Section 410IAC5-6.1-119. Diagnostic x-ray systems

 

                                (a) Podiatric and veterinary x-ray facilities shall be evaluated at least once each twenty-four (24) months by a diagnostic imaging physicist or x-ray machine inspector approved by the department. Dental x-ray facilities shall be evaluated at least once each thirty-six (36) months by a diagnostic imaging physicist or x-ray machine inspector approved by the department. Mammography facilities shall be evaluated at least once each twelve (12) months by a diagnostic imaging physicist approved by the department. All other diagnostic x-ray systems shall be evaluated at least once each twelve (12) months by a diagnostic imaging physicist or x-ray machine inspector approved by the department. Those x-ray facilities which have been evaluated within sixty (60) days after the end of the interval established in this section will be considered to be in compliance with this section as long as the evaluation occurs in the same calendar year as the date on which reevaluation is required. All diagnostic x-ray systems shall comply with this section.

                                (b) The x-ray control panel containing the main power switch shall bear the warning statement, legible and accessible to view, "WARNING: This x-ray system may be dangerous to patient and operator unless safe exposure factors and operating instructions are observed.".

                                (c) For battery-powered generators, visual means shall be provided on the x-ray control panel to indicate whether the battery is charged adequately for proper operation.

                                (d) Leakage radiation from the diagnostic source assembly measured at a distance of one (1) meter in any direction from the source shall not exceed one hundred (100) mR in one (1) 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 (100) square cm with no linear dimension greater than twenty (20) cm.

                                (e) Radiation emitted by a component other than the diagnostic source assembly shall not exceed two (2) mR in one (1) hour at five (5) cm from any accessible surface of the component when it is operated in an assembled x-ray system under any condition for which it was designed. Compliance shall be determined by measurements averaged over an area of one hundred (100) square cm with no linear dimension greater than twenty (20) cm.

                                (f) The half-value layer of the useful beam for a given x-ray tube voltage shall be no less than the values shown as follows:

TABLE I
Design	Measured	Half-Value Layer
Operating Range	Voltage	Aluminum Equivalent
Below 50 kVp	30 kVp	0.3 mm
	40 kVp	0.4 mm
	49 kVp	0.5 mm
50 to 70 kVp	50 kVp	1.2 mm
	60 kVp	1.3 mm
	70 kVp	1.5 mm
	71 kVp	2.1 mm
	80 kVp	2.3 mm
	90 kVp	2.5 mm
	100 kVp	2.7 mm
	110 kVp	3.0 mm
	120 kVp	3.2 mm
	130 kVp	3.5 mm
	140 kVp	3.8 mm
	150 kVp	4.1 mm

For a kVp not listed in Table I, linear interpolation shall be utilized to determine the minimum acceptable half-value layer. For capacitor energy storage x-ray systems, compliance shall be determined with the maximum charge per exposure assumed to be the kVp. The required minimum aluminum equivalent filtration shall include the filtration contributed by all materials which are always present between the source and the patient. The requirements of this subsection will be considered to have been met if it can be demonstrated that the aluminum equivalent of the total filtration in the primary beam is not less than that shown as follows:

TABLE II
	Total Filtration
Operating Voltage	Aluminum Equivalent
Below 50 kVp	0.5 mm
50 to 70 kVp	1.5 mm
Above 70 kVp	2.5 mm

In addition, there must be compliance with the following:

(1) Beryllium window tubes shall have a minimum of five-tenths (0.5) mm aluminum equivalent filtration permanently installed in the useful beam.

(2) For capacitor energy storage equipment, compliance with this subsection shall be determined with the maximum quantity of charge per exposure.

(3) For 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 shall prevent an exposure unless the minimum filtration required by this subsection is in the useful beam for the kVp which has been selected.

                                (g) Where two (2) or more radiographic tubes are controlled by one (1) 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 and at or near the tube housing assembly which has been selected.

                                (h) The tube housing assembly supports shall be adjusted such that the tube housing assembly will remain stable during an exposure unless the tube housing movement is a designed function of the x-ray system.

                                (i) 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 which are set prior to the exposure shall be indicated. For equipment having fixed technique factors, the requirement in this subsection may be met by placing permanent markings on such equipment. However, the markings shall be visible from the operator's position except in the case of spot films made by the fluoroscopist. (Indiana State Department of Health; 410 IAC 5-6.1-119; filed Oct 29, 1993, 5:00 p.m.: 17 IR 371; readopted filed Jul 11, 2001, 2:23 p.m.: 24 IR 4234; readopted filed May 22, 2007, 1:44 p.m.: 20070613-IR-410070141RFA; readopted filed Sep 11, 2013, 3:19 p.m.: 20131009-IR-410130346RFA)