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(35) Dose limits--The permissible upper bounds of radiation
doses established in accordance with this chapter. For purposes of
this section, "limits" is an equivalent term.
(36) Effective dose equivalent (HE )--The
sum of the products of the dose equivalent to the organ or tissue
(HT ) and the weighting factors (WT ) applicable to each of the body organs or
tissues that are irradiated (HE = ΣWT HT ).
(37) Embryo/fetus--The developing human organism from
conception until the time of birth.
(38) Entrance exposure (Entrance air kerma)--The entrance
exposure in air expressed in roentgens or the entrance dose in air
(air kerma) expressed in gray, measured at the point where the center
of the useful beam enters the patient.
(39) Equipment performance evaluations (EPE)--Required
testing performed by a registered service provider at a specified
interval to ensure radiation machines operate in compliance with this
chapter.
(40) Exposure--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 International System of Units (SI) unit of exposure
is the coulomb per kilogram. The roentgen is the special unit of exposure.
For purposes of this section, this term is used as a noun.
(41) Exposure rate (air kerma rate)--The exposure per
unit of time. For purposes of this section, "air kerma rate" is an
equivalent term.
(42) External dose--That portion of the dose equivalent
received from any source of radiation outside the body.
(43) Extremity--Hand, elbow, arm below the elbow, foot,
knee, and leg below the knee. The arm above the elbow and the leg
above the knee are considered part of the whole body.
(44) Field emission equipment--Equipment that uses
an x-ray tube in which electron emission from the cathode is due solely
to the action of an electric field.
(45) Filter--Material placed in the useful beam to
absorb selected radiations preferentially.
(46) Gray (Gy)--The SI unit of absorbed dose. One gray
is equal to an absorbed dose of one joule per kilogram or 100 rad.
(47) Half-value layer (HVL)--The thickness of a specified
material that attenuates the beam of radiation to an extent such that
the exposure rate (air kerma rate) is reduced to one-half of its original
value.
(48) Healing arts--Any system, treatment, operation,
diagnosis, prescription, or practice for the ascertainment, cure,
relief, palliation, adjustment, or correction of any human disease,
ailment, deformity, injury, or unhealthy or abnormal physical or mental
condition.
(49) Hearing--A proceeding to examine an application
or other matter before the agency in order to adjudicate rights, duties,
or privileges.
(50) Human use--For exposure to x-ray radiation from
radiation machines, the external administration of radiation to human
beings for healing arts purposes or research or development specifically
authorized by the agency.
(51) Image receptor--Any device, such as a fluorescent
screen, radiographic film, or digital sensor that transforms incident
x-ray photons either into a visible image or into another form that
can be made into a visible image by further transformations.
(52) Individual--Any human being.
(53) Individual monitoring--The assessment of dose
equivalent to an individual by the use of:
(A) individual monitoring devices; or
(B) survey data.
(54) Individual monitoring devices--Devices designed
to be worn by a single individual for the assessment of dose equivalent.
For purposes of this section, "personnel dosimeter," "dosimeter,"
and "personnel monitoring equipment" are equivalent terms. Examples
of individual monitoring devices include, but are not limited to,
film badges, thermoluminescence dosimeters, optically stimulated luminescence
dosimeters, pocket ionization chambers (pocket dosimeters), and electronic
personal dosimeters.
(55) Informal conference--A meeting held by the agency
with a person to discuss the following:
(A) safety, safeguards, or environmental problems;
(B) compliance with regulatory or registration condition
requirements;
(C) proposed corrective measures, including, but not
limited to, schedules for implementation; and
(D) enforcement options available to the agency.
(56) Inspection--An official thorough examination or
observation, including, but not limited to, records, tests, surveys,
and monitoring to effectively determine compliance with the Act and
requirements of this section, orders, and conditions of the agency.
(57) Institutional Review Board (IRB)--Any board, committee,
or other group formally designated by an institution to review, approve
the initiation of, and conduct periodic review of biomedical research
involving human subjects.
(58) Ionizing radiation--Any electromagnetic or particulate
radiation capable of producing ions, directly or indirectly, in its
passage through matter. Ionizing radiation includes gamma rays and
x-rays, alpha and beta particles, high-speed electrons, neutrons,
and other nuclear particles.
(59) kV--Kilovolt.
(60) kVp--Kilovolt peak (See definition for peak tube
potential).
(61) kWs--Kilowatt-second. It is equivalent to 10 E
3 watt-second, where 1 watt-second =1 kilovolt x 1 milliampere x 1
second.
(62) Lead equivalent--The thickness of lead affording
the same attenuation, under specified conditions, as the material
in question.
(63) Leakage radiation--Radiation emanating from the
diagnostic assembly except for the useful beam and radiation produced
when the exposure switch or timer is not activated.
(64) Lens dose equivalent--The external dose equivalent
to the lens of the eye at a tissue depth of 0.3 centimeters (300 milligrams
per square centimeter).
(65) License--A form of permission given by the agency
to an applicant who has met the requirements for licensing set out
in the Act and this chapter.
(66) Licensed material--Radioactive material received,
possessed, used, or transferred under a general or specific license
issued by the agency.
(67) Licensee--Any person who is licensed by the agency
in accordance with the Act and this chapter.
(68) mA--Milliampere.
(69) mAs--Milliampere-second.
(70) Medical research--The investigation of various
health risks and diseases.
(71) Member of the public--Any individual, except when
that individual is receiving an occupational dose.
(72) Minor--An individual less than 18 years of age.
(73) Mobile service operation--The provision of radiation
machines and personnel at temporary locations for limited time periods.
(74) Monitoring--The measurement of radiation and the
use of the results of these measurements to evaluate potential exposures
and doses. For purposes of this section, "radiation monitoring" and
"radiation protection monitoring" are equivalent terms.
(75) Notice of violation--A written statement prepared
by the agency of one or more alleged infringements of a legally binding
requirement.
(76) Occupational dose--The dose received by an individual
in the course of employment in which the individual's assigned duties
involve exposure to radiation from licensed/registered and unlicensed/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 radioactive
material and released in accordance with this section, from voluntary
participation in medical research programs, or as a member of the
public.
(77) Order--A specific directive contained in a legal
document issued by the agency.
(78) Party--A person designated as such by the ALJ.
A party may consist of the following:
(A) the agency;
(B) an applicant, licensee, registrant, accredited
mammography facility, or certified industrial radiographer; and
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