La. Admin. Code tit. 33 § XV-604

Current through Register Vol. 50, No. 11, November 20, 2024
Section XV-604 - General Requirements for All Diagnostic X-Ray Systems
A. In addition to other requirements of this Chapter, all diagnostic X-ray systems shall meet the following requirements.
1. Warning Label
a. On systems manufactured on or before June 10, 2006, 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."
b. On systems manufactured after June 10, 2006, 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, operating instructions, and maintenance schedules 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 1 meter in any direction from the source shall not exceed 100 milliroentgens (25.8 [MICRO]C/kg) 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 100 square centimeters with no linear dimension greater than 20 centimeters. If leakage technique factors cannot be set on the control panel, then compliance shall be determined by measuring leakage at maximum kVp and an appropriate mAs.
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 2 milliroentgens (0.516 [MICRO]C/kg) in one hour at 5 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 100 square centimeters with no linear dimension greater than 20 centimeters.
5. Beam Quality
a. Half-Value Layer
i. The half-value layer of the useful beam for a given X-ray tube potential shall not be less than the values shown in Table 1 of this Chapter. If it is necessary to determine such half-value layer at an X-ray tube potential that is not listed in Table 1, linear interpolation or extrapolation may be made.

Table 1

Design Operating Range System

Measured Potential (kVp)

Dental Intraoral Manufactured before 8/1/74 and on or before 12/1/80

All Other Diagnostic X-Ray Half-Value Layer (mm of Aluminum)

Below 51

30

N/A

0.3

40

N/A

0.4

50

1.5

0.5

51 to 70

51

1.5

1.2

60

1.5

1.3

70

1.5

1.5

Above 70

71

2.1

2.1

80

2.3

2.3

90

2.5

2.5

100

2.7

2.7

110

3.0

3.0

120

3.2

3.2

130

3.5

3.5

140

3.8

3.8

150

4.1

4.1

ii. For capacitor energy storage equipment, compliance with the requirements of LAC 33:XV.604.A.5 shall be determined with the maximum quantity of charge per exposure. This will be deemed to have been met if a mAs of 5-10 has been used.
iii. The required minimal half-value layer of the useful beam shall include the filtration contributed by all materials that are permanently between the source and the patient, e.g., a tabletop when the tube is mounted "under the table" and inherent filtration of the tube.
b. Filtration Controls. For X-ray systems that have variable kVp and variable filtration for the useful beam, a device shall link the kVp selector with the filter(s) and shall prevent an exposure unless the minimum amount of filtration required by LAC 33:XV.604.A.5.a is in the useful beam for the given kVp that has been selected.
6. Multiple Tubes. Where two or more radiographic tubes are controlled by one exposure switch, the tube or tubes that 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 that 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. If automatic exposure controls are used, the technique factors set prior to the exposure shall be indicated.
b. The requirement of LAC 33:XV.604.A.8.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.
c. The accuracy of the indicated kilovoltage peak (kVp) shall meet manufacturer specifications. In the absence of a manufacturer specification, kVp accuracy shall be within +/- 10 percent.
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 shall be maintained in compliance with applicable requirements of that standard.

La. Admin. Code tit. 33, § XV-604

Promulgated by the Department of Environmental Quality, Nuclear Energy Division, LR 13:569 (October 1987), amended by the Office of Air Quality and Radiation Protection, Radiation Protection Division, LR 19:1421 (November 1993), Amended by the Office of the Secretary, Legal Affairs and Criminal Investigations Division, LR 482935 (12/1/2022).
AUTHORITY NOTE: Promulgated in accordance with R.S. 30:2001 et seq. and 2104.B.