Ohio Administrative Code
Title 3701:1 - Radiation Control
Chapter 3701:1-66 - Radiation Generating Equipment
Section 3701:1-66-01 - Definitions
Universal Citation: OH Admin Code 3701:1-66-01
Current through all regulations passed and filed through March 18, 2024
(A) As used in this chapter:
(1) "Air kerma" means the sum of the initial
kinetic energy of all charged ionizing particles liberated by uncharged
ionizing radiation in a given mass of air. The unit for air kerma is joules per
kilogram which is given the special name of gray (Gy). To determine air kerma
in Gy from exposure in units of roentgens (R) multiply exposure by the
conversion factor 0.00876 Gy/R.
(2)
"Air kerma rate" or " (AKR)" means the air kerma
per unit time.
(3) "Aluminum
equivalent" means the thickness of type 1100 aluminum alloy affording the same
attenuation, under specified conditions, as the material in question.
(4)
"Automatic exposure control" or "(AEC)" means a
device which automatically controls one or more technique factors in order to
obtain, at a preselected location, a required quantity of radiation.
(5)
"Beam-limiting device" means a collimator which provides a means to restrict
the dimensions of the x-ray field.
(6)
"Bone
densitometry equipment" means radiation-generating equipment used for the
medical purpose of quantifying bone density and mineral content by x-ray
measurements through the bone and adjacent tissues.
(7) "C-arm fluoroscope" means a fluoroscopic
x-ray system in which the image receptor and the x-ray tube housing assembly
are connected or coordinated to maintain a spatial relationship. Such a system
allows a change in the direction of the beam axis with respect to the patient
without moving the patient.
(8)
"Calibration" means the determination of the response or reading of an
instrument relative to a series of known radiation values over the range of the
instrument, or the radiation output of a source of radiation relative to a
standard.
(9) "Coefficient of
variation" means the ratio of the standard deviation to the mean value of the
observations.
(10) "Collimator"
means a device or mechanism by which the x-ray beam is restricted in
size.
(11) "Computed radiography"
means a system that utilizes a photostimulable phosphor (PSP) plate for
capturing radiographic images. The components of the system include, at a
minimum, the PSP plate and a computed radiography reader which laser scans the
exposed plate, collects the stimulated light and ultimately creates the digital
image.
(12) "Computed tomography
"or" (CT)" means an imaging procedure that uses
multiple x-ray transmission measurements and computer programs to generate
tomographic images.
(13) "Control
panel" means that part of the radiation-generating equipment used for setting
the technique factors.
(14) "CT
conditions of operation" means all selectable parameters governing the
operation of CT radiation-generating equipment including, but not limited to,
nominal image thickness, filtration, milliampere (mA), kilovoltage peak (kVp),
and scan time.
(15) "CT noise"
means the per cent standard deviation of the fluctuations in CTN expressed as a
percentage of the attenuation coefficient of water.
(16) "CT number "or" (CTN)" means the number used to represent the
x-ray attenuation associated with each elemental area of the CT
image.
(17) "Cumulative air kerma"
means the total air kerma accrued from the beginning of an examination or
procedure and includes all contributions from fluoroscopic and radiographic
irradiation.
(18) "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.
(19)
"Dental
equipment" means radiation-generating equipment used for dental
radiography.
(20)
"Digital radiography" or "(DR)" means a general
radiography system that utilizes an imaging plate to capture and produce a
digital image for immediate viewing without the use of a laser scanning
cassette reader.
(21) "Direct
scattered radiation" means scattered
radiation which has been deviated once in direction only by materials
irradiated by the useful beam.
(22) "Executive
administration" means individuals employed in the hospital's administration and
having the authority to expend capital funds, approve personnel actions, and
implement changes to hospital policy and procedure.
(23) "Filter" means
material placed in the useful beam to preferentially attenuate selected
radiations.
(24) "Fluoroscopic irradiation time" means the
cumulative duration of x-ray tube activation in any fluoroscopic mode of
operation.
(25)
Fluoroscopic equipment" means radiation-generating
equipment used for real time imaging of internal structures for medical
purposes.
(26)
"Fluoroscopically-guided interventional (FGI)
procedures" means an interventional diagnostic or therapeutic procedure
performed via percutaneous or other access routes, usually with local
anesthesia or intravenous sedation, which uses external ionizing radiation in
the form of fluoroscopy to localize or characterize a lesion, diagnostic site,
or treatment site, to monitor the procedure, and to control and document
therapy. This statement is focused on the FGI subset of potentially high-dose
procedures.
