# Title 33.1 — Department of Environmental Quality

## Article 33.1-10 — Radiological Health Rules

## Chapter 33.1-10-06 — X-Rays in the Healing Arts

or Computed Tomography X-Ray Systems
### § 33.1-10-06-01. Scope.

This chapter establishes requirements, for which a registrant is responsible, for use of x-ray
equipment and imaging systems by or under the supervision of an individual authorized by and
licensed in accordance with state statutes to engage in the healing arts or veterinary medicine. The
requirements of this chapter are in addition to, and not in substitution for, other applicable requirements
of this article.
History: Effective January 1, 2019.
General Authority: NDCC 23.1-03-04; S.L. 2017, ch. 199, § 1
Law Implemented: NDCC 23.1-03-03, 23.1-03-04; S.L. 2017, ch. 199, § 18
### § 33.1-10-06-02. Definitions.

As used in this chapter, the following definitions apply:
1. "Absorbed dose" means the energy imparted by ionizing radiation per unit mass of irradiated
material. The units of absorbed dose are the gray (Gy) and the rad.
2. "Accessible surface" means surface of equipment or of an equipment part that can be touched
by persons without the use of a tool.
3. "Added filtration" means any filtration which is in addition to the inherent filtration.
4. "Air kerma" means kerma in air (see "kerma").
5. "Air kerma rate" means the air kerma per unit of time.
6. "AKR" means air kerma rate.
7. "Allied health" means occupations of medical personnel who are not physicians and are
qualified by special training to undergo cross-training into x-ray as a limited x-ray machine
operator. Refer to appendix G for qualifying professions.
8. "Aluminum equivalent" means the thickness of type 1100 aluminum alloy affording the same
attenuation, under specified conditions, as the material in question. (The nominal chemical
composition of type 1100 aluminum alloy is ninety-nine percent minimum aluminum,
twelve-hundredths percent copper.)

9. "As low as reasonably achievable" (ALARA) means making every reasonable effort to
maintain the exposures to radiation as far below dose limits as is practicable.
10. "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.
11. "Attenuation block" means a block or stack, having dimensions twenty centimeters by twenty
centimeters by three and eight-tenths centimeters, of type 1100 aluminum alloy or other
materials having equivalent attenuation.
12. "Automatic exposure control" means a device which automatically controls one or more
technique factors in order to obtain at a preselected location or locations a required quantity of
radiation (includes devices such as phototimers and ion chambers).
13. "Barrier" (see "protective barrier").
14. "Beam axis" means the axis of rotation of the beam-limiting device from the source through
the centers of the x-ray fields.
15. "Beam-limiting device" means a device which provides a means to restrict the dimensions of
the useful beam.
16. "Biennium" means a two-year cycle.
17. "Board certified" means an individual who has completed an accredited school of medical
radiography or chiropractic radiography and has passed a national registry examination.
18. "Board eligible" means an individual who has obtained eligibility to take a national registry
examination in radiologic technology or chiropractic radiologic technology.
19. "Bone densitometry system" means a medical device which uses electronically produced
ionizing radiation to determine the density of bone structures of human patients.
20. "Calibration" means the determination of:
a. The response or reading of an instrument relative to a series of known radiation values
over the range of the instrument; or
b. The strength of a source of radiation relative to a standard.
21. "C-arm x-ray system" means an x-ray system in which the image receptor and x-ray tube
housing assembly are connected by a common mechanical support system in order to
maintain a desired spatial relationship. This system is designed to allow a change in the
projection of the beam through the patient without a change in the position of the patient.
22. "Cephalometric device" means a device intended for the radiographic visualization and
measurement of the dimensions of the human head.
23. "Certified components" means components of x-ray systems which are subject to regulations
promulgated under the Radiation Control for Health and Safety Act of 1968 [Pub. L. 90-602].
24. "Certified system" means any x-ray system which has one or more certified component or
components.
25. "CEU" (see "continuing education unit").

26. "CFR" means Code of Federal Regulations.
27. "Changeable filters" means any filter, exclusive of inherent filtration, which can be removed
from the useful beam through any electronic, mechanical, or physical process.
28. "Coefficient of variation" or "C" means the ratio of the standard deviation to the mean value of
a set of observations. It is estimated using the following equation:
where:
s = Estimated standard deviation of the population.
= Mean value of observations in sample.
X = ith observation in sample.
i
n = Number of observations in sample.
29. "Computed tomography" means the production of a tomogram by the acquisition and
computer processing of x-ray transmission data.
30. "Contact therapy system" means an x-ray system used for therapy with the x-ray tube port
placed in contact with or within five centimeters of the surface being treated.
31. "Continuing education" means a planned, organized, and administered learning activity that
enhances the knowledge and underlying skills of an x-ray operator.
32. "Continuing education unit" means a unit of measure for continuing education. One continuing
education unit is equal to one contact hour.
33. "Control panel" means that part of the x-ray control upon which are mounted the switches,
knobs, pushbuttons, and other hardware necessary for manually setting the technique factors.
34. "Cooling curve" means the graphical relationship between heat units stored and cooling time.
35. "CT" (see "computed tomography").
36. "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.
37. "Department" means the department of environmental quality.
38. "Detector" (see "radiation detector").
39. "Diagnostic source assembly" means the tube housing assembly with a beam-limiting device
attached.
40. "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.
41. "Diagnostic x-ray system" means an x-ray system designed for irradiation of any part of the
human or animal body for the purpose of diagnosis or visualization.

42. "Direct scattered radiation" means that scattered radiation which has been deviated in
direction only by materials irradiated by the useful beam (see "scattered radiation").
43. "Direct supervision" requires direct observation and observer must be in the room during the
time the x-ray image is obtained.
44. "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.
45. "Dose limits" means the permissible upper bounds of radiation of doses established in
accordance with these rules.
46. "Entrance exposure rate" means the radiation exposure free in air per unit time at the point
where the center of the useful beam enters the patient.
47. "Equipment" (see "x-ray equipment").
48. "Exposure" means being exposed to ionizing radiation.
49. "Field emission equipment" means equipment which uses an x-ray tube in which electron
emission from the cathode is due solely to the action of an electric field.
50. "Filter" means material placed in the useful beam to absorb preferentially selected radiations.
51. "Fluoroscopic imaging assembly" means a subsystem in which x-ray photons produce a
visible image. It includes the image receptor or receptors such as the image intensifier and
spot-film device, electrical interlocks, if any, and structural material providing linkage between
the image receptor and diagnostic source assembly.
52. "Focal spot" means the location projected on the anode of the x-ray tube bombarded by the
electrons accelerated from the cathode and from which the useful beam originates.
53. "General diagnostic operator" means an individual who is American registry of radiologic
technologists (ARRT) or American chiropractic registry of radiologic technologists (ACRRT)
board certified, is or has been board eligible, or has the equivalent educational and clinical
training and received specific authorization from the department.
54. "General purpose radiographic x-ray system" means any radiographic x-ray system which, by
design, is not limited to radiographic examination of specific anatomical regions.
55. "Gonad shield" means a protective barrier for the testes or ovaries.
56. "Gray" (Gy) means the SI unit of absorbed dose. One gray is equal to an absorbed does of
one joule per kilogram or 100 rad.
57. "Half-value layer" means the thickness of 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.
58. "Hand-held dental x-ray equipment" (see "x-ray equipment").
59. "Healing arts" means diagnostic or healing treatment of human and animal maladies, including
the following which are duly licensed by the state of North Dakota for the lawful practice of
medicine and its associated specialties, dentistry, veterinary medicine, osteopathy,
chiropractic, and podiatry.

60. "Healing arts screening" means the testing of human beings using x-ray machines for the
detection or evaluation of health indications when such tests are not specifically and
individually ordered by a licensed practitioner of the healing arts legally authorized to
prescribe such x-ray tests for the purpose of diagnosis or treatment.
61. "Heat unit" means a unit of energy equal to the product of the peak kilovoltage, milliamperes,
and seconds, i.e., kVp x mA x seconds.
62. "HVL" (see "half-value layer").
63. "Image intensifier" means a device, installed in its housing, which instantaneously converts an
x-ray pattern into a corresponding light image of higher energy density.
64. "Image receptor" means any device, such as a fluorescent screen or radiographic film, which
transforms incident x-ray photons either into a visible image or into another form which can be
made into a visible image by further transformations.
65. "Image receptor support" means, for mammographic systems, that part of the system
designed to support the image receptor during a mammographic examination.
66. "Inherent filtration" means the filtration of the useful beam provided by the permanently
installed components of the tube housing assembly.
67. "Inspection" means an official examination or observation, including tests, surveys, and
monitoring to determine compliance with rules, regulations, requirements, and conditions of
the department.
68. "Irradiation" means the exposure of matter to ionizing radiation.
69. "Kerma" means the sum of the initial kinetic energies of all the charged ionizing particles
liberated by uncharged ionizing particles per unit mass of a specified material. The SI unit of
measure is joule per kilogram, or gray (Gy).
70. "Kilovolts peak" (see "peak tube potential").
71. "kV" means kilovolts.
72. "kVp" (see "peak tube potential").
73. "kWs" means kilowatt second. It is equivalent to 103 kV . mA . s, i.e.,
kWs = (X)kV x (Y)mA x (Z)s x 10-3 = XYZ
74. "Lead equivalent" means the thickness of lead affording the same attenuation, under specified
conditions, as the material in question.
75. "Leakage radiation" means radiation emanating from the diagnostic or therapeutic source
assembly except for:
a. The useful beam; and
b. Radiation produced when the exposure switch or timer is not activated.
76. "Leakage technique factors" means the technique factors associated with the diagnostic or
therapeutic assembly which are used in measuring leakage radiation. They are defined as
follows:

a. For diagnostic source assemblies intended for capacitor energy storage equipment, the
maximum-rated peak tube potential and the maximum-rated number of exposures in an
hour for operation at the maximum-rated peak tube potential with the quantity of charge
per exposure being ten millicoulombs, i.e., ten milliampere seconds, or the minimum
obtainable from the unit, whichever is larger.
b. For diagnostic source assemblies intended for field emission equipment rated for pulsed
operation, the maximum-rated peak tube potential and the maximum-rated number of
x-ray pulses in an hour for operation at the maximum-rated peak tube potential.
c. For all other diagnostic or therapeutic source assemblies, the maximum-rated peak tube
potential and the maximum-rated continuous tube current for the maximum-rated peak
tube potential.
77. "Light field" means the area illuminated by light, simulating the radiation field.
78. "Limited x-ray machine operator" means any individual who has completed the necessary
didactic and clinical training required to perform limited scope x-ray procedures.
79. "Linear attenuation coefficient" or "u" means the quotient of dN/N divided by dl when dN/N is
the fraction of uncharged ionizing radiation that experience interactions in traversing a
distance dl in a specified material.
80. "mA" means milliampere.
81. "mAs" means milliampere second.
82. "Milliampere" as used in this chapter applies to x-ray tube current.
83. "Milliampere second" as used in this chapter is the product of the tube current and x-ray
exposure time measured in seconds.
84. "Mobile x-ray equipment" (see "x-ray equipment").
85. "Monitoring" means the measurement of radiation and the use of the measured results to
evaluate potential exposures and doses.
86. "Patient" means an individual or animal subjected to radiation for the purposes of diagnosis or
treatment.
87. "PBL" has the same meaning as "positive beam limitation".
88. "Peak tube potential" means the maximum value of the potential difference across the x-ray
tube during an exposure.
89. "Phantom" means a volume of material behaving in a manner similar to tissue with respect to
the absorption and scattering of the ionizing radiation in question.
90. "Phototimer" means a method for controlling radiation exposures to image receptors by the
amount of radiation which reaches a radiation monitoring device. The radiation monitoring
device is part of an electronic circuit which controls the duration of time the tube is activated
(see "automatic exposure control").
91. "Physician" means a medical doctor, doctor of osteopathy, doctor of podiatry, or chiropractor
licensed by a state or territory of the United States, the District of Columbia, or the
Commonwealth of Puerto Rico.
92. "Portable x-ray equipment" (see "x-ray equipment").

93. "Position indicating device" means a device on dental x-ray equipment used to indicate the
beam position and to establish a definite source surface (skin) distance. It may or may not
incorporate or serve as a beam-limiting device.
94. "Positive beam limitation" means the automatic or semiautomatic adjustment of an x-ray beam
to the size of the selected image receptor, whereby exposures cannot be made without such
adjustment.
95. "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.
96. "Primary protective barrier" (see "protective barrier").
97. "Protective apron" means an apron made of radiation attenuating materials used to reduce
radiation exposure.
98. "Protective barrier" means a barrier of radiation absorbing material or materials used to reduce
radiation exposure. The types of protective barriers are as follows:
a. "Primary protective barrier" means the material, excluding filters, placed in the useful
beam; and
b. "Secondary protective barrier" means the material which attenuates stray radiation.
99. "Protective glove" means a glove made of radiation absorbing materials used to reduce
radiation exposure.
100. "Qualified expert" means an individual having the knowledge, training, and experience 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, or the American board of health physics, or the American board of medical
physics, or those having equivalent qualifications. With reference to the calibration of radiation
therapy equipment, "qualified expert" means 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.
101. "Radiation" means x-rays and gamma rays, which are capable of producing ions. For
purposes of this chapter, ionizing radiation is an equivalent term.
102. "Radiation detector" means a device which in the presence of radiation provides a signal or
other indication suitable for use in measuring one or more quantities of incident radiation.
103. "Radiation 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 SI unit of radiation exposure is the coulomb per kilogram (C/kg). (See
section 33.1-10-01-14 units of exposure, dose, and activity for the special unit equivalent
"roentgen" (R).)
104. "Radiation exposure rate" means the radiation exposure per unit of time, such as R/min,
mR/h, etc.
105. "Radiation machine" means any device capable of producing radiation except those devices
with radioactive material as the only source of radiation.

