North Dakota Administrative Code › 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 › Section 33.1-10-06-04 - General requirements for all diagnostic x-ray systems

Current through Supplement No. 393, July, 2024
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.
TABLE I
Half-Value Layer in Millimeters
							 Aluminum
Design Operating Range (Kilovolts Peak)
Measured Potential (Kilovolts Peak)
Dental Intraoral Manufactured Before Aug. 1, 1974,
							 and on or After Dec. 1, 1980
Diagnostic X-Ray Systems Manufactured Prior to June
							 10, 2006
Diagnostic X-Ray Systems Manufactured on or After
							 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.
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