Iowa Administrative Code › Agency 641 - Public Health Department › Chapter 38 - General Provisions for Radiation Machines and Radioactive Materials › Rule 641-38.2 - Definitions

Current through Register Vol. 47, No. 3, July 24, 2024
As used in these rules, these terms have the definitions set
				forth below and are adopted by reference and included herein for 641-Chapters
				39 to 45.
"Absorbed dose"
means the energy imparted by
				ionizing radiation per unit mass of irradiated material. It is determined as
				the quotient of dE by dM, where dE is the mean energy imparted by ionizing
				radiation to matter of mass dM. The SI unit of absorbed dose is joule per
				kilogram and the special name of the unit of absorbed dose is the gray (Gy).
				The units of absorbed dose are the gray (Gy) and the rad.
"Absorbeddose rate"
means absorbed dose per
				unit time, for machines with timers, or dose monitor unit per unit time for
				linear accelerators.
"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 1 MeV. For purposes of this definition,
				"particle accelerator" is an equivalent term.
"Accelerator-producedmaterial"
means any
				material made radioactive by a particle accelerator.
"Act"
means 1984 Iowa Acts, chapter 1286,
				relating to regulation of radiation machines and radioactive materials. (Iowa
				Code chapter 136C)
"Activity"
means the rate of disintegration or
				transformation or decay of radioactive material. The units of activity are the
				curie (Ci) and the becquerel (Bq).
"Adult"
means an individual 18 years of age or
				older.
"Agency"
means the Iowa department of public
				health.
"Agreement state"
means any state with which
				the U.S. Nuclear Regulatory Commission or the U.S. Atomic Energy Commission has
				entered into an effective agreement under Subsection 274b of the Atomic Energy
				Act of 1954 as amended (73 Stat. 689). The state of Iowa is an agreement state
				as of January 1, 1986.
"Airborne radioactive material"
means any
				radioactive material dispersed in the air in the form of dusts, fumes,
				particles, mists, vapors, or gases.
"Airborne radioactivity area"
means a room,
				enclosure, or area in which airborne radioactive material (composed wholly or
				partly of licensed material) exists in concentrations (1) in excess of the
				derived air concentrations (DACs) specified in Appendix A of 641-Chapter 40; 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 12
				DAC-hours.
"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).
"Air-purifying respirator"
means a respirator
				with an air-purifying filter, cartridge, or canister that removes specific air
				contaminants by passing ambient air through the air-purifying element.
"Annually"
means at least once every 365
				days.
"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 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 nuclear energy and licensed
				or registered 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
				the employee or agent who assembles components into an X-ray system that is
				subsequently used to provide professional or commercial services.
"Assigned protection factor (APF)"
means the
				expected workplace level of respiratory protection that would be provided by a
				properly functioning respirator or a class of respirators to properly fitted
				and trained users. Operationally, the inhaled concentration can be estimated by
				dividing the ambient airborne concentration by the APR
"Atmosphere-supplying respirator"
means a
				respirator that supplies the respirator user with breathing air from a source
				independent of the ambient atmosphere, and includes supplied-air respirators
				(SARs) and self-contained breathing apparatus (SCBA) units.
"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 or from past nuclear accidents such as Chernobyl that contribute to
				background radiation and are not under the control of the licensee. "Background
				radiation" does not include sources of radiation from radioactive materials
				regulated by the agency.
"Barrier"
(see "Protective barrier").
"Beam axis"
means a line from the source
				through the centers of the X-ray fields.
"Beam-limiting device"
means a field defining
				collimator, integral to the system, which provides a means to restrict the
				dimensions of the X-ray field or useful beam.
"Beam monitoring system"
means a system
				designed and installed in the radiation head to detect and measure the
				radiation present in the useful beam.
"Becquerel"
(Bq) means the SI unit of
				activity. One becquerel is equal to 1 disintegration or transformation per
				second (dps or tps).
"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.
"Bone densitometry unit"
means a medical
				device which uses electronically produced ionizing radiation to determine the
				density of bone structures of human patients.
"Brachytherapy"
means a method of radiation
				therapy in which sealed sources are utilized to deliver a radiation dose at a
				distance of up to a few centimeters, by surface, intracavitary, intraluminal,
				or interstitial application.
"Brachytherapy source"
means a radioactive
				source or a manufacturer-assembled source train or a combination of these
				sources that is designed to deliver a therapeutic dose within a distance of a
				few centimeters.
"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;
2. The tailings or wastes produced by the extraction or
				concentration of uranium or thorium from any 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;
3. Any discrete source of radium-226 that is produced,
				extracted, or converted after extraction, before, on, or after August 8,2005,
				for use for a commercial, medical, or research activity or any material
				that:
* Has been made radioactive by use of a particle accelerator;
				and
* Is produced, extracted, or converted after extraction,
				before, on, or after August 8, 2005, for use for a commercial, medical, or
				research activity; and
4. Any discrete source of naturally occurring radioactive
				material, other than source material, that:
* The Nuclear Regulatory Commission, in consultation with the
				Administrator of the Environmental Protection Agency, the Secretary of Energy,
				the Secretary of Homeland Security, and the head of any other appropriate
				federal agency, determines would pose a threat to the public health and safety
				or the common defense and security similar to the threat posed by a discrete
				source of radium-226; and
* Before, on, or after August 8, 2005, is extracted or
				converted after extraction for use in a commercial, medical, or research
				activity.
