (five hundred
					 millisieverts) dose equivalent to any individual organ. "Mobile nuclear
					 medicine service" means the transportation and medical use of radioactive
					 material.
"Mobile x-ray equipment" (See "X-ray equipment").
"Monitoring" means the measurement of radiation,
					 radioactive material concentrations, surface area activities or quantities of
					 radioactive material and the use of the results of these measurements to
					 evaluate potential exposures and doses. For purposes of these rules, radiation
					 monitoring and radiation protection monitoring are equivalent terms.
"Moving beam therapy" means radiation therapy with
					 relative displacement of the useful beam and the patient during irradiation. It
					 includes arc therapy, skip therapy, and rotational therapy.
"Multiple tomogram system" means a computed tomography
					 x-ray system which obtains x-ray transmission data simultaneously during a
					 single scan to produce more than one tomogram.
"Nano-" (n) means one-billionth of when used in
					 conjunction with a specified unit.
"NARM" means any naturally-occurring and/or
					 accelerator-produced radioactive material. It does not include byproduct,
					 source, or special nuclear material.
"Natural radioactivity" means radioactivity of naturally
					 occurring nuclides.
"New equipment" means systems subject to subchapter 14
					 which were manufactured after January 1, 1985.
"Noise" means the standard deviation of the fluctuations
					 in CTN expressed as a percentage of the attenuation coefficient of water. Its
					 estimate (Sn) is calculated using the following
					 expression:
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					 Image
where:
CS = Contrast scale
µw = Linear attenuation
					 coefficient of water.
s = Estimated standard deviation of the CTN of picture
					 elements in a specified area of the CT image.
"Nominal tomographic section thickness" means the full
					 width at half-maximum of the sensitivity profile taken at the center of the
					 cross-sectional volume over which x-ray transmission data are collected.
"Nonstochastic effect" means a health effect, the severity
					 of which varies with the dose and for which a threshold is believed to exist.
					 Radiation-induced cataract formation is an example of a nonstochastic effect.
					 For purposes of these rules, a "deterministic effect" is an equivalent
					 term.
"Normal operating procedures" mean step-by-step
					 instructions necessary to accomplish the analysis. These procedures shall
					 include sample insertion and manipulation, equipment alignment, routine
					 maintenance by the licensee, and data recording procedures, which are related
					 to radiation safety.
"Normal treatment distance" means:
(1) For electron irradiation, the virtual source to surface
					 distance along the central axis of the useful beam as specified by the
					 manufacturer for the applicator; and
(2) For x-ray irradiation, the virtual source to isocenter
					 distance along the central axis of the useful beam. For non-isocentric
					 equipment, this distance shall be that specified by the manufacturer.
"Occupational dose" means the dose received by an
					 individual in a restricted area or in the course of employment in which the
					 individual's assigned duties involve exposure to sources of radiation, whether
					 in the possession of the licensee, or other person. Occupational dose does not
					 include dose received: from background radiation, as a patient from medical
					 practices, from voluntary participation in medical research programs, or as a
					 member of the public.
"Open-beam configuration" means an analytical x-ray system
					 in which an individual could accidentally place some part of his body in the
					 primary beam path during normal operation.
"Package" means the packaging together with its
					 radioactive contents as presented for transport.
"Particle accelerator" means any machine capable of
					 accelerating electrons, protons, deuterons, or other charged particles in a
					 vacuum and of discharging the resultant particulate or other radiation into a
					 medium at energies usually in excess of one megaelectron volt.
"Patient" means an individual or animal subjected to
					 healing arts examination, diagnosis, or treatment.
"PBL" (See "Positive Beam Limitation").
"Peak tube potential" means the maximum value of the
					 potential difference across the x-ray tube during an exposure.
"Permanent radiographic installation" means an
					 installation or structure designed or intended for radiography and in which
					 radiography is regularly performed.
"Person" means any individual, partnership, firm,
					 association, public or private corporation, trust estate or any other legal
					 entity.
