As used in these regulations, each of the following terms shall
have the meaning specified in this regulation:
(a)"Cabinet radiography using radiation
machines" means industrial radiography that is conducted in an enclosed,
interlocked cabinet that prevents the radiation machine from operating unless
all openings are securely closed and that is sufficiently shielded so that
every location on the cabinet's exterior meets the conditions for an
unrestricted area as specified in
K.A.R. 28-35-214a.
(b)"Cabinet X-ray system" means an X-ray
system with the X-ray tube installed in an enclosure, called a cabinet," that
is independent from existing architectural structures except the floor on which
the cabinet could be placed. The cabinet is intended for the following
purposes:
(1) To contain at least that portion
of a material being irradiated;
(2)
to provide radiation attenuation; and
(3) to exclude personnel from the interior of
the cabinet during the generation of X-rays.
This term shall include 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 that is used within a shielded part of
a building, or X-ray equipment that may temporarily or occasionally incorporate
portable shielding, shall not be considered a cabinet X-ray
system.
(c)"Calendar quarter" means at least 12 but
not more than 14 consecutive weeks. The first calendar quarter of each year
shall begin in January. Subsequent calendar quarters shall be arranged so 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. A licensee or registrant
shall not change the method of determining and observing calendar quarters for
purposes of these regulations except at the beginning of a calendar
year.
(d)"Calibration" means the
determination of either of the following:
(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.
(e)"Camera" means a radiographic exposure
device.
(f)"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.
(g)"Cephalometric device" means a device
intended for the radiographic visualization and measurement of the dimensions
of the human head.
(h)"Certifiable
cabinet X-ray system" means an existing, uncertified X-ray system that has been
modified to meet the certification requirements specified in
21 C.F.R.
1020.40, dated April 1, 2019, which is hereby
adopted by reference.
(i)"Certificate holder" means a person that
has been issued a certificate of compliance or other package approval by the
commission.
(j)"Certificate of
compliance" and "CoC" mean the certificate issued by the commission under
subpart D of 10 C.F.R. part
71, approving the design of a package for the
transportation of radioactive material.
(k)"Certificate of registration" means a
document issued by the department, the commission, or an agreement state given
sealed source and device registry authority by the commission acknowledging the
registration of a sealed source or device containing a sealed source.
(l)"Certified cabinet X-ray system" means a
cabinet X-ray system that has been certified as manufactured and assembled as
specified in 21 C.F.R.
1020.40, which is adopted by reference in
subsection (h).
(m)"Certified
components" means the components of X-ray systems that are subject to
regulations promulgated under public law
90-602, the radiation control for
health and safety act of 1968 as amended.
(n)"Certified system" means any X-ray system
that has one or more certified components.
(o)"Certifying entity" means an independent
certifying organization or state regulatory program meeting the requirements in
K.A.R. 28-35-293.
(p)"Changeable
filter" means any filter, exclusive of inherent filtration, that can be removed
from the useful beam through any electronic, mechanical, or physical
process.
(q)"Chelating agent" means
amine polycarboxylic acids, hydroxycarboxylic acids, gluconic acids, and
polycarboxylic acids.
(r)"Class"
means a classification scheme for inhaled material according to its rate of
clearance from the pulmonary region of the lung. For the purposes of these
regulations, lung class" and inhalation class" shall be considered equivalent
terms. Materials are classified as D, W, or Y, which applies to the following
range of clearance half-times:
(1) For class
D, fewer than 10 days;
(2) for
class W, from 10 through 100 days; and
(3) for class Y, more than 100
days.
(s)"Coefficient of
variation" and "C" mean the ratio of the standard deviation to the mean value
of a population of observations. This ratio is estimated using the following
equation:
Click here
to view image
where
s = Estimated standard deviation of the population
x = Mean value of observations in sample
xii = ith observation in sample
(t)"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.
(u)"Collimator" means a radiation shield that
is placed at the end of a guide tube or directly onto a radiographic exposure
device to restrict the size of the radiation beam when the sealed source is
cranked into position to make a radiographic exposure.
(v)"Committed dose equivalent" and "HT,50 "
mean 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.
(w)"Committed effective dose equivalent" and
"HE,50" mean 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 = wTHT,50).
(x)"Computed tomography" means the production
of a tomogram by the acquisition and computer processing of X-ray transmission
data, including by cone beam-computed tomography.
(y)"Consortium" means an association of
medical use licensees and a positron emission tomography (PET) radionuclide
production facility in the same geographical area that jointly own or share 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
shall be located at an educational institution, a federal facility, or a
medical institution.
(z)"Contact
therapy" means therapy in which the X-ray tube port is put in contact with, or
within five centimeters of, the surface being treated.
(aa)"Contact therapy system" means a
therapeutic radiation machine with a short target-to-skin distance (TSD),
usually less than five centimeters.
(bb)"Contamination" means the presence of a
radioactive substance on a surface in quantities of more than 0.4
Bq/cm2 (1x10-5
µCi/cm2) for beta and gamma emitters and
low-toxicity alpha emitters, or 0.04 Bq/cm2
(1x10-6
µCi/ cm2) for all
other alpha emitters.
(cc)"Control
cable" means the cable that is connected to the source assembly and used to
drive the source to and from the exposure location.
(dd)"Control drive mechanism" means a device
that enables the source assembly to be moved into and out of the exposure
device.
(ee)"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.
(ff)"Control panel" means that part of the
X-ray system where the switches, knobs, push buttons, and other hardware
necessary for manually setting the technique factors are mounted.
(gg)"Control tube" means a protective sheath
for guiding the control cable. The control tube connects the control drive
mechanism to the radiographic exposure device.
(hh)"Cooling curve" means the graphical
relationship between the heat units stored and the cooling time.
(ii)"Criticality safety index" and "CSI" have
the meaning specified for"criticality safety index (CSI)" in
10 C.F.R.
71.4, dated January 1, 2019. This definition
is hereby adopted by reference.
(jj)"Curie" means a unit of activity. One
curie (Ci) is the quantity of radioactive material that decays at the rate of
3.7 Ãx2014; 1010 transformations per second (tps).
Commonly used submultiples of the curie are the millicurie and the microcurie.
One millicurie (m Ci) = 0.001 curie = 3.7 Ãx2014; 107
tps. One microcurie (µCi) = 0.000001 curie = 3.7 Ãx2014;
104 tps.