106. "Radiation therapy simulation system" means a radiographic, fluoroscopic, or computed
tomography x-ray system intended for localizing the volume to be exposed during radiation
therapy and confirming the position and size of the therapeutic irradiation field.
107. "Radiograph" means an image receptor on which the image is created directly or indirectly by
an x-ray pattern and results in a permanent record.
108. "Radiographic imaging system" means any system whereby a permanent or temporary image
is recorded on an image receptor by the action of ionizing radiation.
109. "Radiological physicist" means an individual who:
a. Is certified by the American board of radiology in therapeutic radiological physics,
radiological physics, or x-ray and gamma-ray physics;
b. Has a bachelor's degree in one of the physical sciences or engineering and three year's
full-time experience working in therapeutic or diagnostic radiological physics under the
direction of a physicist certified by the American board of radiology. The work duties must
include duties involving the calibration and spot checks of a medical accelerator or a
sealed source teletherapy unit; or
c. Has a master's or a doctor's degree in physics, biophysics, radiological physics, health
physics, or engineering; has had one year's full-time training in therapeutic or diagnostic
radiological physics; and has had one year's full-time work experience in a radiotherapy
facility where the individual's duties involve calibration and spot checks of a medical
accelerator or a sealed source teletherapy unit.
110. "Rating" means the operating limits as specified by the component manufacturer.
111. "Recording" means producing a permanent form of an image resulting from x-ray photons.
112. "Registrant" means any person, group, or facility who is registered with the department and is
legally obligated to register with the department pursuant to North Dakota Century Code
chapter 23.1-02.
113. "Roentgen" or "(R)" means the special unit of exposure. One roentgen equals two hundred
fifty-eight millionth of a coulomb per kilograph of air.
114. "Scattered radiation" means radiation that, during passage through matter, has been deviated
in direction (see "direct scattered radiation").
115. "Secondary dose monitoring system" means a system which will terminate irradiation in the
event of failure of the primary dose monitoring system.
116. "Secondary protective barrier" (see "protective barrier").
117. "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.
118. "SI" means the abbreviation for the international system of units.
119. "SID" has the same meaning as "source-image receptor distance".
120. "Source" means the location or material, or both, from which the radiation emanates.
121. "Source-image receptor distance" means the distance from the source to the center of the
input surface of the image receptor.

122. "Spot check" means a procedure which is performed to assure that a previous calibration
continues to be valid.
123. "Spot film" means a radiograph which is made during a fluoroscopic examination to
permanently record conditions which exist during that fluoroscopic procedure.
124. "Spot-film device" means a device intended to transport or position a radiographic image
receptor between the x-ray source and fluoroscopic image receptor. It includes a device
intended to hold a cassette over the input end of an image intensifier for the purpose of
making a radiograph.
125. "Stationary x-ray equipment" (see "x-ray equipment").
126. "Stray radiation" means the sum of leakage and scattered radiation.
127. "Survey" means an evaluation of the radiological conditions which may include tests, physical
examinations, and measurements of levels of radiation.
128. "Technique factors" means the conditions of operation. They are specified as follows:
a. For capacitor energy storage equipment, peak tube potential in kilovolts and quantity of
charge in milliampere second.
b. For field emission equipment rated for pulsed operation, peak tube potential in kilovolts
and number of x-ray pulses.
c. For CT x-ray systems designed for pulsed operation, peak tube potential in kilovolts,
scan time in seconds, and either tube current in milliampere, x-ray pulse width in
seconds, and the number of x-ray pulses per scan, or the product of tube current, x-ray
pulse width, and the number of x-ray pulses in milliampere second.
d. For CT x-ray systems not designed for pulsed operation, peak tube potential in kilovolts,
and either tube current in milliampere and scan time in seconds, or the product of tube
current and exposure time in milliampere second and the scan time when the scan time
and exposure time are equivalent.
e. For all other equipment, peak tube potential in kilovolt and either tube current in
milliampere and exposure time in seconds, or the product of tube current and exposure
time in milliampere second.
129. "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.
130. "Tomogram" means the depiction of x-ray attenuation properties of a section through the body.
131. "Traceable to a national standard" means that a quantity or a measurement has been
compared to a national standard directly or indirectly through one or more intermediate steps
and that all comparisons have been documented.
132. "Tube" means an x-ray tube, unless otherwise specified.
133. "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.
134. "Tube rating chart" means the set of curves which specify the rated limits of operation of the
tube in terms of the technique factors.

135. "Useful beam" means the radiation emanating from the tube housing port or the radiation head
and passing through the aperture of the beam limiting device when the exposure controls are
in a mode to cause the system to produce radiation.
136. "Variable-aperture beam-limiting device" means a beam-limiting device which has capacity for
stepless adjustment of the x-ray field size at a given source-image receptor distance.
137. "Visible area" means that portion of the input surface of the image receptor over which
incident x-ray photons are producing a visible image.
138. "Wedge filter" means an added filter effecting continuous progressive attenuation on all or part
of the useful beam.
139. "Whole body" means for purposes of external exposure, head, trunk including male gonads,
arms above the elbows, or legs below the knees.
140. "X-ray exposure control" means a device, switch, button, or other similar means by which the
operator initiates or terminates, or both, the radiation exposure. It may include equipment such
as timers, phototimers, automatic brightness stabilizers, and similar devices.
141. "X-ray equipment" means an x-ray system, subsystem, or component thereof. Types of x-ray
equipment are as follows:
a. "Hand-held dental x-ray equipment" means any dental x-ray equipment which is
designated to be physically held during x-ray exposure.
b. "Mobile x-ray equipment" means x-ray equipment mounted on a permanent base with
wheels or casters for moving while completely assembled.
c. "Portable x-ray equipment" means x-ray equipment designed to be hand-carried.
d. "Stationary x-ray equipment" means x-ray equipment which is installed in a fixed location.
142. "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 radiation exposure rate is one-fourth of the maximum in the intersection.
143. "X-ray high-voltage generator" means a device which transforms electrical energy from the
potential supplied by the x-ray control to the tube operating potential. The device may also
include means for transforming alternating current to direct current, filament transformers for
the x-ray tube, high-voltage switches, electrical protective devices, and other appropriate
elements.
144. "X-ray system" means an assemblage of components for the controlled production of x-rays. It
includes minimally an x-ray high-voltage generator, an x-ray control, a tube housing assembly,
a beam-limiting device, and the necessary supporting structures. Additional components which
function with the system are considered integral parts of the system.
145. "X-ray tube" means any electron tube which is designed for the conversion of electrical energy
into x-ray energy.
History: Effective January 1, 2019.
General Authority: NDCC 23.1-03-04; S.L. 2017, ch. 199, § 1
Law Implemented: NDCC 23.1-03-03, 23.1-03-04; S.L. 2017, ch. 199, § 18
### § 33.1-10-06-03. General requirements.

1. Administrative controls.

a. Registrant. The registrant shall be responsible for directing the operation of the x-ray
systems which have been registered with the department. The registrant or the
registrant's agent shall assure that the requirements are met in the operation of the x-ray
system.
(1) An x-ray system which does not meet the requirements of this article shall not be
operated for diagnostic or therapeutic purposes.
(2) All individuals, except those listed in part 1 of appendix G, prior to operating the
x-ray systems shall be adequately instructed in the safe operating procedures and
be competent in the safe use of the equipment commensurate with the size, scope,
and nature of the service as outlined in appendix F. In addition, all individuals shall
meet the specific requirements as outlined in subparagraph a or b. The department
may use interview, observation, or testing to determine compliance. Records must
be maintained by the registrant to demonstrate compliance with this paragraph.
(a) General diagnostic operators are not limited in scope of practice. Obtaining
general diagnostic operator status will consist of one of the following:
[1] Obtain board eligibility or board certification with the American registry of
radiologic technologists (ARRT);
[2] Obtain board eligibility or board certification with the American chiropractic
registry of radiologic technologists (ACRRT); and only perform x-ray
examinations for chiropractic services;
[3] Receive department approval, through individual consideration, by
demonstration of an acceptable level of education and clinical training; or
[4] Demonstrate current enrollment in an educational program accredited by
a process acceptable to the department, and provide documentation of
competency in all routine radiographic procedures and specialty views.
(b) Limited x-ray machine operators are limited in scope of practice to only those
procedures listed in appendix I, except as allowed in subparagraph c. Limited
x-ray machine operators must meet the prerequisite qualifications, receive
training, and demonstrate competence as follows:
[1] Limited x-ray machine operators shall have successfully completed the
course of training required by one of the allied health professions listed in
part 2 of appendix G;
[2] Complete at least eighty hours of didactic instruction at a single training
program providing didactic instruction in accordance with part 1 of
appendix H;
[3] Complete the three hour self-study course designed by the department of
environmental quality; and
[4] Complete the clinical experience requirements in part 2 of appendix H.
(c) Limited x-ray machine operators may only conduct diagnostic x-ray
examinations outside the scope of practice of appendix I in accordance with
the following:

[1] When it is determined to be an emergency and ordered by individuals
listed in part 3 of appendix G. The individual requesting the procedures
must comply with subitems a, b, and c.
[a] The requesting individual must provide a written order specifying
what types of diagnostic x-ray examinations outside the scope of
procedures listed in appendix I are requested. The order shall
contain an explanation of the emergency nature or medical reason
for the order.
[b] The requesting individual must provide direct supervision during the
time the x-ray image is obtained.
[c] The facility must keep records of all emergency x-ray procedures
ordered under this subparagraph.
[2] When a practice requires a specific view or examination outside the
scope of practice listed in appendix I to be conducted on a routine basis,
and the facility has only limited x-ray machine operators, application may
be made to the department requesting approval for a limited x-ray
machine operator to perform the procedure. This allowance shall be
limited to the facility, the specific individual, and the procedure requested.
After an allowance has been granted, reapplication and reauthorization
are not necessary for the same procedure. The application for allowance
should include the following:
[a] Documentation which demonstrates the need for the specific view;
[b] Documentation on forms supplied by the department indicating that
each individual for which the request is made has demonstrated
competence in the procedure; and
[c] Proof of additional didactic instruction or completion of examination
as deemed necessary by the department for each individual.
[3] When it is not a computed tomography examination.
(d) Limited x-ray machine operator implementation period. Individuals who begin taking
x-rays after one year from March 1, 2003, will have to meet all of the requirements
of this paragraph before operating the x-ray system.
(3) General diagnostic and limited diagnostic x-ray operators shall maintain continuing
education units as outlined in appendix K.
(4) A chart shall be provided in the vicinity of the diagnostic x-ray system's control
panel, which specifies for all examinations performed with that system the following
information:
(a) Patient's body part and anatomical size or body thickness, or age (for
pediatrics), versus technique factors to be utilized.
(b) Type and size of the film or film screen combination to be used.
(c) Type and focal distance of the grid to be used, if any.
(d) Source-image receptor distance to be used (except for dental intraoral
radiography).

(e) Type and location of placement of gonad shielding to be used.
(f) For mammography, indication of kVp/target/filter combination.
(5) The registrant of a facility shall create and make available to x-ray operators written
safety procedures, including patient holding restrictions and any restrictions of the
operating technique required for the safe operation of the particular x-ray system.
The operator shall be able to demonstrate familiarity with these procedures.
(6) Except for human patients who cannot be moved out of the room, only the staff and
ancillary personnel or other persons required for the medical procedure or training
shall be in the room during the radiographic exposure. Other than the patient being
examined:
(a) All individuals shall be positioned such that no part of the body will be struck by
the useful beam unless protected by not less than five-tenths millimeter lead
equivalent material.
(b) The x-ray operator, other staff, ancillary personnel, and other persons required
for the x-ray procedure shall be protected from the direct scatter radiation by
protective aprons or whole body protective barriers of not less than twenty-five
one-hundredths millimeter lead equivalent material.
(c) Human patients who cannot be removed from the room shall be protected from
the direct scatter radiation by whole body protective barriers of not less than
twenty-five one-hundredths millimeter lead equivalent material or shall be so
positioned that the nearest portion of the body is at least two meters from both
the tube head and the nearest edge of the image receptor.
(7) Gonad shielding of not less than five-tenths millimeter lead equivalent material must
be used for human patients who have not passed the reproductive age during
radiographic procedures in which the gonads are in the useful beam, except for
cases in which this would interfere with the diagnostic procedure.
(8) Individuals may not be exposed to the useful beam except for healing arts purposes
and when such exposure has been authorized by a licensed practitioner of the
healing arts. This provision specifically prohibits deliberate exposure for the
following purposes:
(a) Exposure of an individual for training, demonstration, or other non-healing-arts
purposes.
(b) Exposure of an individual for the purpose of healing arts screening except as
authorized by paragraph 12.
(9) When a patient or film must be provided with auxiliary support during a radiation
exposure:
(a) Mechanical holding devices shall be used when the technique permits. The
safety rules, required by this section shall list individual projections where
holding devices cannot be utilized.
(b) Written safety procedures, as required by paragraph 4, shall indicate the
requirements for selecting a holder and the procedure the holder shall follow.
(c) The human holder shall be instructed in personal radiation safety and
protected as required by paragraph 6.