"Personal supervision" means guidance and instruction
					 provided to a radiographer trainee by a radiographer instructor who is present
					 at the site, in visual contact with the trainee while the trainee is using
					 sources of radiation, and in such proximity that immediate assistance can be
					 given if required.
"Personnel monitoring equipment" (See "Individual
					 monitoring devices").
"Phantom" means a volume of material behaving in a manner
					 similar to tissue with respect to the attenuation and scattering of radiation.
					 This requires that both the atomic number (Z) and the density of the material
					 be similar to that of tissue.
"Picture element" means an elemental area of a
					 tomogram.
"Pico-" (p) means one-trillionth of when used in
					 conjunction with a specified unit.
"PID" (See "Position indicating device").
"Planned special exposure" means an infrequent exposure to
					 radiation, separate from and in addition to the annual occupational dose
					 limits.
"Portable x-ray equipment" (See "X-ray equipment").
"Position indicating device" means a device on dental
					 x-ray equipment used to indicate the beam position and to establish a definite
					 source-surface (skin) distance. It may or may not incorporate or serve as a
					 beam-limiting device.
"Positive beam limitation" means the automatic or
					 semiautomatic adjustment of an x-ray beam to the selected image receptor size,
					 whereby exposures cannot be made without such adjustment.
"Prescribed dosage" means the quantity of
					 radiopharmaceutical activity as documented:
(1) In a written directive; or
(2) Either in the diagnostic clinical procedures manual or
					 in any appropriate record in accordance with the directions of the authorized
					 user for diagnostic procedures.
"Prescribed dose" means:
(1) The total dose and dose per fraction as documented in
					 the written directive for external beam radiotherapy which is an estimation
					 from measured data from a specified therapeutic radiation machine using
					 assumptions that are clinically acceptable for that treatment technique and
					 historically consistent with the clinical calculations previously used for
					 patients treated with the same clinical technique; or
(2) The total dose as documented in the written directive
					 for gamma stereotactic radiosurgery; or
(3) The total dose and dose per fraction as documented in
					 the written directive for teletherapy; or
(4) Either the total source strength and exposure time, or
					 the total dose, as documented in the written directive for
					 brachytherapy.
"Primary beam" means radiation which passes through an
					 aperture of the source housing by a direct path from the x-ray tube or a
					 radioactive source located in the radiation source housing.
"Primary protective barrier" See "Protective
					 barrier".
"Protective apron" means an apron made of radiation
					 absorbing materials used to reduce radiation exposure.
"Protective barrier" means a barrier of radiation
					 absorbing material(s) used to reduce radiation exposure. The types of
					 protective barriers are as follows:
(1) "Primary protective barrier" means the material,
					 excluding filters, placed in the useful beam.
(2) "Secondary protective barrier" means the material which
					 attenuates stray radiation.
"Protective glove" means a glove made of radiation
					 absorbing materials used to reduce radiation exposure.
"Public dose" means the dose received by a member of the
					 public from exposure to sources of radiation either within a licensee's
					 controlled area or in unrestricted areas. It does not include occupational
					 dose, dose received from background radiation, dose received as a patient from
					 medical practices, or dose from voluntary participation in medical research
					 programs.
"Qualified health physicist" means a physicist licensed to
					 provide health physics services.
"Qualified medical physicist" means a physicist licensed
					 to provide medical physics services.
"Quality factor" (Q) means the modifying factor that is
					 used to derive dose equivalent from absorbed dose.
"Quarter" means a period of time equal to one-fourth of
					 the year observed by the licensee, approximately thirteen consecutive weeks,
					 providing that the beginning of the first quarter in a year coincides with the
					 starting date of the year and that no day is omitted or duplicated in
					 consecutive quarters.
"Rad" means 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 (0.01 gray).
"Radiation" means alpha particles, beta particles, gamma
					 rays, x-rays, neutrons, high-speed electrons, high-speed protons, and other
					 particles capable of producing ions. For purposes of these rules, ionizing
					 radiation is an equivalent term. Radiation, as used in these rules, does not
					 include non-ionizing radiation, such as radiowaves or microwaves, visible,
					 infrared, or ultraviolet light.