"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
				641-40.26(136C).
"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 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 or registrant shall change the method of determining
				calendar quarters for purposes of these rules except at the beginning of a
				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.
"CFR"
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.
"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.
"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 50-year period following the intake.
"Committed effective dose equivalent"
(Hesq)
				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 =
				[SIGMA]wT,HT,50).
"Consignment"
means each shipment of a package
				or groups of packages or load of radioactive material offered by a shipper for
				transport.
"Consortium"
means an association of medical
				use licensees and a PET radionuclide production facility in the same
				geographical area that jointly own or share in the operation and maintenance
				cost of the PET radionuclide production facility that produces PET
				radionuclides for use in producing radioactive drugs within the consortium for
				noncommercial distributions among its associated members for medical use. The
				PET radionuclide production facility within the consortium must be located at
				an educational institution, a federal facility or a medical facility.
"Constraint"
or
"dose
				constraint"
means a value above which specified licensee actions are
				required.
"Controlled area"
means an area, outside of a
				restricted area but inside the site boundary, access to which can be limited by
				the licensee or registrant for any reason.
"Critical group"
means the group of
				individuals reasonably expected to receive the greatest exposure to residual
				radioactivity for any applicable set of circumstances.
"Curie"
means a unit of quantity of
				radioactivity. One curie (Ci) is that quantity of radioactive material which
				decays at the rate of 3.7E+10 transformations per second (tps).
"Decay-in-storage"
means the holding of
				radioactive material having half-lives of less than or equal to 120 days until
				it decays to background levels. Before disposal in ordinary trash, the material
				must have been held for a minimum often half-lives and its radioactivity is
				indistinguishable from background as indicated by a survey meter set on its
				most sensitive scale with no interposing shielding.
"Decommission"
means to remove a facility or
				site safely from service and reduce residual radioactivity to a level that
				permits:
1. Release of the property for unrestricted use and termination
				of the license; or
2. Release of the property under restricted conditions and
				termination of the license.
"Deep dose equivalent"
(Hd), means the dose equivalent at a tissue depth of 1
				centimeter (1000 mg/cm2).
"Demand respirator"
means an
				atmosphere-supplying respirator that admits breathing air to the facepiece only
				when a negative pressure is created inside the facepiece by inhalation.
"Depleteduranium"
means the source material
				uranium in which the isotope uranium-235 is less than 0.711 weight percent of
				the total uranium present. Depleted uranium does not include special nuclear
				material.
"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 radiopharmaceutical, dosage, and route
				of administration.
"Diagnostic imaging system"
means an
				assemblage of components for the generation, emission, reception,
				transformation, storage and visual display of the resultant image.
"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
				which are designed and used for irradiation of any part of the human or animal
				body for the purpose of diagnosis or visualization.
"Direct supervision"
means guidance and
				instruction by a qualified individual who is physically present and watching
				the performance of the radiological operation or procedure and in such
				proximity that contact can be maintained and immediate assistance can be given
				as required.
"Discrete source"
means a radionuclide that
				has been processed so that its concentration within a material has been
				purposely increased for use for commercial, medical, or research
				activities.
"Disposable respirator"
means a respirator for
				which maintenance is not intended and that is designed to be discarded after
				excessive breathing resistance, sorbent exhaustion, physical damage, or
				end-of-service-life renders it unsuitable for use. Examples of this type of
				respirator are a disposable half-mask respirator or a disposable escape-only
				self-contained breathing apparatus (SCBA).
"Distinguishable from background"
means that
				the detectable concentration of a radionuclide is statistically different from
				the background concentration of that radionuclide in the vicinity of the site
				or, in the case of structures, in similar materials using adequate measurement
				technology, survey, and statistical techniques.
"Dose"
is a generic term that means absorbed
				dose, dose equivalent, effective dose equivalent, committed dose equivalent,
				committed effective dose equivalent, total organ 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.
"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=
				[SIGMA]wTHT).
"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 or registered radioactive materials. This
				includes entry or exit portals of sufficient size to permit human entry,
				irrespective of their intended use.
"Exposure"
means being exposed to ionizing
				radiation or to radioactive material.
"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) (see 641-38.2 (136C) for
				SI equivalent coulomb per kilogram). When not underlined as above or when
				indicated as 'exposure' or (X), the term "exposure" has a more general meaning
				in these rules.
"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. See 641-subrule 42.1(2) for
				definitions of "lower extremities" and "upper extremities" for purposes of
				certification standards.
