Ohio Administrative Code › Title 3701:1 - Radiation Control › Chapter 3701:1-66 - Radiation Generating Equipment › Section 3701:1-66-01 - Definitions

Current through all regulations passed and filed through July 1, 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.