"Radiation area" means any area, accessible to
					 individuals, in which radiation levels could result in an individual receiving
					 a dose equivalent in excess of 0.005 rem (0.05 millisievert) in one hour at
					 thirty centimeters from the source of radiation or from any surface that the
					 radiation penetrates.
"Radiation detector" means a device which in the presence
					 of radiation provides a signal or other indication suitable for use in
					 measuring one or more quantities of incident radiation.
"Radiation head" means the structure from which the useful
					 beam emerges.
"Radiation machine" means any device capable of producing
					 radiation except those devices with radioactive material as the only source of
					 radiation.
"Radiation safety officer" means an individual who has the
					 knowledge and responsibility to apply appropriate radiation protection
					 regulations.
"Radiation therapy simulation system" means a radiographic
					 or fluoroscopic x-ray system intended for localizing the volume to be exposed
					 during radiation therapy and confirming the position and size of the
					 therapeutic irradiation field.
"Radioactive material" means any solid, liquid, or gas
					 which emits radiation spontaneously.
"Radioactivity" means the transformation of unstable
					 atomic nuclei by the emission of radiation.
"Radiobioassay" (See "Bioassay").
"Radiograph" means an image receptor on which the image is
					 created directly or indirectly by an x-ray pattern and results in a permanent
					 record.
"Radiographer" means any individual in industrial
					 radiography who performs or personally supervises industrial radiographic
					 operations, or any individual in the healing arts who practices radiography on
					 human patients as specified in chapter 11-44.
"Radiographer instructor" means any radiographer who has
					 been authorized by the department to provide on-the-job training to
					 radiographer trainees, relative to industrial radiography.
"Radiographer trainee" means any individual who, under the
					 personal supervision of a radiographer instructor, uses sources of radiation,
					 related handling tools, or radiation survey instruments during the course of
					 his instruction, relative to industrial radiography.
"Radiographic imaging system" means any system whereby a
					 permanent or temporary image is recorded on an image receptor by the action of
					 ionizing radiation.
"Radiographic personnel" means any radiographer,
					 radiographer instructor, or radiographer trainee, relative to industrial
					 radiography.
"Rating" means the operating limits as specified by the
					 component manufacturer.
"Recordable event" means the administration of:
(1) An external beam radiation therapy dose when the
					 calculated weekly administered dose is fifteen percent greater than the weekly
					 prescribed dose;
(2) A radiopharmaceutical or radiation without a written
					 directive where a written directive is required;
(3) A radiopharmaceutical or radiation where a written
					 directive is required without daily recording of each administered
					 radiopharmaceutical dosage or radiation dose in the appropriate record;
(4) A therapeutic radiopharmaceutical dosage when the
					 administered dosage differs from the prescribed dosage by more than ten percent
					 of the prescribed dosage;
(5) A teletherapy radiation dose when the calculated weekly
					 administered dose is fifteen percent greater than the weekly prescribed dose;
					 or
(6) A brachytherapy radiation dose when the calculated
					 administered dose differs from the prescribed dose by more than ten percent of
					 the prescribed dose.
"Recording" means producing a permanent form of an image
					 resulting from x-ray photons.
"Reference man" means a hypothetical aggregation of human
					 physical and physiological characteristics determined by international
					 consensus. These characteristics may be used by researchers and public health
					 workers to standardize results of experiments and to relate biological insult
					 to a common base.
"Reference plane" means a plane which is displaced from
					 and parallel to the tomographic plane.
"Regulations of the U.S. Department of Transportation"
					 means the regulations in 49 C.F.R. Parts 100 - 189.
"Rem" means 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 multiplied by the quality factor (one rem = 0.01
					 sievert).
"Research and development" means:
(1) Theoretical analysis, exploration, or experimentation;
					 or
(2) The extension of investigative findings and theories of
					 a scientific or technical nature into practical application for experimental
					 and demonstration purposes, including the experimental production and testing
					 of models, devices, equipment, materials, and processes. Research and
					 development does not include the internal or external administration of
					 radiation or radioactive material to human beings.