(d) No individual shall be used routinely to hold film or patients.
(e) In those cases where the patient must hold the film, except during intraoral
examinations, any portion of the body other than the area of clinical interest
struck by the useful beam shall be protected by not less than five-tenths
millimeter lead equivalent material.
(f) A record shall be made of the examination and shall include the name of the
human holder, date of the examination, number of exposures, and technique
factors utilized for the exposure.
(g) Each facility shall have leaded aprons and gloves available in sufficient
numbers to provide protection to all personnel who are involved with x-ray
operations and who are otherwise not shielded.
(10) Procedures and auxiliary equipment designed to minimize patient and personnel
exposure commensurate with the needed diagnostic information shall be utilized.
This is interpreted to include:
(a) The speed of film and screen combinations shall be the fastest speed
consistent with the diagnostic objective of the examinations. Film cassettes
without intensifying screens shall not be used for any routine diagnostic
radiological imaging, with the exception of veterinary radiography, therapeutic
portal imaging, and standard film packets for intraoral use in dental
radiography.
(b) The radiation exposure to the patient shall be the minimum exposure required
to produce images of good diagnostic quality.
(c) Proper film handling and processing procedures. Each installation using a
radiographic x-ray system and using analog image receptors (e.g.,
radiographic film) shall have available suitable equipment for handling and
processing radiographic film in accordance with appendix D.
(d) Portable or mobile equipment shall be used only for examinations where it is
impractical to transfer the patients to a stationary x-ray installation.
(e) X-ray systems subject to section 33.1-10-06-06 shall not be utilized in
procedures where the source to patient distance is less than thirty centimeters,
except for veterinary systems.
(f) If grids are used between the patient and the image receptor to decrease
scatter to the film and improve contrast, the grid shall:
[1] Be positioned properly, for example, tube side facing the right direction
and grid centered to the central ray; and
[2] If the grid is of the focused type, be of the proper focal distance for the
source-image distances being used.
(11) All individuals who are associated with the operation of an x-ray system are subject
to the requirements of section 33.1-10-04.2-01 [10 CFR 20.1201, 20.1207, and
20.1208]. In addition:
(a) When protective clothing or devices are worn on portions of the body and a
monitoring device is required, at least one such monitoring device shall be
utilized as follows:

[1] When an apron is worn, the monitoring device shall be worn at the collar
outside of the apron.
[2] The dose to the whole body based on the maximum dose attributed to the
most critical organ shall be recorded in the reports required by section
record is made of the data, each dose shall be identified with the area
where the device was worn on the body.
(b) Exposure of a personnel monitoring device to deceptively indicate a dose
delivered to an individual is prohibited.
(12) Healing arts screening. Any person proposing to conduct a healing arts screening
program shall not initiate such a program without prior approval of the department.
When requesting such approval, that person shall submit the information outlined in
appendix E. If any information submitted to the department becomes invalid or
outdated, the department shall be immediately notified.
b. Information and maintenance record and associated information. The registrant shall
maintain the following information for each x-ray system for inspection by the
department:
(1) Maximum rating of technique factors.
(2) Model and serial numbers of all major components and user's manuals for those
components.
(3) Aluminum equivalent filtration of the useful beam, including any routine variation.
(4) Tube rating charts and cooling curves.
(5) Records of surveys, calibrations, maintenance, and modifications performed on the
x-ray system with the names of persons who performed such services.
(6) A scale drawing of the room in which a stationary x-ray system is located with such
drawing indicating the use of areas adjacent to the room and an estimation of the
extent of occupancy by an individual in such areas. In addition, the drawing shall
include:
(a) The results of a survey for radiation levels present at the operator's position
and at pertinent points outside the room at specified test conditions; or
(b) The type and thickness of materials, or lead equivalency, of each protective
barrier.
(7) A copy of all correspondence with this department regarding that x-ray system.
c. X-ray log.
(1) Except for veterinary facilities, each facility shall maintain an x-ray log containing the
patient's name, the type of examinations, the dates those examinations were
performed, and the name of the x-ray operator. When the patient or film must be
provided with human auxiliary support, the name of the human holder shall be
recorded.
(2) Veterinary facilities shall maintain an x-ray utilization log indicating the type of
examinations, the date of the examinations and if the patient or film was provided
with human auxiliary support, the name of the human holder.

2. Plan review.
a. Prior to construction, the floor plans, shielding specifications, and equipment
arrangement of all new installations, or modifications of existing installations, utilizing
ionizing radiation machines shall be submitted to the department for review and approval.
The required information is denoted in appendices A, B, and C.
b. The department may require the applicant to utilize the services of a qualified expert to
determine the shielding requirements prior to the plan review and approval.
c. The approval of such plans shall not preclude the requirement of additional modifications
should a subsequent analysis of operating conditions indicate the possibility of an
individual receiving a dose in excess of the limits prescribed in section 33.1-10-04.2-01
[10 CFR 20.1201, 20.1207, 20.1208, and 20.1301].
History: Effective January 1, 2019.
General Authority: NDCC 23.1-03-04; S.L. 2017, ch. 199, § 1
Law Implemented: NDCC 23.1-03-03, 23.1-03-04; S.L. 2017, ch. 199, § 18
### § 33.1-10-06-04. General requirements for all diagnostic x-ray systems.

In addition to other requirements of this chapter, all diagnostic x-ray systems shall meet the
following requirements:
1. Warning label. The control panel containing the main power switch shall bear the warning
statement, legible and accessible to view: "WARNING: This x-ray unit may be dangerous to
patient and operator unless safe exposure factors and operating instructions are observed."
2. Battery charge indicator. On battery-powered x-ray generators, visual means shall be
provided on the control panel to indicate whether the battery is in a state of charge adequate
for proper operation.
3. Leakage radiation from the diagnostic source assembly. The leakage radiation from the
diagnostic source assembly measured at a distance of one meter in any direction from the
source shall not exceed one hundred milliroentgens in one hour when the x-ray tube is
operated at its leakage technique factors. Compliance shall be determined by measurements
averaged over an area of one hundred square centimeters with no linear dimension greater
than twenty centimeters.
4. Radiation from components other than the diagnostic source assembly. The radiation
emitted by a component other than the diagnostic source assembly shall not exceed
two milliroentgens in one hour at five centimeters from any accessible surface of the
component when it is operated in an assembled x-ray system under any conditions for which it
was designed. Compliance shall be determined by measurements averaged over an area of
one hundred square centimeters with no linear dimension greater than twenty centimeters.
5. Beam quality.
a. Half-value layer.
(1) The half-value layer (HVL) of the useful beam for a given x-ray tube potential shall
not be less than the values shown in table I. If it is necessary to determine such half
value layer at an x-ray tube potential which is not listed in table I, linear interpolation
or extrapolation may be made.

Half-Value Layer in Millimeters Aluminum
Dental Intraoral
Manufactured Diagnostic Diagnostic
Design Before Aug. 1, X-Ray Systems X-Ray Systems
Operating Measured 1974, and on Manufactured Manufactured
Range Potential or After Dec. 1, Prior to on or After
(Kilovolts Peak) (Kilovolts Peak) 1980 June 10, 2006 June 10, 2006
Below 51 30 N/A 0.3 0.3
40 N/A 0.4 0.4
50 1.5 0.5 0.5
51 to 70 51 1.5 1.2 1.3
60 1.5 1.3 1.5
70 1.5 1.5 1.8
Above 70 71 2.1 2.1 2.5
80 2.3 2.3 2.9
90 2.5 2.5 3.2
100 2.7 2.7 3.6
110 3.0 3.0 3.9
120 3.2 3.2 4.3
130 3.5 3.5 4.7
140 3.8 3.8 5.0
150 4.1 4.1 5.4
(2) For capacitor energy storage equipment, compliance with the requirements of this
subsection shall be determined with the system fully charged and a setting of
ten mAs for each exposure.
(3) The required minimal aluminum equivalent filtration shall include the filtration
contributed by all materials which are permanently present between the source and
the patient.
(4) For mammography systems with molybdenum filter and molybdenum target,
measured half-value layer (HVL) with compression device in the x-ray beam shall
be greater than or equal to the kilovolts peak (kVp) divided by one hundred,
millimeters aluminum and less than or equal to the kilovolts peak (kVp) divided by
one hundred plus one-tenth millimeter aluminum.
HVL > (kVp/100) mmAl and < (kVp/100) + 0.1 mmAl
b. Filtration controls. For x-ray systems which have variable kilovolts peak and variable
filtration for the useful beam, a device shall link the kilovolts peak selector with the filters
and shall prevent an exposure unless the minimum amount of filtration required by
paragraph 1 of subdivision a is in the useful beam for the given kilovolts peak which has
been selected.

6. Multiple tubes. Where two or more radiographic tubes are controlled by one exposure switch,
the tube or tubes which have been selected shall be clearly indicated prior to initiation of the
exposure. This indication shall be both on the x-ray control panel and at or near the tube
housing assembly which has been selected.
7. Mechanical support of tube head. The tube housing assembly supports shall be adjusted
such that the tube housing assembly will remain stable during an exposure unless tube
housing movement is a designed function of the x-ray system.
8. Technique indicators.
a. The technique factors to be used during an exposure shall be indicated before the
exposure begins, except when automatic exposure controls are used, in which case the
technique factors which are set prior to the exposure shall be indicated.
b. The requirements of subdivision a may be met by permanent markings on equipment
having fixed technique factors. Indication of technique factors shall be visible from the
operator's position except in the case of spot films made by the fluoroscopist.
9. Maintaining compliance. Diagnostic x-ray systems and their associated components used
on humans and certified pursuant to the federal x-ray equipment performance standard
(21 CFR part 1020) shall be maintained in compliance with applicable requirements of that
standard.
10. Locks. All position locking, holding, and centering devices on x-ray system components and
systems shall function as intended.
11. Structural shielding requirements (see appendix C).
History: Effective January 1, 2019.
General Authority: NDCC 23.1-03-04; S.L. 2017, ch. 199, § 1
Law Implemented: NDCC 23.1-03-03, 23.1-03-04; S.L. 2017, ch. 199, § 18
### § 33.1-10-06-05. Fluoroscopic x-ray systems.

All fluoroscopic x-ray systems shall be image-intensified and meet the following requirements:
1. Limitation of useful beam.
a. Primary barrier.
(1) The fluoroscopic imaging assembly shall be provided with a primary protective
barrier which intercepts the entire cross-section of the useful beam at any
source-image receptor distance (SID).
(2) The x-ray tube used for fluoroscopy shall not produce x-rays unless the barrier is in
position to intercept the entire useful beam.
b. X-ray field.
(1) For certified fluoroscopic systems with or without a spot-film device, neither the
length nor the width of the x-ray field in the plane of the image receptor shall exceed
that of the visible area of the image receptor by more than three percent of the
source-image receptor distance. The sum of the excess length and the excess width
shall be no greater than four percent of the source-image receptor distance.
(2) For uncertified fluoroscopic systems with a spot-film device, the x-ray beam with the
shutters fully opened (during fluoroscopy or spot filming) shall be no larger than the

largest spot-film size for which the device is designed. Measurements shall be made
at the maximum source-image distance available but at no less than twenty
centimeters tabletop to the film plane distance.
(3) For uncertified fluoroscopic systems without a spot-film device, the requirements of
paragraph 1 apply.
(4) Other requirements for fluoroscopic beam limitation:
(a) Means shall be provided to permit further limitation of the field. Beam-limiting
devices manufactured after May 22, 1979, and incorporated in equipment with
a variable source-image receptor distance and/or a visible area of greater than
three hundred square centimeters shall be provided with means for stepless
adjustment of the x-ray field.
(b) All equipment with a fixed source-image receptor distance and a visible area of
three hundred square centimeters or less shall be provided with either stepless
adjustment of the x-ray field or with means to further limit the x-ray field size at
the plane of the image receptor to one hundred twenty-five square centimeters
or less. Stepless adjustment shall, at the greatest source-image receptor
distance, provide continuous field sizes from the maximum obtainable to a field
size of five centimeters by five centimeters or less.
(c) For equipment manufactured after February 25, 1978, when the angle between
the image receptor and beam axis is variable, means shall be provided to
indicate when the axis of the x-ray beam is perpendicular to the plane of the
image receptor.
(d) Compliance shall be determined with the beam axis indicated to be
perpendicular to the plane of the image receptor. For noncircular x-ray fields
used with circular image receptors, the error in alignment shall be determined
along the length and width dimensions of the x-ray field which pass through the
center of the visible area of the image receptor.
(5) Spot-film devices shall meet the following additional requirements:
(a) Means shall be provided between the source and the patient for adjustment of
the x-ray field size in the plane of the film to the size of that portion of the film
which has been selected on the spot-film selector. Such adjustment shall be
automatically accomplished except when the x-ray field size in the plane of the
film is smaller than that of the selected portion of the film. For spot-film devices
manufactured after June 21, 1979, if the x-ray field size is less than the size of
the selected portion of the film, the means for adjustment of the field size shall
be only at the operator's option.
(b) Neither the length nor the width of the x-ray field in the plane of the image
receptor shall differ from the corresponding dimensions of the selected portion
of the image receptor by more than three percent of the source-image receptor
distance when adjusted for full coverage of the selected portion of the image
receptor. The sum, without regard to sign, of the length and width differences
shall not exceed four percent of the source-image receptor distance.
(c) It shall be possible to adjust the x-ray field size in the plane of the film to a size
smaller than the selected portion of the film. The minimum field size at the
greatest source-image receptor distance shall be equal to, or less than, five
centimeters by five centimeters.

(d) The center of the x-ray field in the plane of the film shall be aligned with the
center of the selected portion of the film to within two percent of the
source-image receptor distance.
(e) On spot-film devices manufactured after February 25, 1978, if the angle
between the plane of the image receptor and beam axis is variable, means
shall be provided to indicate when the axis of the x-ray beam is perpendicular
to the plane of the image receptor, and compliance shall be determined with
the beam axis indicated to be perpendicular to the plane of the image receptor.
(6) If a means exists to override any of the automatic x-ray field size adjustments
required in subdivision b of subsection 1 that means:
(a) Must be designed for use only in the event of system failure.
(b) Must incorporate a signal visible at the fluoroscopist's position which will
indicate whenever the automatic field size adjustment is overridden.
(c) Must be clearly and durably labeled as follows:
2. Activation of the fluoroscopic tube. X-ray production in the fluoroscopic mode shall be
controlled by a device which requires continuous pressure by the fluoroscopist for the entire
time of any exposure. When recording serial fluoroscopic images, the fluoroscopist shall be
able to terminate the x-ray exposure or exposures at any time, but means may be provided to
permit completion of any single exposure of the series in process.
3. Radiation exposure rate limits.
a. Entrance exposure rate allowable limits.
(1) Fluoroscopic equipment which is provided with automatic exposure rate control:
(a) The radiation exposure measured at the point where the center of the useful
beam enters the patient shall not exceed two and fifty-eight hundredths
millicoulomb per kilogram [10 roentgens] per minute, except during recording
of fluoroscopic images or when provided with optional high-level control.
(b) When provided with optional high-level control, the equipment shall not be
operable at any combination of tube potential and current which will result in a
radiation exposure rate in excess of one and twenty-nine hundredths
millicoulomb per kilogram [5 roentgens] per minute at the point where the
center of the useful beam enters the patient unless the high-level control is
activated.
[1] When the high-level control is activated, the equipment shall not be
operable at any combination of tube potential and current that will result in
an exposure rate in excess of five and sixteen hundredths millicoulomb
per kilogram [20 roentgens] per minute at the point where the center of
the useful beam enters the patient.
[2] Special means of activation of high-level controls shall be required. The
high-level control only shall be operable when continuous manual
activation is provided by the operator.