"Facility"
means the location, building,
				vehicle, or complex under one administrative control, at which radioactive
				material is stored or used or at which one or more radiation machines are
				installed, located or used.
"FDA"
means the Food and Drug
				Administration.
"Filtering facepiece (dust mask)"
means a
				negative pressure particulate respirator with a filter as an integral part of
				the facepiece or with the entire facepiece composed of the filtering medium,
				which is not equipped with elastomeric sealing surfaces and adjustable
				straps.
"Fit factor"
means a quantitative estimate of
				the fit of a particular respirator to a specific individual, and typically
				estimates the ratio of the concentration of a substance in ambient air to its
				concentration inside the respirator when worn.
"Fit test"
means the use of a protocol to
				qualitatively or quantitatively evaluate the fit of a respirator on an
				individual.
"Former U.S. Atomic Energy Commission (AEC) or U.S.
				Nuclear Regulatory Commission (NRC) licensed facilities"
means nuclear
				reactors, nuclear fuel reprocessing plants, uranium enrichment plants, or
				critical mass experimental facilities where AEC or NRC licenses have been
				terminated.
"Generally applicable environmental radiation
				standards"
means standards issued by the U.S. Environmental Protection
				Agency (EPA) under the authority of the Atomic Energy Act of 1954, as amended,
				that impose limits on radiation exposures or levels, or concentrations or
				quantities of radioactive material, in the general environment outside the
				boundaries of locations under the control of persons possessing or using
				radioactive material.
"Gray (Gy)"
means the SI unit of absorbed
				dose. One gray is equal to an absorbed dose of 1 joule per kilogram (1 Gy=100
				rad).
"Half-value layer (HVL)"
means the thickness
				of a specified material which attenuates X-radiation or gamma radiation to an
				extent such that the air kerma rate, exposure rate or absorbed dose rate is
				reduced to one-half of the value measured without the material at the same
				point. 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 CFR Part 261.
"Healing arts"
means the occupational fields
				of diagnosing or treating disease, providing health care and improving health
				by the practice of medicine, osteopathy, chiropractic, podiatry, dentistry,
				nursing, veterinary medicine, and supporting professions, such as physician
				assistants, nurse practitioners, radiologic technologists, and dental
				hygienists.
"Helmet"
means a rigid respiratory inlet
				covering that also provides head protection against impact and
				penetration.
"High dose-rate remote afterloader"
means a
				brachytherapy device that remotely delivers a dose rate in excess of 1200 rads
				(12 gray) per hour at the point or surface where the dose is prescribed.
"High-level radioactive waste"
or
"HLW"
means (1) irradiated reactor fuel; (2) liquid wastes
				resulting from the operation of the first cycle solvent extraction system, or
				equivalent, and the concentrated wastes from subsequent extraction cycles, or
				equivalent, in a facility for reprocessing irradiated reactor fuel; and (3)
				solids into which such liquid wastes have been converted.
"High radiation area"
means an area,
				accessible to individuals, in which radiation levels from radiation sources
				external to the body could result in an individual's receiving a dose
				equivalent in excess of 0.1 rem (1 mSv) in 1 hour at 30 centimeters from any
				source of radiation or 30 centimeters from any surface that the radiation
				penetrates.
"Highway route controlled quantity"
means a
				quantity within a single package which exceeds:
1. 3,000 times the A1 value of the
				radionuclides as specified in
				49 CFR
				173.435 for special form Class 7
				(radioactive) material;
2. 3,000 times the A2value of the
				radionuclides as specified in
				49 CFR
				173.435 for normal form Class 7 (radioactive)
				material; or
3. 1,000 TBq (27,000 Ci), whichever is least.
"Hood"
means a respiratory inlet covering that
				completely covers the head and neck and may also cover portions of the
				shoulders and torso.
"Human use"
means the internal or external
				administration of radiation or radioactive material to human beings.
"Individual"
means any human being.
"Individual monitoring"
means the assessment
				of:
1. Dose equivalent by the use of devices designed to be worn by
				an individual 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. See the definition of DAC-hours in
				641-Chapter 40.
"Individual monitoring devices"
means devices
				designed to be worn by a single individual for the assessment of dose
				equivalent. For purposes of these rules, "personnel dosimeter" and "dosimeter"
				are equivalent terms. Examples of individual monitoring devices are film
				badges, thermoluminescent dosimeters (TLDs), pocket ionization chambers,
				optically stimulated luminescent (OSL) devices, and personal air sampling
				devices.
"Industrial radiography"
means an examination
				of the structure of materials by nondestructive methods, utilizing ionizing
				radiation to make radiographic images.
"Inspection"
means an official examination or
				observation including, but not limited to, tests, surveys, and monitoring to
				determine compliance with rules, regulations, orders, requirements, and
				conditions of the agency.
"Instrument traceability"
means, for ionizing
				radiation measurements, the ability to show that an instrument has been
				calibrated at specified time intervals using a national standard or a transfer
				standard. If a transfer standard is used, the calibration must be from a
				laboratory accredited by a program which required continuing participation in
				measurement quality assurance with the National Institute of Standards and
				Technology or other equivalent national or international program.