"Residential location" means any area where structures in
					 which people lodge or live are located, and the grounds on which such
					 structures are located including, but not limited to, houses, apartments,
					 condominiums, and garages.
"Respiratory protective equipment" means an apparatus,
					 such as a respirator, used to reduce an individual's intake of airborne
					 radioactive materials.
"Restricted area" means any area access to which is
					 limited by the licensee for purposes of protection of individuals against undue
					 risks from exposure to sources of radiation. A restricted area does not include
					 areas used as residential quarters, but separate rooms in a residential
					 building may be set apart as a restricted area.
"Roentgen" (R) means the special unit of exposure. One
					 roentgen (R) equals 2.58 x 10-4 coulombs per
					 kilogram of air. (See "Exposure").
"Sanitary sewerage" means a system of public sewers for
					 carrying off waste water and refuse, but excluding sewage treatment facilities,
					 septic tanks, and leach fields owned or operated by the licensee.
"Scan" means the complete process of collecting x-ray
					 transmission data for the production of a tomogram. Data can be collected
					 simultaneously during a single scan for the production of one or more
					 tomograms.
"Scan increment" means the amount of relative displacement
					 of the patient with respect to the CT x-ray system between successive scans
					 measured along the direction of such displacement.
"Scan sequence" means a preselected set of two or more
					 scans performed consecutively under preselected CT conditions of
					 operation.
"Scan time" means the period of time between the beginning
					 and end of x-ray transmission data accumulation for a single scan.
"Scattered radiation" means radiation that, during passage
					 through matter, has been deviated in direction. (See "Direct scattered
					 radiation").
"Sealed source" means radioactive material that is
					 permanently bonded or fixed in a capsule or matrix designed to prevent release
					 and dispersal of the radioactive material under the most severe conditions
					 which are likely to be encountered in normal use and handling.
"Secondary protective barrier" (See "Protective
					 barrier").
"Shadow tray" means a device attached to the radiation
					 head to support auxiliary beam limiting material.
"Shallow dose equivalent" (Hs),
					 which applies to the external exposure of the skin or an extremity, means the
					 dose equivalent at a tissue depth of 0.007 centimeter (seven milligrams per
					 centimeter squared) averaged over an area of one square centimeter.
"Shielded-room radiography" means industrial radiography
					 conducted in a room shielded so that radiation levels at every location on the
					 exterior meet the limitations specified in subchapter 4 of these rules.
"Shutter" means a device attached to the tube housing
					 assembly which can intercept the entire cross sectional area of the useful beam
					 and which has a lead equivalency not less than that of the tube housing
					 assembly.
"SI" means an abbreviation of the International System of
					 Units.
"SID" (See "Source-image receptor distance").
"Sievert" (Sv) means the SI unit of any of the quantities
					 expressed as dose equivalent. The dose equivalent in sievert is equal to the
					 absorbed dose in gray multiplied by the quality factor (one sievert = one
					 hundred rem).
"Single tomogram system" means a CT x-ray system which
					 obtains x-ray transmission data during a scan to produce a single
					 tomogram.
"Site boundary" means that line beyond which the land or
					 property is not owned, leased, or otherwise controlled by the licensee.
"Source" means the focal spot of the x-ray tube.
"Source-image receptor distance" means the distance from
					 the source to the center of the input surface of the image receptor.
"Source material" means:
(1) Uranium or thorium, or any combination thereof, in any
					 physical or chemical form; or
(2) Ores that contain by weight one-twentieth of one
					 percent (0.05 percent) or more of uranium, thorium or any combination of
					 uranium and thorium. Source material does not include special nuclear
					 material.
"Source material milling" means any activity that results
					 in the production of byproduct material as defined by definition (2) of
					 byproduct material.
"Source of radiation" means any radioactive material or
					 any device or equipment emitting, or capable of producing radiation.