[3] A continuous signal audible to the fluoroscopist shall indicate that the
high-level control is being employed.
(2) Fluoroscopic equipment which is not provided with automatic exposure rate control:
(a) The radiation exposure measured at the point where the center of the useful
beam enters the patient shall not exceed one and twenty-nine hundredths
millicoulomb per kilogram [5 roentgens] per minute, except during recording of
fluoroscopic images or when provided with an optional high-level control and
the high-level control is activated.
[1] When the high-level control is activated, the equipment shall not be
operable at any combination of tube potential and current that will result in
an exposure rate in excess of five and sixteen hundredths millicoulomb
per kilogram [20 roentgens] per minute at the point where the center of
the useful beam enters the patient.
[2] Special means of activation of high-level controls shall be required. The
high-level control shall only be operable when continuous manual
activation is provided by the operator.
[3] A continuous signal audible to the fluoroscopist shall indicate that the
high-level control is being employed.
(3) Compliance with the requirements of subsection 3 of this section shall be
determined as follows:
(a) Movable grids and compression devices shall be removed from the useful
beam during the measurement.
(b) If the source is below the table, the radiation exposure rate shall be measured
one centimeter above the tabletop or cradle.
(c) If the source is above the table, the radiation exposure rate shall be measured
at thirty centimeters above the tabletop with the end of the beam-limiting
device or spacer positioned as closely as possible to the point of
measurement.
(d) In a C arm type of fluoroscope, both stationary and mobile units shall meet the
entrance exposure rate limits specified in paragraphs 1, 2, and 3 of
subdivision a of subsection 3, shall be measured thirty centimeters from the
input surface of the fluoroscopic imaging assembly with the source positioned
at any available source-image receptor distance provided that the end of the
spacer assembly or beam-limiting device is not closer than thirty centimeters
from the input surface of the fluoroscopic imaging assembly.
(e) In a lateral type of fluoroscope, the exposure rate shall be measured at a point
fifteen centimeters from the centerline of the x-ray table and in the direction of
the x-ray source with the end of the beam-limiting device or spacer positioned
as closely as possible to the point of measurement. If the tabletop is movable,
it shall be positioned as closely as possible to the lateral x-ray source, with the
end of the beam-limiting device or spacer no closer than fifteen centimeters to
the centerline of the x-ray table.
(4) Periodic measurement of entrance exposure rate shall be performed by a qualified
expert for both typical and maximum values as follows:

(a) Such measurements shall be made annually or after any maintenance of the
system which might affect the radiation exposure rate.
(b) Results of these measurements shall be posted where any fluoroscopist may
have ready access to such results while using the fluoroscope and in the
record required in paragraph 5 of subdivision b of subsection 1 of section
### § 33.1-10-06-03. Results of the measurements shall include the roentgen per

minute, as well as the technique factors used to determine such results. The
name of the person performing the measurements and the date the
measurements were performed shall be included in the results.
(c) Conditions of periodic measurements of typical entrance exposure rate are as
follows:
[1] The measurement shall be made under the conditions that satisfy the
requirements of paragraph 4.
[2] The kilovolts peak, mA, and other selectable parameters shall be the
settings typical of clinical use on a twenty-three centimeters thick
abdominal patient.
[3] The x-ray systems that incorporate automatic exposure control shall have
sufficient material placed in the useful beam to produce a milliamperage
or kilovoltage, or both, to satisfy the conditions of item 2.
[4] X-ray systems that do not incorporate an automatic exposure control shall
utilize a milliamperage typical of clinical use of the x-ray system. Materials
should be placed in the useful beam when conducting these periodic
measurements to protect the imaging system.
(d) Conditions of periodic measurements of maximum entrance exposure rate are
as follows:
[1] The measurement shall be made under the conditions that satisfy the
requirements of paragraph 3.
[2] The kVp, mA, and other selectable parameters shall be the maximum
selectable parameters of clinical use of the x-ray system.
[3] The x-ray systems that incorporate automatic exposure control shall have
sufficient material placed in the useful beam to produce a kVp, mA, and
other selectable parameters to satisfy the conditions of item 2.
[4] X-ray systems that do not incorporate an automatic exposure control shall
utilize the maximum kVp, mA, and other selectable parameters of clinical
use of the x-ray system. Materials should be placed in the useful beam
when conducting these periodic measurements to protect the imaging
system.
4. Barrier transmitted radiation rate limits.
a. The radiation exposure rate due to transmission through the primary protective barrier
with the attenuation block in the useful beam, combined with radiation from the image
intensifier, shall not exceed five hundred sixteen thousandths microcoulomb per kilogram
[2 milliroentgens] per hour at ten centimeters from any accessible surface of the
fluoroscopic imaging assembly beyond the plane of the image receptor for each roentgen
(C/kg) per minute of entrance exposure rate.

b. Measuring compliance of barrier transmission.
(1) The radiation exposure rate due to transmission through the primary protective
barrier combined with radiation from the image intensifier shall be determined by
measurements averaged over an area of one hundred square centimeters with no
linear dimension greater than twenty centimeters.
(2) If the source is below the tabletop, the measurement shall be made with the input
surface of the fluoroscopic imaging assembly positioned thirty centimeters above
the tabletop.
(3) If the source is above the tabletop and the source-image receptor distance is
variable, the measurement shall be made with the end of the beam-limiting device
or spacer as close to the tabletop as it can be placed, provided that it shall not be
closer than thirty centimeters.
(4) Movable grids and compression devices shall be removed from the useful beam
during the measurement.
5. Indication of potential and current. During fluoroscopy and cinefluorography, the kilovolt
and the milliampere shall be continuously indicated.
6. Indication of air kerma rate and cumulative air kerma. Machines manufactured on or after
June 10, 2006, shall provide displays of values of air kerma rate and cumulative air kerma and
shall be viewable from the x-ray operator position.
a. When the x-ray tube is activated and the number of images produced per unit time is
greater than six images per second, the air kerma rate in mGy/minute shall be
continuously displayed and updated at least once every second.
b. The cumulative air kerma in units of mGy shall be displayed either within five seconds of
termination of an exposure or displayed continuously and updated at least once every
five seconds.
c. The display of the air kerma rate shall be clearly distinguishable from the display of the
cumulative air kerma.
d. The air kerma rate and cumulative air kerma shall represent the value of conditions of
free-in-air irradiation at one of the following reference locations specified according to the
type of fluoroscope.
(1) For fluoroscopies with x-ray source below the x-ray table, x-ray source above the
table, or of lateral type, the reference locations shall be the respective locations
specified in subparagraphs b, c, and e of paragraph 3 of subdivision a of
subsection 3 for measuring compliance with air kerma rate limits.
(2) For C-arm fluoroscopies, the reference location shall be fifteen centimeters from the
isocenter toward the x-ray source along the beam axis. Alternatively, the reference
location shall be at a point specified by the manufacturer to represent the location of
the intersection of the x-ray beam with the patient's skin.
e. Means shall be provided to reset to zero the display of cumulative air kerma prior to the
commencement of a new examination or procedure.
f. The displayed air kerma rate and cumulative air kerma shall not deviate from the actual
values by more than plus or minus thirty-five percent over the range of six mGy/minute
(0.6 R/min) and one hundred mGy (10 R) to the maximum indication of air kerma rate

and cumulative air kerma, respectively. Compliance shall be determined with an
irradiation time greater than three seconds.
7. Source skin distance. The source to skin distance shall not be less than:
a. Thirty eight centimeters on stationary fluoroscopes installed after August 1, 1974.
b. Thirty-five and one-half centimeters on stationary fluoroscopes which were in operation
prior to August 1, 1974.
c. Thirty centimeters on all mobile fluoroscopes.
d. Twenty centimeters for all mobile fluoroscopes used for specific surgical applications.
8. Fluoroscopic timer.
a. Means shall be provided to preset the cumulative on-time of the fluoroscopic tube. The
maximum cumulative time of the timing device shall not exceed five minutes without
resetting.
b. A signal audible to the fluoroscopist shall indicate the completion of any preset
cumulative on-time. Such signal shall continue to sound while x-rays are produced until
the timing device is reset.
9. Control of scattered radiation.
a. Fluoroscopic table designs when combined with procedures utilized shall be such that no
unprotected part of any staff or ancillary individual's body shall be exposed to
unattenuated scattered radiation which originates from under the table. The attenuation
required shall be not less than twenty-five one hundredths millimeter lead equivalent.
b. Equipment configuration when combined with procedures shall be such that no portion of
any staff or ancillary individual's body, except the extremities, shall be exposed to the
unattenuated scattered radiation emanating from above the tabletop unless that
individual:
(1) Is at least one hundred twenty centimeters from the center of the useful beam; or
(2) The radiation has passed through not less than twenty-five one hundredths
millimeter lead equivalent material, including drapes, bucky-slot cover-sliding or
folding panel, or self supporting curtains, in addition to any lead equivalency
provided by the protective apron referred to in paragraph 5 of subdivision a of
subsection 1 of section 33.1-10-06-03.
c. The department may grant exceptions to subdivision b of this subsection in some special
procedures where a sterile field will not permit the use of the normal protective barriers.
Where the use of prefitted sterilized covers for the barriers is practical, the department
shall not permit such exception.
10. Spot-film exposure reproducibility. Fluoroscopic systems equipped with spot-film mode
shall meet the exposure reproducibility requirements of subsection 5 of section 33.1-10-06-06
when operating in the spot-film mode.
11. Radiation therapy simulation system. Radiation therapy simulation systems shall be
exempt from all the requirements of subsections 1, 3, 4, and 8 provided that:

a. Such systems are designed and used in such a manner that no individual other than the
patient is in the x-ray room during periods of time when the system is producing x-rays;
and
b. Such systems as do not meet the requirements of subsection 7 are provided with a
means of indicating the cumulative time that an individual patient has been exposed to
x-rays. Procedures shall require in such cases that the timer be reset between
examinations.
12. Structural shielding requirements (see appendix E).
History: Effective January 1, 2019.
General Authority: NDCC 23.1-03-04; S.L. 2017, ch. 199, § 1
Law Implemented: NDCC 23.1-03-03, 23.1-03-04; S.L. 2017, ch. 199, § 18
### § 33.1-10-06-06. Radiographic systems other than fluroscopic, dental intraoral, bone

densitometry, or computed tomography x-ray systems.
1. Beam limitation requirements for systems without positive beam limitation including
portable x-ray systems. The useful beam shall be limited to the area of clinical interest.
a. General purpose stationary and mobile x-ray systems including veterinary systems (other
than portable) installed after January 1, 1998.
(1) There shall be provided a means for independent length and width stepless
adjustment to the size of the x-ray field.
(2) Means shall be provided for visually defining the perimeter of the x-ray field. The
total misalignment of the edges of the visually defined field with the respective
edges of the x-ray field along either the length or width of the visually defined field
shall not exceed two percent of the distance from the source to the center of the
visually defined field when the surface upon which it appears is perpendicular to the
axis of the x-ray beam.
(3) The department may grant an exemption to paragraphs 1 and 2 on noncertified
x-ray systems, provided the registrant makes a written application for such
exemption and demonstrates in the application:
(a) That it is impractical to comply with paragraphs 1 and 2; and
(b) The purpose of paragraphs 1 and 2 will be met by other means.
b. Additional requirements for stationary general purpose x-ray systems. In addition to the
requirements of subdivision a, all stationary x-ray systems both certified and noncertified
shall meet the following requirements:
(1) Means shall be provided to indicate when the axis of the x-ray beam is
perpendicular to the plane of the image receptor, to align the center of the x-ray field
with respect to the center of the image receptor to within two percent of the
source-image receptor distance, and to indicate the source-image receptor distance
to within two percent.
(2) The beam-limiting device shall numerically indicate the field size in the plane of the
image receptor to which it is adjusted.
(3) Indication of field size dimensions and source-image receptor distances shall be
specified in inches or centimeters, and shall be such that aperture adjustments

result in x-ray field dimensions in the plane of the image receptor which correspond
to those indicated by the beam-limiting device to within two percent of the
source-image receptor distance when the beam axis is indicated to be
perpendicular to the plane of the image receptor.
c. X-ray systems designed for one image receptor size. Radiographic equipment designed
for only one image receptor size at the fixed source-image receptor distance shall be
provided with means to limit the field at the plane of the image receptor to dimensions no
greater than those of the image receptor, and to align the center of the x-ray field with the
center of the image receptor to within two percent of the source-image receptor distance,
or shall be provided with means to both size and align the x-ray field such that the x-ray
field at the plane of the image receptor does not extend beyond any edge of the image
receptor.
d. Systems designed for or provided with special attachments for mammography.
Radiographic systems designed only for mammography shall be provided with means to
limit the useful beam such that the x-ray field at the plane of the image receptor does not
extend beyond any edge of the image receptor at any designated source-image receptor
distance except the edge of the image receptor designed to be adjacent to the chest wall
where the x-ray field may not extend beyond this edge by more than two percent of the
source-image receptor distance. This requirement can be met with a system which
performs as prescribed in paragraph 3 of subdivision e. When the beam-limiting device
and image receptor support device are designed to be used to immobilize the breast
during a mammographic procedure and the source-image receptor distance may vary,
the source-image receptor distance indication specified in subparagraphs a and b of
paragraph 3 of subdivision e shall be the maximum source-image receptor distance for
which beam limiting device or aperture is designed. In addition, each image receptor
support intended for installation on a system designed only for mammography shall have
clear and permanent markings to indicate the maximum image receptor size for which it
is designed.
e. X-ray systems other than those described in subdivisions a, b, c, and d and veterinary
systems installed prior to January 1, 1998, and all portable veterinary x-ray systems.
(1) Means shall be provided to limit the x-ray field in the plane of the image receptor so
that such field does not exceed each dimension of the image receptor by more than
two percent of the source-image receptor distance when the axis of the x-ray beam
is perpendicular to the plane of the image receptor.
(2) Means shall be provided to align the center of the x-ray field with the center of the
image receptor to within two percent of the source-image receptor distance, or
means shall be provided to both size and align the x-ray field such that the x-ray
field at the plane of the image receptor does not extend beyond any edge of the
image receptor. Compliance shall be determined with the axis of the x-ray beam
perpendicular to the plane of the image receptor.
(3) Paragraphs 1 and 2 may be met with a system that meets the requirements for a
general purpose x-ray system as specified in subsection 1, or, when alignment
means are also provided, may be met with either:
(a) An assortment of removable, fixed aperture, beam-limiting devices sufficient to
meet the requirement for each combination of image receptor size and
source-image receptor distance for which the unit is designed with each such
device having clear and permanent markings to indicate the image receptor
size and source-image receptor distance for which it is designed; or