"Interlock"
means a device preventing the
				start or continued operation of equipment unless certain predetermined
				conditions prevail.
"Internal dose"
means that portion of the dose
				equivalent received from radioactive material taken into the body.
"Ionizing radiation."
See "Radiation."
"Irradiation"
means the exposure of a living
				being or matter to ionizing radiation.
"Kilovolt (kV) (kilo electron volt (keV))"
means the energy equal to that acquired by a particle with one electron charge
				in passing through a potential difference of 1000 volts in a vacuum.
"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.
"Lens dose equivalent (LDE)"
applies to the
				external exposure of the lens of the eye and is taken as the dose equivalent at
				a tissue depth of 0.3 centimeter (300
				mg/cm2).
"License"
means a license issued by the agency
				in accordance with the rules adopted by the agency.
"Licensed (or registered) material"
means
				radioactive material received, possessed, used, transferred or disposed of
				under a general or specific license (or registration) issued by the
				agency.
"Licensed practitioner"
means a person
				licensed or otherwise authorized by law to practice medicine, osteopathy,
				chiropractic, podiatry, or dentistry in Iowa, or certified as a physician
				assistant as defined in Iowa Code section
				148C.1, subsection 6,
				and is authorized to prescribe X-ray tests for the purpose of diagnosis or
				treatment.
"Licensee"
means any person who is licensed by
				the agency in accordance with these rules and the Act.
"Licensing state"
means any state with
				regulations equivalent to the suggested state regulations for control of
				radiation relating to, and an effective program for, the regulatory control of
				NARM and which has been granted final designation by the Conference of
				Radiation Control Program Directors, Inc.
"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."
"Loose-fitting facepiece"
means a respiratory
				inlet covering that is designed to form a partial seal with the face.
"Lost or missing licensed (or registered) source of
				radiation"
means licensed (or registered) source of radiation whose
				location is unknown. This definition includes licensed (or registered) material
				that has been shipped but has not reached its planned destination and whose
				location cannot be readily traced in the transportation system.
"Lot tolerance percent defective"
means,
				expressed in percent defective, the poorest quality in an individual inspection
				lot that should be accepted.
"Low dose-rate remote afterloader"
means a
				brachytherapy device that remotely delivers a dose rate of less than or equal
				to 200 rads (2 gray) per hour at the point or surface where the dose is
				prescribed.
"mA"
means milliampere.
"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 this rule.
"Mammography"
means the radiography of the
				breast except as defined in 641-subrule 41.6(1).
"Mammography unit"
means an assemblage of
				components for the production of X-rays for use during mammography, including,
				at a minimum: an X-ray generator, an X-ray control, a tube housing assembly, a
				beam-limiting device, and the supporting structures for these
				components.
"Manual brachytherapy"
means a type of
				brachytherapy in which the brachytherapy sources (e.g., seeds, ribbons) are
				manually placed topically on or inserted either into the body cavities that are
				in close proximity to a treatment site or directly into the tissue
				volume.
"Medical use"
means the intentional internal
				or external administration of radioactive material or the radiation therefrom
				to patients or human research subjects under the supervision of an authorized
				user.
"Medium dose-rate remote afterloader"
means a
				brachytherapy device that remotely delivers a dose rate of greater than 200
				rads (2 gray), but less than 1200 rads (12 gray) per hour at the point or
				surface where the dose is prescribed.
"Member of the public"
means any individual
				except when that individual is receiving an occupational dose.
"Minor"
means an individual less than 18 years
				of age.
"Misadministration"
means the administration
				of:
Radiation doses received from linear accelerator therapy, deep
				X-ray machine therapy or superficial therapy; involving;
Administration of external beam radiation that results, or will
				result, in unintended permanent functional damage to an organ or a
				physiological system as determined by a physician.
A dose that differs from the prescribed dose by more than 5 rem
				(0.05 sievert) effective dose equivalent, 50 rem (0.5 sievert) to an organ or
				tissue, or 50 rem (0.5 sievert) shallow dose equivalent to the skin; and
				either:
(1) The total dose delivered differs from the prescribed dose
				by 20 percent or more; or
(2) The fractionated dose delivered differs from the prescribed
				dose for a single fraction by 50 percent or more.
A dose that exceeds 5 rem (0.05 sievert) effective dose
				equivalent, 50 rem (0.5 sievert) to an organ or tissue, or 50 rem (0.5 sievert)
				shallow dose equivalent to the skin from either of the following:
(1) An administration of the wrong treatment modality.
(2) An administration to the wrong patient or human research
				subject.
A dose to the skin or an organ or tissue other than the
				treatment site that exceeds by 50 rem (0.5 sievert) to an organ or tissue and
				50 percent or more of the dose expected from the administration defined in the
				written directive.