"Special form radioactive material" means radioactive
					 material which satisfies the following conditions:
(1) It is either a single solid piece or is contained in a
					 sealed capsule that can be opened only by destroying the capsule;
(2) The piece or capsule has at least one dimension not
					 less than five millimeters (0.197 inch); and
(3) It satisfies the test requirements specified by the
					 U.S. Nuclear Regulatory Commission. A special form encapsulation designed in
					 accordance with the U.S. Nuclear Regulatory Commission requirements in effect
					 on June 30, 1983, and constructed before July 1, 1985, may continue to be used.
					 A special form encapsulation either designed or constructed after June 30,
					 1985, shall meet requirements of this definition applicable at the time of its
					 design or construction.
"Special nuclear material" means:
(1) Plutonium, uranium-233, uranium enriched in the isotope
					 233 or in the isotope 235, and any other material that the U.S. Nuclear
					 Regulatory Commission, pursuant to the provisions of section 51 of the Atomic
					 Energy Act of 1954, as amended, determines to be special nuclear material, but
					 does not include source material; or
(2) Any material artificially enriched by any of the
					 foregoing but does not include source material.
"Special nuclear material in quantities not sufficient to
					 form a critical mass" means uranium enriched in the isotope U-235 in quantities
					 not exceeding three hundred fifty grams of contained U-235; uranium-233 in
					 quantities not exceeding two hundred grams; plutonium in quantities not
					 exceeding two hundred grams; or any combination of them in accordance with the
					 following formula: For each kind of special nuclear material, determine the
					 ratio between the quantity of that special nuclear material and the quantity
					 specified above for the same kind of special nuclear material. The sum of such
					 ratios for all of the kinds of special nuclear material in combination shall
					 not exceed one. For example, the following quantities in combination would not
					 exceed the limitation and are within the formula:
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"Specific activity" of a radionuclide means the
					 radioactivity of a radionuclide per unit mass of that nuclide. The specific
					 activity of a material in which the radionuclide is essentially uniformly
					 distributed is the radioactivity per unit mass of the material.
"Spot film" means a radiograph which is made during a
					 fluoroscopic examination to permanently record conditions which exist during
					 that fluoroscopic procedure.
"Spot-film device" means a device intended to transport
					 and/or position a radiographic image receptor between the x-ray source and
					 fluoroscopic image receptor. It includes a device intended to hold a cassette
					 over the input end of an image intensifier for the purpose of making a
					 radiograph.
"SSD" means the distance between the source and the skin
					 entrance plane of the patient.
"Stationary beam therapy" means radiation therapy without
					 relative displacement of the useful beam and the patient during
					 irradiation.
"Stationary x-ray equipment" (See "X-ray
					 equipment").
"Stochastic effect" means a health effect that occurs
					 randomly and for which the probability of the effect occurring, rather than its
					 severity, is assumed to be a linear function of dose without threshold.
					 Hereditary effects and cancer incidence are examples of stochastic effects. For
					 purposes of these rules, probabilistic effect is an equivalent term.
"Storage" means a condition in which a device or source is
					 not being used for an extended period of time, and has been made
					 inoperable.
"Storage area" means any location, facility, or vehicle
					 which is used to store, to transport, or to secure an x-ray system when it is
					 not in use and which is locked or has a physical barrier to prevent accidental
					 exposure, tampering with, or unauthorized removal of the device.
"Stray radiation" means the sum of leakage and scattered
					 radiation.
"Survey" means an evaluation of the radiological
					 conditions and potential hazards incident to the production, use, transfer,
					 release, disposal, or presence of sources of radiation. When appropriate, such
					 evaluation includes, but is not limited to, tests, physical examinations, and
					 measurements of levels of radiation or concentrations of radioactive material
					 present.
"Target" means that part of a radiation head which by
					 design intercepts a beam of accelerated particles with subsequent emission of
					 other radiation.
"Technique factors" means the following conditions of
					 operations:
(1) For capacitor energy storage equipment, peak tube
					 potential in kV and quantity of charge in mAs;
(2) For field emission equipment rated for pulsed
					 operation, peak tube potential in kV and number of x-ray pulses;
(3) 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;
(4) 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 when the scan time and exposure time are equivalent; and
(5) 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.
"Temporary job site" means any location where industrial
					 radiography is performed other than the location(s) listed on the
					 license.