(b) A beam-limiting device having multiple fixed apertures sufficient to meet the
requirement for each combination of image receptor size and source-image
receptor distance for which the unit is designed. Permanent, clearly legible
markings shall indicate the image receptor size and source-image receptor
distance for which each aperture is designed and shall indicate which aperture
is in position for use.
2. Beam limitation requirements applicable to certified systems only. Diagnostic x-ray
systems incorporating one or more certified components shall be required to comply with the
following additional requirements which relate to those certified components.
a. Beam limitation for stationary and mobile general purpose x-ray systems.
(1) There shall be provided a means of independent length and width stepless
adjustment of the size of the x-ray field. The minimum field size at a source-image
receptor distance of one hundred centimeters shall be equal to or less than five
centimeters by five centimeters.
(2) When a light localizer is used to define the x-ray field, it shall provide an average
illumination of not less than one hundred sixty lux or fifteen foot candles at one
hundred centimeters or at the maximum source-image receptor distance, whichever
is less. The average illumination shall be based upon measurements made in the
approximate center of each quadrant of the light field.
(3) The edge of the light field at one hundred centimeters or at the maximum
source-image receptor distance, whichever is less, shall have a contrast ratio,
corrected for ambient lighting, of not less than four in the case of beam-limiting
devices designed for use on stationary equipment, and a contrast ratio of not less
than three in the case of beam-limiting devices designed for use on mobile
equipment. The contrast ratio is defined as I /I where I is the illumination three
1 2 1
millimeters from the edge of the light field toward the center of field; and I is the
illumination three millimeters from the edge of the light field away from the center of
the field. Compliance shall be determined with a measuring instrument aperture of
one millimeter in diameter.
b. Beam limitation for portable x-ray systems. Beam limitation for portable x-ray systems
shall meet the beam limitation requirements of subdivision a of subsection 1 and
subdivision a of this subsection.
c. Beam limitation and alignment on stationary general purpose x-ray systems equipped
with positive beam limitation (PBL). The useful beam shall be limited to the area of
clinical interest. This shall be deemed to have been met if a positive beam-limiting device
meeting manufacturer's specifications and the requirements of this subdivision have
been properly used.
(1) Positive beam limitation (PBL), when provided, shall function as described in
paragraph 2 whenever all of the following conditions are met:
(a) The image receptor is inserted into a permanently mounted cassette holder.
(b) The image receptor length and width are each less than fifty centimeters.
(c) The x-ray beam axis is within plus or minus three degrees of vertical and the
source-image receptor distance is ninety centimeters to one hundred thirty
centimeters inclusive, or the x-ray beam axis is within plus or minus three
degrees of horizontal and the source-image receptor distance is ninety
centimeters to two hundred five centimeters inclusive.

(d) The x-ray beam axis is perpendicular to the plane of the image receptor to
within plus or minus three degrees.
(e) Neither tomographic nor steroscopic radiography is being performed.
(f) The positive beam limitation system has not been intentionally overridden. The
override provision is subject to paragraph 3.
(2) Positive beam limitation (PBL), when provided, shall prevent the production of
x-rays when:
(a) Either the length or width of the x-ray field in the plane of the image receptor
differs, except as permitted by paragraph 5, from the corresponding image
receptor dimensions by more than three percent of the source-image receptor
distance.
(b) The sum of the length and width differences as stated in subparagraph a,
without regard to sign, exceeds four percent of the source-image receptor
distance.
(c) The beam-limiting device is at a source-image receptor distance for which
positive beam limitation (PBL) is not designed for sizing.
(3) If a means of overriding the positive beam limitation (PBL) system exists, that
method:
(a) If located in a position that the operator would consider it part of the
operational controls or if it is referenced in the operator's manual or in other
materials intended for the operator.
[1] Must require that a key be utilized to defeat the positive beam limitation;
[2] Must require that the key remain in place during the entire time the
positive beam limitation system is overridden; and
[3] Must require that the key or key switch be clearly and durably labeled as
follows:
(b) Must include a label visible to the operator that override of the positive beam
limitation system is engaged.
(4) Compliance with paragraph 2 must be determined when the requirements of
paragraph 1 are met. Compliance must be determined no sooner than five seconds
after insertion of the image receptor.
(5) The positive beam limitation system must be capable of operation, at the discretion
of the operator, such that the size of the field may be made smaller than the size of
the image receptor through stepless adjustment of the field size. The minimum field
size at the source-image receptor distance of one hundred centimeters must be
equal to or less than five centimeters by five centimeters.
(6) The positive beam limitation system must be designed such that if a change in
image receptor does not cause an automatic return to positive beam limitation

function as described in paragraph 2, then any change of image receptor size or
source-image receptor distance must cause the automatic return.
3. Radiation exposure control.
a. Exposure initiation. Means shall be provided to initiate the radiation exposure by a
deliberate action on the part of the operator, such as the depression of a switch.
Radiation exposure shall not be initiated without such an action. In addition, it shall not
be possible to initiate an exposure when the timer is set to a "zero" or "off" position if
either position is provided.
b. Exposure indication. Means shall be provided for visual indication observable at or from
the operator's protected position whenever x-rays are produced. In addition, a signal
audible to the operator shall indicate that the exposure has terminated.
c. Exposure termination. Means shall be provided to terminate the exposure at a preset
time interval, preset product of current and time, a preset number of pulses, or a preset
radiation exposure to the image receptor. Except for dental panoramic systems,
termination of an exposure shall cause automatic resetting of the timer to its initial setting
or to "zero". It shall not be possible to make an exposure when the timer is set to a zero
or off position if either position is provided.
(1) Manual exposure control. An x-ray control which shall be the equivalent of a
dead-man switch shall be incorporated into each x-ray system such that an
exposure can be terminated by the operator at any time except for:
(a) Exposure of one-half second or less; or
(b) During serial radiography when means shall be provided to permit completion
of any single exposure of the series in process.
(2) Automatic exposure controls. When an automatic exposure control is provided:
(a) Indication shall be made on the control panel when this mode of operation is
selected;
(b) If the x-ray tube potential is equal to or greater than fifty kVp, the minimum
exposure time for field emission equipment rated for pulsed operation shall be
equal to or less than a time interval equivalent to two pulses;
(c) The minimum exposure time for all equipment other than that specified in
subparagraph b shall be equal to or less than one-sixtieth second or a time
interval required to deliver five mAs, whichever is greater;
(d) Either the product of peak x-ray tube potential, current, and exposure time
shall be limited to not more than sixty kWs per exposure, or the product of
x-ray tube current and exposure time shall be limited to not more than
six hundred mAs per exposure except that, when the x-ray tube potential is
less than fifty kVp, the product of x-ray tube current and exposure time shall be
limited to not more than two thousand mAs per exposure; and
(e) A visible signal shall indicate when an exposure has been terminated at the
limits required by subparagraph d, and manual resetting shall be required
before further automatically timed exposures can be made.
d. Exposure duration (timer) linearity. For systems having independent selection of
exposure time settings, the average ratios [X ] of exposure to the indicated timer setting,

in units of coulombs per kilogram per second [milliroentgen per second], obtained at any
two clinically used timer settings shall not differ by more than ten-hundredths times their
sum. This is written as:
1 2 1 2
where X and X are the average C kg-1s-1 (mR/s) values.
1 2
e. Exposure control location. The x-ray exposure control shall be so placed that the
operator can view the patient while making exposures (see appendix B).
f. Operator protection, except veterinary systems.
(1) Stationary systems. Stationary x-ray systems shall be required to have the x-ray
control permanently mounted in a protected area so that the operator is required to
remain in that protected area during the entire exposure (see appendix B).
(2) Mobile and portable systems. Mobile and portable x-ray systems which are:
(a) Used continuously for greater than one week in the same location, i.e., a room
or suite, shall meet the requirements of paragraph 1; and
(b) Used for less than one week at the same location shall be provided with either
a protective barrier at least two meters [6.5 feet] high for operator protection
during exposures, or means shall be provided to allow the operator to be at
least two and seven-tenths meters [9 feet] from the tube housing assembly
during the exposure.
(3) Mammography systems shall be operable from a shielded position.
g. Operator protection for veterinary systems. All stationary, mobile, or portable x-ray
systems used for veterinary work shall be provided with either a two-meter [6.5-foot] high
protection barrier for operator protection during exposures, or shall be provided with
means to allow the operator to be at least two and seven-tenths meters [9 feet] from the
tube housing assembly during exposures.
4. Source-to-skin distance. All mobile or portable radiographic systems shall be provided with
means to limit the source-to-skin distance equal to or greater than thirty centimeters, except
for veterinary systems.
5. Radiation exposure reproducibility. When all technique factors are held constant, including
control panel selections associated with automatic exposure control systems, the coefficient of
variation of exposure for both manual and automatic exposure control systems shall not
exceed five hundredths. This requirement applies to clinically used techniques. This
requirement shall be deemed to have been met if, when four radiation exposures are made at
identical technique factors, the value of the average radiation exposure (E) is greater than or
equal to five times the maximum radiation exposure (E ) minus the minimum radiation
max
exposure (E ),
min
6. Radiation from capacitor energy storage equipment in standby status. Radiation emitted
from the x-ray tube when the system is fully charged and the exposure switch or timer is not

activated shall not exceed a rate of two milliroentgens per hour at five centimeters from any
accessible surface of the diagnostic source assembly, with the beam-limiting device fully open.
7. Accuracy. Deviation of measured technique factors from indicated values of kVp and
exposure time shall not exceed the limits specified for that system by its manufacturer. In the
absence of manufacturer's specifications, the deviation shall not exceed ten percent of the
indicated value for kVp and twenty percent for time.
8. mA/mAs linearity. The following requirements apply when the equipment is operated on a
power supply as specified by the manufacturer for any fixed x-ray tube potential within the
range of forty percent to one hundred percent of the maximum rated:
a. Equipment having independent selection of x-ray tube current (mA). The average ratios
(X of exposure to the indicated milliampere-seconds product in units of coulombs per
1)
kilogram per milliampere second (or milliroentgen per milliampere seconds) obtained at
any two consecutive tube current settings shall not differ by more than ten hundredths
times their sum:
1 2 1 2
where X and X are the average values obtained at each of two consecutive tube current
1 2
settings, or at two settings differing by no more than a factor of two where the tube
current selection is continuous.
b. Equipment having a combined x-ray tube current exposure time product (mAs) selector,
but not a separate tube current (mA) selector. The average ratio (X ) of exposure to the
indicated milliampere-seconds product, in units of coulombs per kilogram per milliampere
second (or milliroentgen per milliampere seconds), obtained at any two consecutive mAs
selector settings shall not differ by more than ten hundredths times their sum:
1 2 1 2
where X and X are the average values obtained at any two consecutive mAs selector
1 2
settings, or at two settings differing by no more than a factor of two where the mAs
selector provided continuous selection.
c. Measuring compliance. Determination of compliance shall be based on four exposures
taken within a time period of one hour, at each of the two settings. These two settings
may include any two focal spot sizes except where one is equal to or less than forty-five
hundredths millimeters and the other is greater than forty-five hundredths millimeters. For
purposes of this requirement, focal spot size is the nominal focal spot size specified by
the x-ray tube manufacturer.
9. Other requirements:
a. Transmission limit for image receptor supporting devices used for mammography. For
x-ray systems manufactured after September 5, 1978, which are designed only for
mammography, the transmission of the primary beams through the image receptor
support provided with the system will be limited such that the exposure five centimeters
from any accessible surface beyond the plane of the image receptor supporting device
does not exceed twenty-five and eight-tenths microcoulomb per kilogram
[.01 milliroentgen] for each activation of the tube. Exposure shall be measured with the
system operated at the minimum source-image receptor distance for which it is designed.
Compliance shall be determined at the maximum rated peak tube potential for the

system and at the maximum rated product of tube current and exposure time
(milliampere second) for that peak tube potential. Compliance shall be determined by
measurements averaged over an area of one hundred square centimeters with no linear
dimension greater than twenty centimeters.
b. Tube stands for portable x-ray systems. A tube stand or other mechanical support shall
be used for portable x-ray systems, so that the x-ray tube housing assembly need not be
handheld during exposures.
History: Effective January 1, 2019.
General Authority: NDCC 23.1-03-04; S.L. 2017, ch. 199, § 1
Law Implemented: NDCC 23.1-02-03, 23.1-03-03, 23.1-03-04; S.L. 2017, ch. 199, §§ 17, 18
### § 33.1-10-06-07. Intraoral dental radiographic systems.

In addition to the requirements of sections 33.1-10-06-03 and 33.1-10-06-04, the requirements of
this section apply to x-ray equipment and associated facilities used for dental radiography. Criteria for
extraoral dental radiographic systems are covered in section 33.1-10-06-06. Only systems meeting the
requirements of this section shall be used.
1. Source-to-skin distance. X-ray systems designed for use with an intraoral image receptor
shall be provided with means to limit source-to-skin distance to not less than:
a. Eighteen centimeters if operable above fifty kilovolts peak.
b. Ten centimeters if operable at fifty kilovolts peak only.
2. Beam limitation. Radiographic systems designed for use with an intraoral image receptor
shall be provided with means to limit the x-ray beam such that:
a. The x-ray beam, at the minimum source-to-skin distance, shall be containable in a circle
having a diameter of no more than seven centimeters.
b. An open-ended shielded position indicating device shall be used. The shielding shall be
equivalent to the requirements of subsection 4 of section 33.1-10-06-04.
3. Radiation exposure control.
a. Exposure initiation.
(1) Means shall be provided to initiate the radiation exposure by a deliberate action on
the part of the operator, such as the depression of a switch. Radiation exposure
shall not be initiated without such an action.
(2) It shall not be possible to make an exposure when the timer is set to a "zero" or "off"
position if either position is provided.
b. Exposure indication. Means shall be provided for visual indication observable at or from
the operator's protected position whenever x-rays are produced. In addition, a signal
audible to the operator shall indicate that the exposure has terminated.
c. Exposure termination.
(1) Means shall be provided to terminate the exposure at a preset time interval, preset
product of current and time, a preset number of pulses, or a preset radiation
exposure to the image receptor.