"Monitoring (radiation monitoring, radiation protection
				monitoring)"
means the measurement of radiation levels, radioactive
				material concentrations, surface area concentrations or quantities of
				radioactive material and the use of the results of these measurements to
				evaluate potential exposures and doses.
"NARM"
means any naturally occurring or
				accelerator-produced radioactive material. It does not include byproduct,
				source, or special nuclear material.
"Natural radioactivity"
means radioactivity of
				naturally occurring nuclides. For the purpose of meeting the definition of a
				licensing state by the Conference of Radiation Control Program Directors, Inc.,
				(CRCPD), NARM refers only to discrete sources of NARM. Diffuse sources of NARM
				are excluded from consideration by the CRCPD for licensing state designation
				purposes.
"Negative pressure respirator (tightfitting)"
means a respirator in which the air pressure inside the facepiece is negative
				during inhalation with respect to the ambient air pressure outside the
				respirator.
"Nuclear Regulatory Commission (NRC)"
means
				the U.S. Nuclear Regulatory Commission or its duly authorized
				representatives.
"Occupational dose"
means the dose received by
				an individual in the course of employment in which the individual's assigned
				duties involve exposure to radiation or to radioactive material from licensed
				or unlicensed and registered or unregistered sources of radiation, whether in
				the possession of the licensee, registrant, or other person. Occupational dose
				does not include dose received from background radiation, from any medical
				administration the individual has received, from exposure to individuals
				administered sources of radiation or radioactive material and released in
				accordance with 641-subrule 41.2(27), from voluntary participation in medical
				research programs, or as a member of the public.
"Package"
means the packaging together with
				its radioactive contents as presented for transport.
"Particle accelerator."
See
				"Accelerator."
"Patient"
means an individual or animal
				subjected to healing arts examination, diagnosis or treatment.
"Peak tube potential"
means the maximum value
				of the potential difference across the X-ray tube during an exposure.
"Person"
means any individual, corporation,
				partnership, firm, association, trust, estate, public or private institution,
				group, agency, political subdivision of this state, any other state or
				political subdivision or agency thereof, and any legal successor,
				representative, agent, or agency of the foregoing, but shall not include
				federal government agencies.
"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.
"Pharmacist"
means an individual licensed by
				this state to compound and dispense drugs, prescriptions, and poisons.
"Physician"
means a person who is currently
				licensed in Iowa to practice medicine and surgery, osteopathic medicine and
				surgery, or osteopathy.
"Positive pressure respirator"
means a
				respirator in which the pressure inside the respiratory inlet covering exceeds
				the ambient air pressure outside the respirator.
"Positron emission tomography (PET) radionuclide
				production facility"
means a facility operating a cyclotron or
				accelerator for the purpose of producing PET radionuclides.
"Powered air-purifying respirator (PAPR)"
means an air-purifying respirator that uses a blower to force the ambient air
				through air-purifying elements to the inlet covering.
"Preceptor"
means an individual who provides,
				directs, or verifies training and experience required for an individual to
				become an authorized user, an authorized medical physicist, an authorized
				nuclear pharmacist, a radiation safety officer, or an associate radiation
				safety officer.
"Prescribed dosage"
means the specified
				activity or range of activity of unsealed radioactive material as
				documented:
1. In a written directive; or
2. In accordance with the directions of the authorized user for
				procedures performed in 641-subrules 41.2(31) and 41.2(33).
"Prescribed dose"
means:
1. For gamma stereotactic radiosurgery, the total dose as
				documented in the written directive;
2. For teletherapy, particle accelerators and X-ray therapy
				systems, the total dose and dose per fraction as documented in the written
				directive;
3. For manual brachytherapy, either the total source strength
				and exposure time or the total dose, as documented in the written directive;
				or
4. For remote brachytherapy afterloaders, the total dose and
				dose per fraction as documented in the written directive.
"Pressure demand respirator"
means a positive
				pressure atmosphere-supplying respirator that admits breathing air to the
				facepiece when the positive pressure is reduced inside the facepiece by
				inhalation.
"Primary dose monitoring system"
means a
				system which will monitor the useful beam during irradiation and which will
				terminate irradiation when a preselected number of dose monitor units have been
				delivered.
"Primary protective barrier"
(see "Protective
				barrier").
"Principal activities,"
as used in this part,
				means activities authorized by the license which are essential to achieving the
				purpose(s) for which the license was issued or amended. Storage during which no
				licensed material is accessed for use or disposal and activities incidental to
				decontamination or decommissioning are not principal activities.
"Protective barrier"
means a barrier 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 a
				barrier sufficient to attenuate the stray radiation to the required
				degree.
"Public dose"
means the dose received by a
				member of the public from exposure to radiation or to radioactive material
				released by a licensee, registrant, or other person, or to any other source of
				radiation under the control of a licensee, registrant, or other person. It does
				not include occupational dose or doses received from background radiation, from
				any medical administration the individual has received, from exposure to
				individuals administered sources of radiation or radioactive material and
				released under 641-subrule 41.2(27) or from voluntary participation in medical
				research programs.