"Termination of irradiation" means the stopping of
					 irradiation in a fashion which shall not permit continuance of irradiation
					 without the resetting of operating conditions at the control panel.
"Test" means the process of verifying compliance with an
					 applicable provisions of this chapter.
"Tomogram" means the depiction of the x-ray attenuation
					 properties of a section through a body.
"Tomographic plane" means that geometric plane which is
					 identified as corresponding to the output tomogram.
"Tomographic section" means the volume of an object whose
					 x-ray attenuation properties are imaged in a tomogram.
"Total effective dose equivalent" (TEDE) means the sum of
					 the deep dose equivalent for external exposures and the committed effective
					 dose equivalent for internal exposures.
"Transport index" means the dimensionless number, rounded
					 up to the first decimal place, placed on the label of a package to designate
					 the degree of control to be exercised by the carrier during transportation. The
					 transport index is the number expressing the maximum radiation level in
					 millirem per hour at one meter from the external surface of the package.
"Tube" means an x-ray tube, unless otherwise
					 specified.
"Tube housing assembly" means the tube housing with tube
					 installed. It includes high-voltage and/or filament transformers and other
					 appropriate elements when such are contained within the tube housing.
"Tube rating chart" means the set of curves which specify
					 the rated limits of operation of the tube in terms of the technique
					 factors.
"Type A quantity" means a quantity of radioactive
					 material, the aggregate radioactivity of which does not exceed
					 A1 for special form radioactive material or
					 A2 for normal form radioactive material.
"Uncontrolled area" means any area access to which is not
					 controlled by the licensee for purposes of protection of individuals from
					 exposure to radiation and radioactive material, and any area used for
					 residential quarters.
"Unrefined and unprocessed ore" means ore in its natural
					 form prior to any processing, such as grinding, roasting, beneficiating, or
					 refining.
"Unrestricted area" means an area, access to which is
					 neither limited nor controlled by the licensee. For purposes of these rules,
					 "uncontrolled area" is an equivalent term.
"Useful beam" means the radiation emanating from the tube
					 housing port or the radiation head and passing through the aperture of the beam
					 limiting device when the exposure controls are in a mode to cause the system to
					 produce radiation.
"Variable-aperture beam-limiting device" means a
					 beam-limiting device which has capacity for stepless adjustment of the x-ray
					 field size at a given SID.
"Very high radiation area" means an area, accessible to
					 individuals, in which radiation levels could result in an individual receiving
					 an absorbed dose in excess of five hundred rads (five grays) in one hour at one
					 meter from a source of radiation or from any surface that the radiation
					 penetrates. (At very high doses received at high dose rates, units of absorbed
					 dose, rad and gray, are appropriate, rather than units of dose equivalent, rem
					 and sievert.)
"Virtual source" means a point from which radiation
					 appears to originate.
"Visible area" means that portion of the input surface of
					 the image receptor over which incident x-ray photons are producing a visible
					 image.
"Waste" means those low-level radioactive wastes that are
					 acceptable for disposal in a land disposal facility. For the purposes of this
					 definition, low-level waste has the same meaning as in the Low-Level
					 Radioactive Waste Policy Act , P.L. 96-573, as amended by P.L. 99-240,
					 effective January 15, 1986; that is, radioactive waste (a) not classified as
					 high-level radioactive waste, spent nuclear fuel, or byproduct material as
					 defined in Section 11e.(2) of the Atomic Energy Act (uranium or thorium
					 tailings and waste) and (b) classified as low-level radioactive waste
					 consistent with existing law and in accordance with (a) by the U.S. Nuclear
					 Regulatory Commission.
"Waste handling licensees" mean persons licensed to
					 receive and store radioactive wastes before disposal.
"Week" means seven consecutive days starting on
					 Sunday.
