Okla. Admin. Code § 310:281-11-12

Current through Vol. 42, No. 6, December 2, 2024

Section 310:281-11-12 - General requirements for all human diagnostic x-ray systems

(a)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.

(b)Leakage radiation from the diagnostic x-ray tube assembly. The leakage radiation from the diagnostic x-ray tube assembly measured at a distance of 1 meter in any direction from the x-ray tube assembly shall not exceed 100 milliroentgens in 1 hour when the x-ray tube is operated at its leakage technique factors. Measurement is averaged over an area of 100 square centimeters with no linear dimension greater than 20 centimeters.

(c)Radiation from components other than the diagnostic x-ray tube assembly. The radiation emitted by a component other than the diagnostic x-ray tube assembly cannot exceed 2 milliroentgens in 1 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. Measurement is averaged over an area of 100 square centimeters with no linear dimension greater than 20 centimeters.

(d)Beam quality.

(1)Half-value layer (HVL).

(A) The half-value layer of the useful beam for a given x-ray tube potential shall not be less than the values shown below. If it is necessary to determine such half-value layer at an x-ray tube potential which is not listed in the following table, linear interpolation may be made. Half-value layer measurements shall be made at no less than 90 percent maximum rated potential or 80 kVp, whichever is lower for the unit.

(i) the half-value layer for the selected tube potential of 30 kVp is 0.3 mm of aluminum; (terminology and units listed below are the same listed here);

(ii) 40 kVp is 0.4

(iii) 50 kVp is 0.5

(iv) 51 kVp is 1.2

(v) 60 kVp is 1.3

(vi) 70 kVp is 1.5

(vii) 71 kVp is 2.1

(viii) 80 kVp is 2.3

(ix) 90 kVp is 2.5

(x) 100 kVp is 2.7

(xi) 110 kVp is 3.0

(xii) 120 kVp is 3.2

(xiii) 130 kVp is 3.5

(xiv) 140 kVp is 3.8 and

(xv) 150 kVp is 4.1

(B) In addition to the requirements of 310:281-11-12(d)(1)(A)(i), all intraoral dental radiographic systems manufactured on or after December 1, 1980, shall have a minimum half-value layer not less than 1.5 millimeters aluminum equivalent filtration permanently installed in the useful beam.

(C) For capacitor energy storage equipment, compliance with the requirements of 310:281-11-12(d) is determined with the maximum quantity of charge per exposure.

(D) The required minimal aluminum equivalent filtration includes the filtration contributed by all materials which are always present between the source and the patient.

(2)Filtration controls. For diagnostic x-ray systems which have variable kVp and variable filtration for the useful beam, a device shall link the kVp selector with the filters and prevent an exposure unless the minimum amount of filtration as stated in 310:281-11-12(d)(1) is in the useful beam for the given kVp which has been selected.

(e)Multiple tubes. Where two or more diagnostic x-ray 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.

(f)Technique and exposure indicators.

(1) The system shall display the selected exposure factors before the exposure begins.

(2) The requirement of 310:281-11-12(f)(1) may be met by permanent markings on equipment having fixed technique factors.

(3) The x-ray control shall provide visual indication of the production of x-rays.

(g)Certified diagnostic x-ray systems. In addition to the requirements of these rules, the permittee shall not make, nor cause to be made, any modification of components or installations of components certified pursuant to U.S. Food and Drug Administration Regulation 21 CFR 1020, "Performance Standards for Ionizing Radiation Emitting Products," in any manner that could cause the installations or the components to fail to meet the requirements of the applicable parts of the standards specified in 21 CFR 1020, except where a variance has been granted by the Director, Center for Devices and Radiological Health, Food and Drug Administration.

Okla. Admin. Code § 310:281-11-12

Added at 8 Ok Reg 3503, eff 8-15-91 (emergency); Added at 9 Ok Reg 1643, eff 5-29-92; Amended at 21 Ok Reg 1037, eff 5-13-04

Amended by Oklahoma Register, Volume 38, Issue 24, September 1, 2021, eff. 9/11/2021