(2) An x-ray exposure control shall be incorporated into each x-ray system such that an
exposure can be terminated by the operator at any time, except for exposures of
one-half second or less.
(3) Termination of an exposure shall cause automatic resetting of the timer to its initial
setting or to "zero".
d. Exposure duration (timer) linearity. For systems having independent selection of
exposure time settings, the average ratios (X ) of exposure to the indicated timer setting,
in units of coulombs per kilogram per second [milliroentgen per second], obtained at any
two clinically used timer settings shall not differ by more than ten hundredths times their
sum.
1 2 1 2
where X and X are the average values.
1 2
e. Exposure control location and operator protection.
(1) Stationary x-ray systems shall be required to have the x-ray exposure control
permanently mounted in a protected area, so that the operator is required to remain
in that protected area during the entire exposure and so the operator can view the
patient while making the exposure.
(2) Mobile and portable x-ray systems which are:
(a) Used for greater than one week in the same location, i.e., a room or suite, shall
meet the requirements of paragraph 1.
(b) Used for less than one week in the same location shall be provided with either
a protective barrier at least two meters [6.5 feet] high for operator protection, or
means to allow the operator to be at least two and seven-tenths meters [9 feet]
from the tube housing assembly while making exposures.
(3) Hand-held dental x-ray equipment:
(a) Operators shall use all safety devices and follow safety procedures according
to the manufacturer.
(b) Operators shall wear a protective apron during exposure in accordance with
subparagraph b of paragraph 6 of subdivision a of subsection 1.
(c) Operators shall have dose monitoring in accordance with section
4. Reproducibility. When the equipment is operated on an adequate power supply as specified
by the manufacturer, the estimated coefficient of variation of radiation exposures shall be no
greater than five hundredths for any specific combination of selected technique factors.
5. mA/mAs linearity. The following requirements apply when the equipment is operated on a
power supply as specified by the manufacturer for any fixed x-ray tube potential within the
range of forty percent to one hundred percent of the maximum rated.
a. Equipment having independent selection of x-ray tube current (mA). The average ratios
(X ) of exposure to the indicated milliampere seconds product, in units of coulombs per
kilogram per milliampere second (or milliroentgen per milliampere seconds), obtained at

any two consecutive tube current settings shall not differ by more than ten hundredths
times their sum:
1 2 1 2
where X and X are the average values obtained at any two consecutive tube current
1 2
settings, or at two settings differing by no more than a factor of two where the tube
current selection is continuous.
b. Equipment having a combined x-ray tube current exposure time product (mAs) selector,
but not a separate tube current (mA) selector. The average ratios (X ) of exposure to the
indicated milliampere-seconds product, in units of coulombs per kilogram per milliampere
second (or mR/mAs), obtained at any two consecutive mAs selector settings shall not
differ by more than ten hundredths times their sum:
1 2 1 2
where X and X are the average values obtained by any two mAs selector settings, or at
1 2
two settings differing by no more than a factor of two where the mAs selector provides
continuous selection.
c. Measuring compliance. Determination of compliance shall be based on ten exposures
taken within a time period of one hour, at each of the two settings. These two settings
may include any two focal spot sizes except where one is equal to or less than forty-five
hundredths millimeters and the other is greater than forty-five hundredths millimeters. For
purposes of this requirement, focal spot size is the nominal focal spot size specified by
the x-ray tube manufacturer.
6. Accuracy. Deviation of technique factors from values for kVp and exposure time (if time is
independently selectable) shall not exceed the limits specified for that system by its
manufacturer. In the absence of manufacturer's specifications, the deviation shall not exceed
ten percent of the indicated value for kVp and twenty percent for time.
7. kVp limitations. Dental x-ray machines with a nominal fixed kVp of less than fifty kVp shall
not be used to make diagnostic dental radiographs of humans.
8. Beam quality. All dental x-ray systems are subject to the filtration requirements of
subdivision a of subsection 5 of section 33.1-10-06-04
9. Administrative controls.
a. Patient and film holding devices shall be used when the techniques permit.
b. The tube housing and the position indicating device shall not be handheld during an
exposure unless the system was specifically designed as a hand-held dental x-ray
machine.
c. The x-ray system shall be operated in such a manner that the useful beam at the
patient's skin does not exceed the requirements of subdivision a of subsection 2.
d. Dental fluoroscopy without image intensification shall not be used.
e. Security for portable dental systems. A means shall be provided to prevent unauthorized
use whenever the x-ray system is not under the control and constant surveillance of the
registrant or an authorized operator.

10. Structural shielding requirements (see appendix C).
History: Effective January 1, 2019.
General Authority: NDCC 23.1-03-04; S.L. 2017, ch. 199, § 1
Law Implemented: NDCC 23.1-03-03, 23.1-03-04; S.L. 2017, ch. 199, § 18
### § 33.1-10-06-08. [Reserved].

### § 33.1-10-06-09. [Reserved].

### § 33.1-10-06-10. [Reserved].

### § 33.1-10-06-11. Computed tomography x-ray systems.

1. Definitions. In addition to the definitions provided in sections 33.1-10-01-04 and
33.1-10-06-02, the following definitions are applicable to this section:
a. "Computed tomography dose index" means the integral from -7T to +7T of the dose
profile along a line perpendicular to the tomographic plane divided by the product of the
nominal tomographic section thickness and the number of tomograms produced in a
single scan, that is:
where:
z = Position along a line perpendicular to the tomographic plane.
D(z) = Dose at position z.
T = Nominal tomographic section thickness.
n = Number of tomograms produced in a single scan.
This definition assumes that the dose profile is centered around z = 0 and that, for a
multiple tomogram system, the scan increment between adjacent scans is nT.
b. "Contrast scale" means the change in the linear attenuation coefficient per computed
tomography number relative to water, that is:
where:
μ = Linear attenuation coefficient of the material of interest.
x

μ = Linear attenuation coefficient of water.
w
(CTN) = CTN of the material of interest.
x
(CTN) = CTN of water.
w
c. "CS" (see "contrast scale").
d. "CT" means a radiologic imaging technique that produces images of "slices" through a
patient's body.
e. "CT conditions of operation" means all selectable parameters governing the operation of
a CT x-ray system, including nominal tomographic section thickness, filtration, and the
technique factors as defined in section 33.1-10-06-02.
f. "CTDI" (see "computed tomography dose index").
g. "CT gantry" means the tube housing assemblies, beam-limiting devices, detectors, and
the supporting structures and frames which hold these components.
h. "CTN" (see "CT number").
i. "CT number" means the number used to represent the x-ray attenuation associated with
each elemental area of the CT image.
where:
k = A constant (The constant has a normal value of one thousand when the Houndsfield
scale of CTN is used.)
μ = Linear attenuation coefficient of the material of interest.
x
μ = Linear attenuation coefficient of water.
w
j. "Dose profile" means the dose as a function of position along a line.
k. "Elemental area" means the smallest area within a tomogram for which the x-ray
attenuation properties of a body are depicted. (see also "picture element").
l. "Multiple tomogram system" means a computed tomography x-ray system which obtains
x-ray transmission data simultaneously during a single scan to produce more than one
tomogram.
m. "Noise" means the standard deviation of the fluctuations in computed tomography
number expressed as a percentage of the attenuation coefficient of water. Its estimate
(S ) is calculated using the following expression:
n

where:
CS = Contrast scale.
μ = Linear attenuation coefficient of water.
w
s = Estimated standard deviation of the CTN of picture elements in a specified area of
the CT image.
n. "Nominal tomographic section thickness" means the full width at half maximum of the
sensitivity profile taken at the center of the cross sectional volume over which x-ray
transmission data are collected.
o. "Picture element" means an elemental area of a tomogram.
p. "Reference plane" means a plane which is displaced from and parallel to the
tomographic plane.
q. "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.
r. "Scan 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.
s. "Scan sequence" means a preselected set of two or more scans performed consecutively
under preselected CT conditions of operation.
t. "Scan time" means the period of time between the beginning and end of x-ray
transmission data accumulation for a single scan.
u. "Single tomogram system" means a CT x-ray system which obtains x-ray transmission
data during a scan to produce a single tomogram.
v. "Tomographic plane" means that geometric plane which is identified as corresponding to
the output tomogram.
w. "Tomographic section" means the volume of an object whose x-ray attenuation properties
are imaged in a tomogram.
2. Requirements for equipment.
a. Termination of exposure.
(1) Means must be provided to terminate the x-ray exposure automatically by either
de-energizing the x-ray source or shuttering the x-ray beam in the event of
equipment failure affecting data collection. Such termination must occur within an
interval that limits the total scan time to no more than one hundred ten percent of its

preset value through the use of either a backup timer or devices which monitor
equipment function.
(2) A visible signal must indicate when the x-ray exposure has been terminated through
the means required by paragraph 1.
(3) The operator must be able to terminate the x-ray exposure at any time during a
scan, or series of scans under computed tomography x-ray system control, of
greater than one-half second duration.
b. Tomographic plane indication and alignment.
(1) For any single tomogram system, means must be provided to permit visual
determination of the tomographic plane or a reference plane offset from the
tomographic plane.
(2) For any multiple tomogram system, means shall be provided to permit visual
determination of the location of a reference plane. This reference plane can be
offset from the location of the tomographic planes.
(3) If a device using a light source is used to satisfy paragraph 1 or 2, the light source
must provide illumination levels sufficient to permit visual determination of the
location of the tomographic plane or reference plane under ambient light conditions
of up to five hundred lux.
c. Beam-on and shutter status indicators and control switches.
(1) The computed tomography x-ray control and gantry must provide visual indication
whenever x-rays are produced and, if applicable, whether the shutter is open or
closed.
(2) Each emergency button or switch must be clearly labeled as to its function.
d. Indication of computed tomography conditions of operation. The computed tomography
x-ray system must be designed such that the computed tomography conditions of
operation to be used during a scan or a scan sequence must be indicated prior to the
initiation of a scan or a scan sequence. On equipment having all or some of these
conditions of operation at fixed values, this requirement may be met by permanent
markings. Indication of computed tomography conditions of operation must be visible
from any position from which scan initiation is possible.
e. Extraneous radiation. When data are not being collected for image production, the
radiation adjacent to the tube port may not exceed that permitted by subsection 3 of
section 33.1-10-06-04.
f. Maximum surface computed tomography dose index identification. The angular position
where the maximum surface computed tomography dose index occurs must be identified
to allow for reproducible positioning of a computed tomography dosimetry phantom.
g. Additional requirements applicable to computed tomography x-ray systems containing a
gantry manufactured after September 3, 1985.
(1) The total error in the indicated location of the tomographic plane or reference plane
may not exceed five millimeters.
(2) If the x-ray production period is less than one-half second, the indication of x-ray
production must be actuated for at least one-half second. Indicators at or near the

gantry must be discernible from any point external to the patient opening where
insertion of any part of the human body into the primary beam is possible.
(3) The deviation of indicated scan increment versus actual increment may not exceed
plus or minus one millimeter with any mass from zero to one hundred kilograms
resting on the support device. The patient support device must be incremented from
a typical starting position to the maximum incremented distance or thirty
centimeters, whichever is less, and then returned to the starting position.
Measurement of actual versus indicated scan increment may be taken anywhere
along this travel.
(4) Premature termination of the x-ray exposure by the operator shall necessitate
resetting of the computed tomography conditions of operation prior to the initiation
of another scan.
h. Facility design requirements.
(1) All CT capable systems shall be required to have the x-ray control permanently
mounted in a protected area during the entire exposure (see appendix B).
(2) Aural communication. Provision must be made for two-way aural communication
between the patient and the operator at the control panel.
i. Surveys, calibrations, spot checks, and operating procedures.
(1) Surveys.
(a) All computed tomography x-ray systems installed after March 1, 1992, and
those systems not previously surveyed shall have a survey made by, or under
the direction of, a qualified expert. In addition, such surveys must be done after
any change in the facility or equipment which might cause a significant
increase in radiation hazard.
(b) The registrant shall obtain a written report of the survey from the qualified
expert, and a copy of the report must be made available to the department
upon request.
(2) Radiation calibrations.
(a) The calibration of the radiation output of the computed tomography x-ray
system must be performed by, or under the direction of, a qualified expert who
is physically present at the facility during such calibration.
(b) The calibration of a computed tomography x-ray system must be performed at
intervals specified by a qualified expert and after any change or replacement of
components which, in the opinion of the qualified expert, could cause a change
in the radiation output.
(c) The calibration of the radiation output of a computed tomography x-ray system
must be performed with a calibrated dosimetry system. The calibration of such
system must be traceable to a national standard. The dosimetry system must
have been calibrated within the preceding two years.
(d) Computed tomography dosimetry phantoms must be used in determining the
radiation output of a computed tomography x-ray system. Such phantoms must
meet the following specifications and conditions of use:

[1] Computed tomography dosimetry phantoms must be right circular
cylinders of polymethyl methacrylate of density one point nineteen plus or
minus point zero one grams per cubic centimeter. The phantoms must be
at least fourteen centimeters in length and must have diameters of
thirty-two centimeters for testing computed tomography x-ray systems
designed to image any section of the body and sixteen centimeters for
systems designed to image the head or for whole-body scanners
operated in the head scanning mode.
[2] Computed tomography dosimetry phantoms must provide means for the
placement of a dosimeter along the axis of rotation and along a line
parallel to the axis of rotation one centimeter from the outer surface and
within the phantom. Means for the placement of dosimeters or alignment
devices at other locations may be provided.
[3] Any effects on the doses measured due to the removal of phantom
material to accommodate dosimeters must be accounted for through
appropriate corrections to the reported data or included in the statement
of maximum deviation for the values obtained using the phantom.
[4] All dose measurements must be performed with the computed
tomography dosimetry phantom placed on the patient couch or support
device without additional attenuation materials present.
(e) The calibration shall be required for each type of head, body, or whole-body
scan performed at the facility.
(f) Calibration must meet the following requirements:
[1] The dose profile along the center axis of the computed tomography
dosimetry phantom for the minimum, maximum, and midrange values of
the nominal tomographic section thickness used by the registrant shall be
measurable. Where less than three nominal tomographic thicknesses can
be selected, the dose profile determination must be performed for each
available nominal tomographic section thickness.
[2] The computed tomography dose index (For the purpose of determining
the computed tomography dose index, the manufacturer's statement as to
the nominal tomographic section thickness for that particular system may
be utilized.) along the two axes specified in item 2 of subparagraph d
must be measured. The computed tomography dosimetry phantom must
be oriented so that the measurement point one centimeter from the outer
surface and within the phantom is in the same angular position within the
gantry as the point of maximum surface computed tomography dose
index identified. The computed tomography conditions of operation must
correspond to typical values used by the registrant.
[3] The spot checks specified in paragraph 3 of subdivision i must be made.
(g) Calibration procedures must be in writing. Records of calibrations performed
must be maintained for inspection by the department.
(3) Spot checks.
(a) The spot check procedures must be in writing and must have been developed
by a qualified expert.