"Pyrophoric material"
means any liquid that
				ignites spontaneously in dry or moist air at or below 130° F (54.4° C)
				or solid, other than one classed as an explosive, which under normal conditions
				is liable to cause fires through friction, retained heat from manufacturing or
				processing, or which can be ignited readily and, when ignited, burns so
				vigorously and persistently as to create a serious transportation, handling, or
				disposal hazard. Included are spontaneously combustible and water-reactive
				materials.
"Qualified expert"
means an individual having
				the knowledge and training to measure ionizing radiation, to evaluate safety
				techniques, and to advise regarding radiation protection needs. For example,
				individuals certified in the appropriate field by the American Board of
				Radiology, the American Board of Medical Physics, or the American Board of
				Health Physics, or those having equivalent qualifications. With reference to
				the calibration of radiation therapy equipment, an individual having, in
				addition to the above qualifications, training and experience in the clinical
				applications of radiation physics to radiation therapy, for example,
				individuals certified in Therapeutic Radiological Physics or X-Ray and Radium
				Physics by the American Board of Radiology, or those having equivalent
				qualifications.
"Qualitative fit test (QLFT)"
means a
				pass-fail fit test to assess the adequacy of respirator fit that relies on the
				individual's response to the test agent.
"Quality factor"
(Q) means the modifying
				factor, listed in Tables I and II of 38.4(4), that is used to derive dose
				equivalent from absorbed dose.
"Quantitative fit test (QNFT)"
means an
				assessment of the adequacy of respirator fit by numerically measuring the
				amount of leakage into the respirator.
"Rad"
means the special unit of absorbed dose.
				One rad is equal to an absorbed dose of 100 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 nonionizing 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 0.05 mSv (0.005 rem) in 1 hour at 30 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, by either direct or indirect means, provides a
				signal or other indication suitable for use in measuring one or more quantities
				of incident radiation.
"Radiation dose."
See "Dose."
"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 and has been assigned such responsibility by the
				licensee or registrant.
"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."
"Radiographic imaging system"
means any system
				whereby a permanent or semipermanent image is recorded on an image receptor by
				the action of ionizing radiation.
"Radionuclide"
means a radioactive element or
				a radioactive isotope.
"Registrant"
means any person who is
				registered with the agency or is legally obligated to register with the agency
				pursuant to these rules and the Act.
"Registration"
means registration with the
				agency in accordance with the rules adopted by the agency.
"Regulations of the U.S. Department of
				Transportation"
means the regulations in 49 CFR 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 (1 rem = 0.01
				sievert).
"Reportable medical event"
means the medical
				event:
a. In which, except for an event that results from patient
				intervention:
(1) The administration of byproduct material or radiation from
				byproduct material, except permanent implant brachytherapy, results in:
1. A dose that differs from the prescribed dose or dose that
				would have resulted from the prescribed dosage by more than 5 rem (0.05 Sv)
				effective dose equivalent, 50 rem (0.5 Sv) to an organ or tissue, or 50 rem
				(0.5 Sv) shallow dose equivalent to the skin; and
* The total dose delivered differs from the prescribed dose by
				20 percent or more;
* The total dosage delivered differs from the prescribed dosage
				by 20 percent or more or falls outside the prescribed dosage range; or
* The fractionated dose delivered differs from the prescribed
				dose, for a single fraction, by 50 percent or more.
2. A dose that exceeds 5 rem (0.05 Sv) effective dose
				equivalent, 50 rem (0.5 Sv) to an organ or tissue, or 50 rem (0.5 Sv) shallow
				dose equivalent to the skin from any of the following:
* An administration of the wrong radioactive drug containing
				byproduct material or the wrong radionuclide for a brachytherapy
				procedure;
* An administration of a radioactive drug containing byproduct
				material by the wrong route of administration;
* An administration of a dose or dosage to the wrong individual
				or human research subject;
* An administration of a dose or dosage delivered by the wrong
				mode of treatment; or
* A leaking sealed source.
3. A dose to the skin or an organ or tissue other than the
				treatment site that exceeds by:
* 50 rem (0.5 Sv) or more the expected dose to that site from
				the procedure if the administration had been given in accordance with the
				written directive prepared or revised before administration; and
* 50 percent or more the expected dose from the procedure if
				the administration had been given in accordance with the written directive
				prepared or revised before administration;
(2) For permanent implant brachytherapy, the administration of
				byproduct material or radiation from byproduct material (excluding sources that
				were implanted in the correct site but migrated outside the treatment site)
				that results in:
1. The total source strength administered differing by 20
				percent or more from the total source strength documented in the
				postimplantation portion of the written directive;
2. The total source strength administered outside of the
				treatment site exceeding 20 percent of the total source strength documented in
				the postimplantation portion of the written directive; or
3. An administration that includes any of the following:
* The wrong radionuclide;
* The wrong individual or human research subject;
* Sealed source(s) implanted directly into a location
				discontiguous from the treatment site, as documented in the postimplantation
				portion of the written directive; or
* A leaking sealed source resulting in a dose that exceeds 50
				rem (0.5 Sv) to an organ or tissue.
b. Resulting from intervention of a patient or human research
				subject in which administration of byproduct material or radiation from
				byproduct material results or will result in unintended permanent functional
				damage to an organ or a physiological system, as determined by a
				physician.