(27)
"Fluoroscopy" means a technique for generating x-ray
images and presenting them simultaneously and continuously as visible
images.
(28)
"Full time training in medical physics" means having
been engaged in the practice of clinical medical physics for a minimum of
eighteen hundred hours within twelve consecutive months, under the supervision
of a board-certified medical physicist.
(29)
"Full time work
experience" means a minimum of eighteen hundred hours of work experience earned
within twelve consecutive months.
(30)
"General purpose
radiographic equipment" means stationary, mobile, and portable
radiation-generating equipment used for medical purpose, but does not include
dental intraoral, panoral, mammography, bone densitometry, computed tomography,
fluoroscopy or spot film imaging and equipment used in radiation
therapy.
(31) "Half-value layer (HVL)" means the thickness of
specified material which attenuates the beam of radiation to an extent such
that the AKR is reduced by one-half of its original value.
(32)
"Hand-held radiation-generating equipment" means x-ray equipment that is
specifically designed to be held in the hand during operation.
(33)
"Handle" means receive, possess, use, store, transfer, install, service, or
dispose of radiation-generating equipment unless possession is solely for the
purpose of transportation.
(34) "Hybrid imaging
system" means a combination of systems that separately produce anatomic and
functional images in very close temporal proximity without the need for patient
repositioning and allow images to be co-registered and fused. These systems may
be used for purposes including, but not limited to, attenuation correction,
localization, registration, or fusion, but not used independently for
diagnosis.
(35)
"Image intensifier" means a device, installed in its
housing, which instantaneously converts an x-ray pattern into a corresponding
light image of higher intensity.
(36) "Image receptor"
means any device that transforms incident
x-ray photons into either a visible image or another form that can be made into
a visible image by further transformation. In those cases, where means are
provided to preselect a portion of the image receptor, the term "image
receptor" means the preselected portion of the device.
(37)
"Individual responsible for radiation protection (IRRP)" means an individual
designated by the registrant who has the knowledge and responsibility for
overall radiation safety and the quality assurance program at the facility, to
include daily radiation safety operations and compliance with the
rules.
(38) "Interventional procedure" means an invasive
procedure that utilizes radiation-generating equipment for diagnostic or
therapeutic purposes.
(39) "Kilovoltage
peak (kVp)" means the maximum value of the electrical potential difference
between the cathode and the anode of the x-ray tube during an
exposure.
(40)
"Last image hold" means an image obtained either by
retaining one or more fluoroscopic images, which may be temporarily integrated,
at the end of a fluoroscopic exposure or by initiating a separate and distinct
radiographic exposure automatically and immediately in conjunction with
termination of the fluoroscopic exposure.
(41) "Lateral
fluoroscope" means the portion of a biplane system consisting of an x-ray tube
housing assembly and an image receptor that are fixed in position to produce a
horizontal x-ray beam.
(42) "Lead
equivalent" means the thickness of lead affording the same attenuation, under
specified conditions, as the material in question.
(43) "Leakage
radiation" means all radiation coming from within the x-ray tube housing except
the useful beam.
(44) "Licensed practitioner" means an individual
licensed by the state of Ohio pursuant to:
(a)
Chapter 4715. of the Revised Code to practice dentistry;
(b) Chapter 4731. of the Revised Code to
practice medicine or surgery or osteopathic medicine or surgery;
(c) Chapter 4731. of the Revised Code to
practice podiatry;
(d) Chapter
4741. of the Revised Code to practice veterinary medicine;
(e) Chapter 4734. of the Revised Code to
practice chiropractic medicine; and
(f) Chapter 4723. of the Revised Code to
practice as a clinical nurse specialist within the scope of practice of his or
her collaborating physician and in accordance with the
standard care arrangement.
(g) Chapter 4730. of the Revised Code to
practice as a physician assistant within the scope of practice of his or her
supervising physician and in accordance with the utilization plan approved by
the state medical board.
(45) "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.
(46)
"Medical event"
means one or more of the following criteria have occurred to a human
patient:
(a)
Unintended skin dose to the same area in a single procedure greater than 2
sievert (200 rem);
(b)
Unintended dose other than skin dose in a single
procedure greater than:
(i)
0.5 sievert (50 rem) to any organ; or
(ii)
0.05 sievert (5
rem) effective dose equivalent;
(c)
Wrong patient or
wrong site for entire procedure when the resultant dose is:
(i)
Greater than 0.5
sievert (50 rem) to any organ; or
(ii)
Effective dose
equivalent greater than or equal to 0.05 sievert (5 rem).