(b) The spot check procedures must incorporate the use of a computed
tomography dosimetry phantom which has a capability of providing an
indication of contrast scale, noise, nominal tomographic section thickness, the
resolution capability of the system for low and high contrast objects, and
measuring the mean computed tomography number for water or other
reference material.
(c) All spot checks must be included in the calibration required by paragraph 2 and
at time intervals and under system conditions specified by a qualified expert.
(d) Spot checks must include acquisition of images obtained with the computed
tomography dosimetry phantoms using the same processing mode and
computed tomography conditions of operation as are used to perform
calibrations required by paragraph 2 of subdivision i. The images must be
retained, until a new calibration is performed, in two forms as follows:
[1] Photographic copies of the images obtained from the image display
device; and
[2] Images stored in digital form on a storage medium compatible with the
computed tomography x-ray system.
(e) Written records of the spot checks performed shall be maintained for
inspection by the department.
(4) Operating procedures.
(a) The computed tomography x-ray system may not be operated except by an
individual who has been specifically trained in its operation.
(b) Information must be available at the control panel regarding the operation and
calibration of the system. Such information must include the following:
[1] Dates of the latest calibration and spot checks and the location within the
facility where the results of those tests may be obtained;
[2] Instructions on the use of the computed tomography dosimetry phantoms,
including a schedule of spot checks appropriate for the system, allowable
variations for the indicated parameters, and the results of at least the
most recent spot checks conducted on the system;
[3] The distance in millimeters between the tomographic plane and the
reference plane if a reference plane is utilized; and
[4] A current technique chart available at the control panel which specifies for
each routine examination the computed tomography conditions of
operation and the number of scans per examination.
(c) If the calibration or spot check of the computed tomography x-ray system
identifies that a system operating parameter has exceeded a tolerance
established by the qualified expert, use of the computed tomography x-ray
system on patients must be limited to those uses permitted by established
written instructions of the qualified expert.
History: Effective January 1, 2019.
General Authority: NDCC 23.1-03-04; S.L. 2017, ch. 199, § 1
Law Implemented: NDCC 23.1-03-03, 23.1-03-04; S.L. 2017, ch. 199, § 18

### § 33.1-10-06-12. Bone densitometry.

1. Bone densitometry systems shall be:
a. Certified by the manufacturer pursuant to the Medical Device Act and part C - electronic
product radiation control (EPRC) of chapter V of the Federal Food, Drug and Cosmetic
Act;
b. Registered in accordance with chapter 33.1-10-02 of these regulations; and
c. Maintained and operated in accordance with the manufacturer's specifications.
2. Equipment requirements. Systems with stepless collimators shall be provided with means to
both size and align the x-ray field such that the x-ray field at the plane of the image receptor
does not extend beyond two percent of the source-image receptor distance.
3. Operators of bone densitometry systems shall complete a training course on the bone
densitometry which is acceptable to the department. The training course shall include:
a. Basic radiation protection;
b. Operating procedures for bone densitometry systems, to include use of various system
functions, safety, and maintenance; and
c. Patient positioning for the type of examinations performed.
4. During the operation of any bone densitometry system:
a. The operator, ancillary personnel, and members of the general public shall be positioned
as far away as practical but not less than two meters from the patient and bone
densitometry system during the examination.
b. The operator shall advise the patient that the bone densitometry examination is a type of
x-ray procedure.
5. The registrant shall keep maintenance records for bone densitometry systems as prescribed
by subdivision b of subsection 1 of section 33.1-10-06-03. These records shall be maintained
for inspection by the department.
6. Bone densitometry on human patients shall be conducted only:
a. Under a prescription of a licensed practitioner of the healing arts; or
b. Under a screening program approved by the department.
7. Any person proposing to conduct a bone densitometry screening program shall submit the
information outlined in appendix E.
History: Effective January 1, 2019.
General Authority: NDCC 23.1-03-04; S.L. 2017, ch. 199, § 1
Law Implemented: NDCC 23.1-03-03, 23.1-03-04; S.L. 2017, ch. 199, § 18

In order for the department to provide an evaluation, technical advice, and official approval on shielding
requirements for a radiation installation, the following information shall be submitted:
1. The plans should show, as a minimum, the following:
a. The normal location of the x-ray system's radiation port; the port's travel and traverse
limits; general direction or directions of the useful beam; locations of any windows and
doors; the location of the operator's booth; and the location of the x-ray control panel.
b. Structural composition and thickness or lead equivalent of all walls, doors, partitions,
floor, and ceiling of the room or rooms concerned.
c. The dimensions of the room or rooms concerned.
d. The type of occupancy of all adjacent areas inclusive of space above and below the
room or rooms concerned. If there is an exterior wall, show distance to the closest area
or areas where it is likely that individuals may be present.
e. The make and model of the x-ray equipment and the maximum technique factors.
f. The type of examinations or treatments which will be performed with the equipment, e.g.,
dental, orthodontal, chest, gastrointestinal, fluoroscopic, podiatry, fixed therapy, rotational
therapy, etc.
2. Information on the anticipated workload of the x-ray systems.
3. If the services of a qualified expert have been utilized to determine the shielding requirements,
a report, including all basic assumptions used, must be submitted with the plans.
History: Effective January 1, 2019.

1. Space requirements.
a. The operator shall be allotted not less than seven and five-tenths square feet
[0.697 square meter] of unobstructed floor space in the booth.
b. The operator's booth may be any geometric configuration with no dimension of less than
two feet [0.61 meters].
c. The space shall be allotted excluding any encumbrance by the console, such as
overhang, cables, or other similar encroachments.
d. The booth must be located or constructed such that unattenuated direct scatter radiation
originating on the examination table or at the wall cassette not reach the operator's
station in the booth.
2. Structural requirements.
a. The booth walls shall be permanently fixed barriers of at least seven feet [2.13 meters]
high.
b. When a door or movable panel is used as an integral part of the booth structure, it must
have an interlock which will prevent an exposure when the door or panel is not closed.
c. Shielding must be provided to meet the requirements of chapter 33.1-10-04.2 of these
rules.
3. X-ray control placement. The x-ray control for the system shall be fixed within the booth and:
a. Shall be at least forty inches [1.02 meters] from any open edge of the booth wall which is
nearest to the examining table.
b. Shall allow the operator to use the majority of the available viewing windows.
4. Viewing system requirements.
a. Each booth shall have at least one viewing device which will:
(1) Be so placed that the operator can view the patient during any exposure; and
(2) The device shall be so placed that the operator can have full view of any occupant
of the room and should be so placed that the operator can view any entry into the
room. If any door, which allows access to the room, cannot be seen from the booth,
then that door must have an interlock controlling the exposure which will prevent the
exposure if the door is not closed.
b. When the viewing system is a window, the following requirements also apply:
(1) The viewing area must be at least one square foot [0.0929 square meter].
(2) The design of the booth must be such that the operator's expected position when
viewing the patient and operating the x-ray system is at least eighteen inches
[0.457 meter] from the edge of the booth.
(3) The material constituting the window must have the same lead equivalence as that
required in the booth's wall in which it is mounted.

c. When the viewing system is by mirrors, the mirrors must be so located as to accomplish
the general requirements of subdivision a.
d. When the viewing system is by electronic means:
(1) The camera shall be so located as to accomplish the general requirements in
subdivision a; and
(2) There shall be an alternate viewing system as a backup for the primary system.
History: Effective January 1, 2019.

1. General requirements.
a. Each installation must be provided with such primary or secondary barriers as are
necessary to assure compliance with section 33.1-10-04.2-01 [10 CFR 20.1201,
20.1207, 20.1208, and 20.1301]. This requirement must be deemed to be met if the
thicknesses of such barriers are equivalent to those as computed in accordance with
appendices B, C, and D of the National Council on Radiation Protection and
Measurements Report No. 49, "Medical X-Ray and Gamma-Ray Protection for Energies
Up to 10 MeV", modified to meet current dose limits.
b. Lead barriers must be mounted in such manner that they will not sag or cold-flow
because of their own weight and shall be protected against mechanical damage.
c. Joints between different kinds of protective materials must be designed so that the
overall protection of the barrier is not impaired.
d. Joints at the floor and ceiling must be so designed that the overall protection is not
impaired.
e. Windows, window frames, doors, and door frames must have the same lead equivalent
as that required of the adjacent wall.
f. Holes in protective barriers must be covered so that overall attenuation is not impaired.
2. Fluoroscopic x-ray systems. Ordinarily only secondary barriers are necessary except
combined fluoroscopic-radiographic installations.
3. Radiographic systems other than fluoroscopic, dental intraoral, or veterinarian systems:
a. All wall, floor, and ceiling areas exposed to the useful beam must have primary barriers.
Primary barriers in walls must extend to a minimum height of eighty-four inches
[2.13 meters] above the floor.
b. Secondary barriers must be provided in all wall, floor, and ceiling areas not having
primary barriers or where the primary barrier requirements are lower than the secondary
requirements.
c. The operator's station at the control shall be behind a protective barrier, either in a
separate room, in a protected booth, or behind a shield which will intercept the useful
beam and any radiation which has been scattered only once.
d. A window of lead equivalent glass equal to that required by the adjacent barrier or a
mirror system shall be provided large enough and so placed that the operator can see
the patient without having to leave the protected area during exposure.
e. For mobile and portable x-ray systems which are used for greater than one week in
one location (one room or suite), the requirements of this appendix shall apply.
4. Intraoral dental radiographic systems.
a. Dental rooms containing x-ray machines shall be provided with primary barriers at all
areas struck by the useful beam. Consideration shall be given to the attenuation provided
by the patient.

b. When dental x-ray units are installed in adjacent rooms or areas, protective barriers shall
be provided between the rooms or areas.
Note: In many cases, structural materials of ordinary walls suffice as a protective barrier without
addition of special shielding material.
5. Therapeutic x-ray installations. The structural shielding requirements shall be deemed to be
met if the barriers have been designed and constructed in accordance with the National
Council on Radiation Protection and Measurements Report No. 49, "Medical X-Ray and
Gamma-Ray Protection for Energies Up to 10 MeV", modified to meet current dose limits.
6. Veterinary medicine radiographic installations.
a. All wall, floor, and ceiling areas exposed to the useful beam shall have primary barriers.
Primary barriers in walls shall extend to a minimum height of eighty-four inches
[2.13 meters] above the floor.
b. Secondary barriers shall be provided in all wall, floor, and ceiling areas not having
primary barriers or where the primary barrier requirements are lower than the secondary
requirements.
History: Effective January 1, 2019.

Time Temperature Chart
Thermometer Readings (Degrees) Minimum Developing Times (Minutes)
27 - 80 2
79 2
78 2 1/2
77 2 1/2
24 - 76 3
75 3
74 3 1/2
73 3 1/2
22 - 72 4
71 4
70 4 1/2
69 4 1/2
20 - 68 5
67 5 1/2
66 5 1/2
65 6
18 - 64 6 1/2
63 7
62 8
61 8 1/2
16 - 60 9 1/2
Processing of Film
1. Manual processing of film.
a. Where film is developed manually, processing tanks should be made of mechanically
rigid, corrosion resistant material and the temperature of solutions in the tanks shall be
maintained within the range of sixteen degrees Celsius to twenty-seven degrees Celsius
[60-80 degrees Fahrenheit]. Film shall be developed in accordance with the
time-temperature relationships recommended by the film manufacturer, or, in the
absence of such recommendations, with the above time-temperature chart.
b. Devices shall be available which will give all of the following:
(1) The actual temperature of the developer.
(2) An audible or visible signal, after a preset time (in minutes of duration).
2. Automatic processors and other closed processing systems.
a. Film shall be developed in accordance with the time-temperature relationships
recommended by the film manufacturer.

b. The specified developer temperature and immersion time shall be posted in the
darkroom or on the automatic processor.
c. Preventive maintenance shall be performed on the unit, except for extended periods of
nonuse, on a frequency basis which is not less than that schedule recommended by the
manufacturer. In the event that no schedule is available from the manufacturer a
maintenance schedule shall be established which will preserve good film quality.
d. After a full cleansing of the processor a film shall be exposed to a density of
approximately one, with one-half of the film protected exposure. It will be developed and
then kept near the unit and daily at least one test film (exposed under techniques
identical with those used for the original test film) shall be compared with the original test
film to evaluate the adequacy of the unit's developing capability and base fog level.
3. Processing deviations from the requirements of appendix D shall be documented by the
registrant in such manner that the requirements are shown to be met or exceeded (e.g.,
extended processing, and special rapid chemistry).
4. Other requirements:
a. Pass boxes, if provided, shall be so constructed as to exclude light from the darkroom
when cassettes are placed in or removed from the boxes, and shall incorporate adequate
shielding from stray radiation to prevent exposure of undeveloped film.
b. The darkroom shall be light tight and use proper safelighting such that any film type in
use exposed in a cassette to x-radiation sufficient to produce an optical density from one
to two when processed shall not suffer an increase in density greater than 0.1 (0.05 for
mammography) when exposed in the darkroom for two minutes with all safelights on. If
used, daylight film handling boxes shall preclude fogging of the film.
c. Darkrooms typically used by more than one individual shall be provided a method to
prevent accidental entry while undeveloped films are being handled or processed.
d. Film shall be stored in a cool, dry place and shall be protected from exposure to stray
radiation. Film in open packages shall be stored in a light tight container.
e. Film cassettes and intensifying screens shall be inspected periodically and shall be
cleaned and replaced as necessary to best assure radiographs of good diagnostic
quality.
f. Outdated x-ray film shall not be used for diagnostic radiographs, unless the film has been
stored in accordance with the manufacturer's recommendations and a sample of the film
passes a sensitometric test for normal ranges of base plus fog and speed.
g. Film developing solutions shall be prepared in accordance with the directions given by
the manufacturer, and shall be maintained in strength by replenishment or renewal so
that full development is accomplished within the time specified by the manufacturer.
History: Effective January 1, 2019.