"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.
"Residual radioactivity"
means radioactivity
				in structures, materials, soils, groundwater, and other media at a site
				resulting from activities under the licensee's control. This includes
				radioactivity from all licensed and unlicensed sources used by the licensee,
				but excludes background radiation. It also includes radioactive materials
				remaining at the site as a result of routine or accidental releases of
				radioactive material at the site and previous burials at the site, even if
				those burials were made in accordance with the provisions of 641-Chapter 40 or
				any previous state or federal licenses, rules or regulations.
"Restricted area"
means an area, access to
				which is limited by the licensee or registrant for the purpose of protecting
				individuals against undue risks from exposure to sources of radiation. A
				restricted area shall not include any areas used for residential quarters,
				although a separate room or rooms in a residential building may be set apart as
				a restricted area.
"Roentgen"
means the special unit of exposure.
				One roentgen (R) equals 2.58 x 10-4coulombs/kilogram
				of air (see "Exposure" and 38.4(4)).
"Scattered radiation"
means ionizing radiation
				emitted by interaction of ionizing radiation with matter, the interaction being
				accompanied by a change in direction of the radiation. Scattered primary
				radiation means that scattered radiation which has been deviated in direction
				only by materials irradiated by the useful beam.
"Sealed source"
means radioactive material
				that is encased in a capsule designed to prevent leakage or escape of the
				radioactive material.
"Sealed Source and Device Registry"
or
"SSDR"
means the national registry that contains all the
				registration certificates, generated by both the NRC and the agreement states,
				that summarizes the radiation safety information for the sealed sources and
				devices and describes the licensing and use conditions approved for the
				product.
"Secondary dose monitoring system"
means a
				system which will terminate irradiation in the event of failure of the primary
				dose monitoring system.
"Secondaryprotective barrier"
(see "Protective
				barrier").
"Self-contained breathing apparatus (SCBA)"
means an atmosphere-supplying respirator for which the breathing air source is
				designed to be carried by the user.
"Shallow dose equivalent"
				(Hs)
, which applies to the external exposure of
				the skin of the whole body or the skin of an extremity, means the dose
				equivalent at a tissue depth of 0.007 centimeter (7
				mg/cm2).
"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 the abbreviation for the
				International System of Units.
"Sievert"
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 (1 Sv = 100
				rem).
"Simulator (radiation therapy simulation system)
				"
means any X-ray system intended for localizing the volume to be
				exposed during radiation therapy and reproducing the position and size of the
				therapeutic irradiation field.
"Site area emergency"
means events may occur,
				are in progress, or have occurred that could lead to a significant release of
				radioactive material and that could require a response by off-site response
				organizations to protect persons off site.
"Site boundary"
means that line beyond which
				the land or property is not owned, leased, or otherwise controlled by the
				licensee or registrant.
"Source"
means the focal spot of the X-ray
				tube.
"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 1 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.
"Source traceability"
means the ability to
				show that a radioactive source has been calibrated either by the national
				standards laboratory of the National Institute of Standards and Technology or
				by a laboratory which participates in continuing measurement quality assurance
				programs with the National Institute of Standards and Technology or other
				equivalent national or international program.
"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 5 millimeters (0.2 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 prior to July 1, 1985, may continue to be
				used. A special form encapsulation either designed or constructed after June
				30, 1985, must 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 agency declares by order
				to be special nuclear material after 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 350 grams of contained U-235; uranium-233 in
				quantities not exceeding 200 grams; plutonium in quantities not exceeding 200
				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 1. For example, the
				following quantities in combination would not exceed the limitation and are
				within the formula:
Click to view
				image
"SSD"
means the distance between the source
				and the skin entrance plane of the patient (see "Target-to-skin distance
				(TSD)").
"Stray radiation"
means the sum of leakage and
				scattered radiation.
"Supplied-air respirator (SAR)"
or
"airline respirator"
means an atmosphere-supplying respirator
				for which the source of breathing air is not designed to be carried by the
				user.
"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 a physical survey of the location of
				radioactive material and measurements or calculations of levels of radiation or
				concentrations or quantities of radioactive material present.
"Target-to-skin distance (TSD)"
means the
				distance measured along the beam axis from the center of the front surface of
				the X-ray target or electron virtual source scattering foil to the surface of
				the irradiated object or patient.
"Termination of irradiation"
means the
				stopping of irradiation in a fashion which will 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 regulation.
"These rules"
means 641-Chapters 38 to
				45.
"Tight-fitting facepiece"
means a respirator
				inlet covering that forms a complete seal with the face.