"Weighting factor" wT for an organ
					 or tissue (T) means the proportion of the risk of stochastic effects resulting
					 from irradiation of that organ or tissue to the total risk of stochastic
					 effects when the whole body is irradiated uniformly. For calculating the
					 effective dose equivalent, the values of wT are:
ORGAN DOSE WEIGHTING FACTORS
Organ or Tissue
Wt
Gonads
0.25
Breast
0.15
Red bone marrow
0.12
Lung
0.12
Thyroid
0.03
Bone surfaces
0.03
Remainder
0.30a
Whole Body
1.00b
a 0.30 results from 0.06 for each of
					 five "remainder" organs, excluding the skin and the lens of the eye, that
					 receive the highest doses.
b For the purpose of weighting the
					 external whole body dose, for adding it to the internal dose, a single
					 weighting factor, wT = 1.0, has been specified. The use
					 of other weighting factors for external exposure shall be approved on a
					 case-by-case basis until such time as specific guidance is issued.
"Whole body" means, for purposes of external exposure,
					 head, trunk including male gonads, arms above the elbow, or legs above the
					 knee.
"Worker" means an individual engaged in work licensed and
					 controlled by a licensee, but does not include the licensee.
"Working level" (WL) means any combination of short-lived
					 radon daughters in one liter of air that shall result in the ultimate emission
					 of 1.3 x 105 mega electron volts of potential alpha
					 particle energy. The short-lived radon daughters are -- for radon-222:
					 polonium-218, lead-214, bismuth-214, and polonium-214; and for radon-220:
					 polonium-216, lead-212, bismuth-212, and polonium-212.
"Working level month" (WLM) means an exposure to one
					 working level for one hundred seventy hours -- two thousand working hours per
					 year divided by twelve months per year is approximately equal to one hundred
					 seventy hours per month.
"Written directive" means an order in writing for a
					 specific patient, dated and signed by an authorized user before the
					 administration of a radiopharmaceutical or radiation, except as specified in
					 (6) containing the following information:
(1) For external beam radiotherapy, total dose, dose per
					 fraction, treatment site and overall treatment period; or
(2) For a therapeutic administration of a
					 radiopharmaceutical; the radiopharmaceutical, dosage, and route of
					 administration; or
(3) For gamma stereotactic radiosurgery: target
					 coordinates, collimator size, plug pattern, and total dose; or
(4) For teletherapy: the total dose, dose per fraction,
					 treatment site, and overall treatment period; or
(5) For high-dose-rate remote afterloading brachytherapy:
					 the radionuclide, treatment site, and total dose; or
(6) For all other brachytherapy, before implantation: the
					 radionuclide, number of sources, and source strengths; and after implantation
					 but before completion of the procedure: the radionuclide, treatment site, and
					 total source strength and exposure time (or, equivalently, the total
					 dose).
"X-ray exposure control" means a device, switch, button or
					 other similar means by which an operator initiates and/or terminates the
					 radiation exposure. The x-ray exposure control may include such associated
					 equipment such as timers and back-up timers.
"X-ray equipment" means an x-ray system, subsystem, or
					 component thereof. Types of x-ray equipment are as follows:
(1) "Mobile x-ray equipment" means x-ray equipment mounted
					 on a permanent base with wheels and/or casters for moving while completely
					 assembled.
(2) "Portable x-ray equipment" means x-ray equipment
					 designed to be hand-carried.
(3) "Stationary x-ray equipment" means x-ray equipment
					 which is installed in a fixed location.
"X-ray field" means 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.
"X-ray high-voltage generator" means a device which
					 transforms electrical energy from the potential supplied by the x-ray control
					 to the tube operating potential. The device may also include means for
					 transforming alternating current to direct current, filament transformers for
					 the x-ray tube(s), high-voltage switches, electrical protective devices, and
					 other appropriate elements.
"X-ray system" means an assemblage of components for the
					 controlled production of x-rays. It 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. Additional components which function
					 with the system are considered integral parts of the system.
"X-ray tube" means any electron tube which is designed to
					 be used primarily for the production of x-rays.
"Year" means the period of time beginning in January used
					 to determine compliance with the provisions of these rules. The licensee may
					 change the starting date of the year used to determine compliance provided that
					 the change is made at the beginning of the year and that no day is omitted or
					 duplicated in consecutive years.