Persons requesting that the department approve a healing arts screening program shall submit the
following information and evaluation:
1. Name and address of the applicant and, where applicable, the names and addresses of
agents within this state.
2. Diseases or conditions for which the x-ray examinations are to be used in diagnoses.
3. A detailed description of the x-ray examinations proposed in the screening program.
4. Description of the population to be examined in the screening program, i.e., age, sex, physical
condition, and other appropriate information.
5. An evaluation of any known alternate methods not involving ionizing radiation which could
achieve the goals of the screening program and why these methods are not used instead of
the x-ray examinations.
6. An evaluation by a qualified expert on the x-ray systems to be used in the screening program.
The evaluation by the qualified expert shall show that such systems do satisfy all requirements
of this article. The evaluation shall include a measurement of patient exposures from the x-ray
examinations to be performed.
7. A description of the diagnostic x-ray quality control program.
8. A copy of the technique chart for the x-ray examination procedures to be used.
9. The qualifications of each individual who will be operating the x-ray systems.
10. The qualifications of the individual who will be supervising the operators of the x-ray systems.
The extent of supervision and the method of work performance evaluation shall be specified.
11. The name and address of the individual who will interpret the radiographs.
12. A description of the procedures to be used in advising the individuals screened and their
private practitioners of the healing arts of the results of the screening procedure and any
further medical needs indicated.
13. A description of the procedures for the retention or disposition of the radiographs and other
records pertaining to the x-ray examinations.
14. An indication of the frequency of screening and the duration of the entire screening program.
History: Effective January 1, 2019.

The department may use interview, observation or testing, or both, to determine compliance. The
following are areas in which an individual shall have expertise for the competent operation of x-ray
equipment:
1. Fundamentals of radiation safety.
a. Characteristics of x-radiation.
b. Units of radiation dose (mrem).
c. Hazards of exposure to radiation.
d. Levels of radiation from sources of radiation.
e. Methods of controlling radiation dose.
(1) Working time.
(2) Working distance.
(3) Shielding.
(4) Collimation.
(5) Filtration.
(6) Gonad shielding and other patient protection devices.
(7) Restriction of x-ray beam to the image receptor.
(8) Grid utilization.
(9) Utilization of mechanical immobilization device.
2. Familiarization with equipment.
a. Identification of controls.
b. Function of each control.
c. How to use a technique chart.
3. Film processing.
a. Film speed as related to patient exposure.
b. Film processing parameters.
c. Quality assurance program.
4. Emergency procedures. Termination of exposure in event of automatic timing device failure.
5. Proper use of personnel dosimetry.
a. Location of dosimeter.

b. Interpretation of personnel monitoring reports.
6. Anatomy and positioning.
a. Relevant human anatomy.
b. Relevant human physiology.
c. Radiographic positioning.
7. The requirements of pertinent federal and state rules.
8. The licensee's or registrant's written operating and emergency procedures.
History: Effective January 1, 2019.

The following are individuals that qualify for training exemptions, approved Allied Health professions
which qualify for cross-training into diagnostic x-ray as a limited x-ray machine operator and individuals
who may order diagnostic x-rays to be taken by a limited x-ray machine operator outside the scope of
procedures in appendix I:
1. Individuals exempt from minimum training requirements in subparagraph b of paragraph 2 of
subdivision a of subsection 1 of section 33.1-10-06-03.
a. Medical doctors.
b. Chiropractors.
c. Doctors of osteopathy.
d. Podiatrists.
2. Prerequisite qualification: Individuals who qualify for cross-training as a limited x-ray machine
operator.
a. Nurse practitioner, registered nurse, licensed practical nurse.
b. Emergency medical technician paramedic.
c. Physical therapist, physical therapy assistant.
d. Occupational therapist, occupational therapy assistant.
e. Medical technologist, medical lab technician, clinical lab technician.
f. Physician assistant.
g. Orthopedic physician assistant.
3. Individuals who may order emergency x-ray examinations outside the scope of procedures in
appendix I to be taken by limited x-ray machine operators:
a. Medical doctor.
b. Doctor of osteopathy.
c. Physician assistant.
d. Nurse practitioner.
e. Chiropractor.
History: Effective January 1, 2019.

Students must meet the prerequisite requirements of item 1 of subparagraph b of paragraph 2 of
subdivision a of subsection 1 of section 33.1-10-06-03 and complete the training requirements of this
appendix.
Training requirements have been divided into two sections, didactic instruction and clinical
experience/supervision. Upon completion of didactic training, the individual must complete the clinical
experience requirements of either subdivision a or b of subsection 2 and demonstrate competence for
examinations listed in appendix I. Records must be maintained to demonstrate compliance with these
requirements.
1. Didactic instruction section: Individuals shall complete a minimum of eighty hours of didactic
training at a single course providing the minimum hours of instruction in the subjects below.
Correspondence coursework cannot exceed twenty percent of the eighty-hour course
(sixteen hours maximum). The course content should approximate the outline below. The
eighty-hour course is subject to department approval. Individuals must also complete the
three-hour self study course designed by the state health department. An examination is
required to demonstrate successful completion of a course.
a. Basic X-Ray Physics 12 hrs.
- General description of production of x-rays
- Function of filtration and effects it has on x-ray beam
- Collimation
- Types and function of beam-limiting devices
- Design, features, and function of x-ray tube
b. Radiobiology 1 hr.
- Effects of ionizing radiation to the human body
- Factors that cause somatic and genetic damage
c. Radiation Protection 6 hrs.
- ALARA concept
- Shielding materials
- Radiation quantity and units of measurement
- Basic interactions of x-ray with matter
- Primary and secondary scatter
- Importance of time, distance, shielding
- Maximum permissible dose-occupational/public
- Latency period
- Patient protection

d. Principles of Exposure 15 hrs.
- Factors that control and influence radiographic quality
- Properties of x-rays
- Size distortion caused by geometric parameters
- Parameters which cause shape distortion
- Technique factor selection
- 15% rule, mAs and kVp relationship
- Grid-types, ratios, and how they affect image quality
- Intensifying screens
- X-ray film
- Artifacts
- Inverse square law
e. Darkroom Procedure and Processing 4 hrs.
- Film storage and handling
- Film processing and troubleshooting
- Design, features, and function of a processor
- Silver recovery
- Quality assurance/quality control
f. Anatomy and Positioning
1. Chest 4 hrs.
2. Abdomen 4 hrs.
3. Extremity 8 hrs.
4. Spine 8 hrs.
5. Skull 8 hrs.
g. Pediatric 2 hrs.
h. Rules and Regulations 1 hr.
2. Clinical experience/supervision section. Individuals must complete either a or b below. If the
individual is unable to demonstrate clinical competence in a procedure due to a lack of
opportunity, the student shall complete the three prerequisite examinations required by
appendix J using simulation for subdivisions a through k of subsection 1 of appendix J. Final
demonstration of competence in subdivisions a through s of subsection 1 of appendix J should
be completed as soon as there is a patient requiring the procedure. No individual may perform
an unsupervised procedure for which they have not successfully completed the final
demonstration of competence.

a. The individual must complete three months of clinical training during which time they may
perform x-ray examinations only under direct supervision.
(1) Direct supervision and evaluation of competence shall be performed by a general
diagnostic operator or a limited x-ray machine operator with two years' experience.
(2) The individual shall utilize proper procedure as indicated in appendix J.
(3) The individual shall be evaluated on procedure, performance, and competency on
forms provided by the department for each of the examinations listed in appendix I;
or
b. Individuals must complete at least one hundred twenty hours of clinical training at a
facility where there is routinely fifty or more limited diagnostic x-ray examinations
performed per week. During this time they may perform x-ray examinations only under
direct supervision. After completing the one hundred twenty hours of training, the
individual must complete an additional three-month probationary training period as
outlined in number 4 of this part.
(1) Direct supervision and evaluation of competence shall be performed by a general
diagnostic operator or a limited x-ray machine operator with two years' experience.
(2) The individual shall utilize proper procedure as indicated in appendix J.
(3) The individual shall be evaluated on procedure, performance, and competency on
forms provided by the department for each of the examinations listed in appendix I.
(4) Upon completion of one hundred twenty clinical hours and demonstration of
competence in accordance with appendix J for limited x-ray machine operator
examinations:
(a) Individuals must complete a three-month probationary training period during
which time they may independently perform limited x-ray machine operator
examinations for the procedures which they have successfully demonstrated
competence.
(b) During the three-month probationary training, a general diagnostic operator, or
a limited x-ray machine operator with two years' experience, or a radiologist
must evaluate all films and conduct at least six hours of direct supervision on a
weekly basis and give feedback on any needed improvements.
[1] All films, including repeat and waste films, must be kept for evaluation.
[2] Evaluation must be done on forms supplied by the department.
History: Effective January 1, 2019.

Specific examinations that are allowed in the scope of practice for limited x-ray machine operators.
Chest: PA, lateral, decubitus
Ribs: AP, PA, obliques
Abdomen: KUB, upright abdomen
Hand & fingers: PA, lateral, oblique
Wrist: PA, lateral, oblique
Forearm: AP, lateral
Elbow: AP, lateral
Humerus: AP, lateral
Shoulder: AP, internal & external rotation, y-view
Clavicle: AP, AP axial
Pelvis: AP
Hips: AP, frog leg lateral, cross-table lateral
Femur: AP, lateral
Knee: AP, lateral, obliques
Patella: AP, lateral, sunrise
Tibia-Fibula: AP, lateral
Ankle: AP, lateral, obliques
Calcaneous: Plantodorsal, lateral
Foot & toes: AP, lateral, obliques
Sinuses: Water's, lateral
Skull: AP/PA, lateral
Facial bones: PA, lateral
Nasal bones: Water's, lateral
C-spine: AP, lateral, odontoid, (not trauma), swimmer's (not trauma)
T-spine: AP, lateral, swimmer's (not trauma)
L-spine: AP, lateral, L5-S1 lateral
Any situation deemed an emergency and requiring a limited x-ray machine operator to conduct
procedures not specifically listed above, requires a written order from an individual listed in part 3 of
appendix G and direct supervision from the individual ordering the examination in accordance with
item 1 of subparagraph c of paragraph 2 of subdivision a of subsection 1 of section 33.1-10-06-03.
History: Effective January 1, 2019.

An individual must perform at least three examinations prior to requesting a final competency
evaluation for each of the limited scope examinations listed in appendix I. The three pre-evaluation
examinations should be on actual patients but may be simulated if there is an insufficient number of
patients requiring the procedure during the students clinical competency training period. The
evaluations shall be documented on forms provided by the department. The final competency
evaluation must be on an actual patient. To pass a final competency evaluation, the individual must
receive an acceptable rating in each of the criteria listed below.
1. At a minimum, the following criteria must be evaluated during a procedure and image
competency evaluation involving an actual patient. Simulated procedures need to evaluate
only subdivisions a through k below:
a. Select appropriate film size.
b. Select appropriate technique.
c. Use correct source-to-image distance.
d. Establish proper direction of central ray.
e. Execute proper patient position.
f. Collimate if appropriate.
g. Provide gonadal shielding if appropriate.
h. Use correct film markers.
i. Give proper patient instruction.
j. Place patient information correctly on the film.
k. Complete examination in an acceptable time limit.
l. All anatomical parts included on the film.
m. Correct positioning of anatomical parts.
n. Appropriate contrast.
o. Adequate density.
p. Correct use of right and left markers.
q. Proper accessory markers as needed.
r. No visible motion.
s. Patient information correct and clearly visible.
2. If the individual is unable to demonstrate clinical competence while completing the
requirements for clinical supervision in either subdivision a or b of subsection 2 of appendix H
due to a lack of opportunities to conduct certain procedures, the student shall complete the
three prerequisite examinations using simulation for subdivisions a through k of subsection 1.
Final demonstration of competence in subdivisions a through s of subsection 1 should be

completed as soon as there is a patient requiring the procedure. No individual may perform an
unsupervised procedure for which they have not successfully completed the final
demonstration of competence.
History: Effective January 1, 2019.

Continuing education units (CEUs) are required for all limited x-ray machine operators and general
diagnostic operators as defined by subparagraphs a and b of paragraph 2 of subdivision a of
subsection 1 of section 33.1-10-06-03 of the North Dakota radiological health rules. Continuing
education unit requirements will be associated with a two-year cycle (biennium).
1. General diagnostic operators shall obtain a minimum of 24 CEUs per biennium.
2. Limited x-ray machine operators shall obtain a minimum of 12 CEUs per biennium.
3. Units from one biennium cannot be carried forward or applied to the following biennium.
4. Determining the beginning of a biennium.
a. For limited x-ray machine operators and general diagnostic operators not certified
through an accrediting body, the biennium will begin January 1, 2009.
b. For general diagnostic operators certified through an accrediting body, the biennium will
be defined by the registration requirements through their accrediting body and shall begin
on the first due date following January 1, 2009.
5. Continuing education unit activities must be approved by an accrediting body.
History: Effective January 1, 2019.