"Total effective dose equivalent"
(TEDE) means
				the sum of the effective dose equivalent (for external exposures) and the
				committed effective dose equivalent (for internal exposures).
"Total organ dose equivalent"
(TODE) means the
				sum of the deep dose equivalent and the committed dose equivalent to the organ
				receiving the highest dose as described in
				641-40.86
				(1)
"f"
"Traceable to a national standard."
See
				"Instrument traceability" or "Source traceability."
"Treatment site"
means the anatomical
				description of the tissue intended to receive a radiation dose, as described in
				the written directive.
"Tube"
means an X-ray tube unless otherwise
				specified. See "X-ray tube."
"Tube housing assembly"
means the tube housing
				with tube installed. It includes high-voltage or filament transformers, or
				both, and other appropriate elements when such are contained within the tube
				housing.
"Type A quantity"
means a quantity of
				radioactive material, the aggregate radioactivity of which does not exceed Ai
				for special form radioactive material, or A2, for normal
				form radioactive material as defined in
				10
				CFR 71.4.
"Type B quantity"
means a quantity of
				radioactive material greater than a Type A quantity as defined in
				10CFR 71.4.
"Unrefined and unprocessed ore"
means ore in
				its natural form prior to any processing, such as grinding, roasting,
				beneficiating, or refining. Processing does not include sieving or
				encapsulation of ore or preparation of samples for laboratory analysis.
"Unrestricted area"
means an area to which
				access is neither limited nor controlled by the licensee or registrant. For
				purposes of these rules, "uncontrolled area" is an equivalent term.
"U.S. Department of Energy"
means the
				Department of Energy established by Public Law 95-91, August 4, 1977, 91 Stat.
				565, 42 U.S.C. 7101 et
				seq., to the extent that the department exercises functions formerly vested in
				the U.S. Atomic Energy Commission, its chairman, members, officers and
				components and transferred to the U.S. Energy Research and Development
				Administration and to the administrator thereof pursuant to Sections 104(b),
				(c) and (d) of the Energy Reorganization Act of 1974 ( Public Law 93-438,
				October 11, 1974, 88 Stat. 1233 at 1237, effective January 19, 1975) and
				retransferred to the Secretary of Energy pursuant to Section 301(a) of the
				Department of Energy Organization Act ( Public Law 95-91, August 4, 1977, 91
				Stat. 565 at 577-578,
				42 U.S.C. 7151,
				effective October 1, 1977).
"User seal check (fit check)"
means an action
				conducted by the respirator user to determine if the respirator is properly
				seated to the face. Examples include negative pressure check, positive pressure
				check, irritant smoke check, or isoamyl acetate check.
"Very high radiation area"
means an area,
				accessible to individuals, in which radiation levels from radiation sources
				external to the body could result in an individual's receiving an absorbed dose
				in excess of 500 rad (5 Gy) in 1 hour at 1 meter from a source of radiation or
				1 meter from any surface that the radiation penetrates.
"Waste"
means those low-level radioactive
				wastes containing source, special nuclear, or byproduct material that are
				acceptable for disposal in a land disposal facility. For the purposes of this
				definition, low-level radioactive waste means radioactive waste not classified
				as high-level radioactive waste, transuranic waste, spent nuclear fuel, or
				byproduct material as defined in paragraphs "2," "3" and "4" of the definition
				of "byproduct material" set forth in this chapter.
"Waste handling licensees"
means persons
				licensed to receive and store radioactive wastes prior to disposal or persons
				licensed to dispose of radioactive waste.
"Wedgefilter"
means an added filter effecting
				continuous progressive attenuation on all or part of the useful beam.
"Week"
means seven consecutive days starting
				on Sunday.
"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
				under a license or registration issued by the agency and controlled by a
				licensee or registrant, but does not include the licensee or registrant.
"Working level"
(WL) means any combination of
				short-lived radon daughters in 1 liter of air that will result in the ultimate
				emission of 1.3E+5 MeV of potential alpha particle energy. The short-lived
				radon daughters are-forradon-222: polonium-218, lead-214, bismuth-214,
				andpolonium-214; and for radon-220: polonium-216, lead-212, bismuth-212, and
				polonium-212.
"Working level month"
(WLM) means an exposure
				to 1 working level for 170 hours-2,000 working hours per year divided by 12
				months per year is approximately equal to 170 hours per month.
"Written directive"
means an order in writing
				for a specific patient or human research subject, dated and signed by an
				authorized user prior to the administration of a radiopharmaceutical or by an
				individual qualified by training and experience to conduct particle accelerator
				therapy or radiation for X-ray therapy, as specified in 641-subrule
				41.2(87).
"X-radiation"
means penetrating
				electromagnetic radiation with energy greater than 0.1 kV produced by
				bombarding a metallic target with fast electrons in a high vacuum.
"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 or registrant may change the starting date of the year used to
				determine compliance by the licensee or registrant provided that the change is
				made at the beginning of the year and that no day is omitted or duplicated in
				consecutive years.