(47) "Medical, Medical
use" or "Medical purpose" means using radiation-generating equipment to
irradiate human beings or animals for diagnostic, localization, or other
healing arts purposes.
(48) "Milliampere
(mA)" means the measurement of tube current which reflects the number of
electrons flowing from the cathode to the anode of an x-ray tube during x-ray
production.
(49) "Mobile radiation-generating equipment" means
x-ray equipment permanently mounted on a base with wheels or castors for moving
while completely assembled and is not used in a fixed location.
(50)
"Patient" means an individual or animal subjected to radiation for the purposes
of examination or therapy.
(51) "Portable
radiation-generating equipment" means radiation-generating equipment designed
to be hand-carried.
(52) "Primary protective barrier" means a barrier
sufficient to attenuate the useful beam to the required radiation
level.
(53) "Protective apron" means an apron made of
radiation-attenuating materials used to reduce radiation exposure.
(54)
"Protective barrier" means a barrier of radiation-attenuating materials used to
reduce radiation exposure.
(55) "Protective
glove" means a glove made of radiation-attenuating materials used to reduce
radiation exposure.
(56) "Radiation expert" means an individual
who meets
the qualifications of:
(a) Applicable
paragraphs of rule
3701:1-66-03
of the Administrative Code;
(b)
Paragraph (D) of rule
3701-83-45
of the Administrative Code, for any facility
providing radiation therapy services;
(c) Paragraph (C)(3) of rule
3701-83-52
of the Administrative Code for CT equipment, or
paragraph (F)(3) of rule
3701-83-52
of the Administrative Code for fluoroscopy, at
any facility providing CT or fluoroscopy services; or
(d)
21 C.F.R.
900.12(a)(3) (as
effective on the effective date of
this rule) for any facility providing mammography services.
(57) "Radiation worker" means an individual engaged in
activities registered by the department and controlled by the
registrant.
(58) "Reference plane" means a plane which is
displaced from and parallel to the computed tomographic plane.
(59)
"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.
(60) "Scan sequence"
means a pre-selected set of two or more scans performed consecutively under
pre-selected CT conditions of operation.
(61) "Scattered radiation" means radiation that,
during passage through matter, has been deviated in direction.
(62)
"Secondary protective barrier" means a barrier sufficient to attenuate stray
ionizing radiation to a required level.
(63) "Source" means
the point of origin of the useful radiation beam.
(64) "Source-to-image
receptor distance" or "(SID)" means the distance
from the source to the center of the input surface of the image
receptor.
(65) "Source-to-skin distance"
or "(SSD)" means the distance between the source and the skin of the
patient.
(66)
"Spot film" means a radiograph which is made during a
fluoroscopic examination to permanently record conditions which exist during
the fluoroscopic procedure
(67) "Stationary
radiation-generating equipment" means equipment which is installed in a fixed
location.
(68) "Stray radiation" means leakage radiation or
scattered radiation.
(69) "Table
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.
(70) "Technique
factors" means any combination of the following which determines the exposure
rate: kVp, mA, time, x-ray pulses, or the product of tube current and exposure
time in mAs.
(71) "Tomogram" means the depiction of the radiation
attenuation properties of a section through a body.
(72) "Tomographic
plane" means that geometric plane which is identified as corresponding to the
output tomogram.
(73) "Tube housing assembly" means the tube housing
with tube installed. It includes high voltage or filament transformers and
other appropriate elements when they are contained within the tube
housing.
(74)
"Unintended Dose" or "Unintended Skin Dose" means a
patient radiation dose resulting from an error or equipment malfunction during
a procedure.
(75) "Useful beam" means that part of the radiation
which passes through the window, aperture, cone, or other collimating device of
the source housing.
(76)
"Veterinary radiation-generating equipment" means
radiation-generating equipment used for veterinary radiography.
(77)
"Visible area" means that portion of the input surface of the image receptor
over which incident x-ray photons are producing a visible image.
(78)
"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 air kerma rate is
one-fourth of the maximum in the intersection.
(B) Terms appearing in this chapter, which are not defined in this rule, may be defined in rule 3701:1-38-01 of the Administrative Code.
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