Section 1601. General requirements for all diagnostic x-ray systems

In addition to other requirements of this part, 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, operating instructions, and maintenance schedules are observed."

2. 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 0.88 milligray (mGy) air kerma (100 milliroentgen (mR) exposure) in one hour when the x-ray tube is operated at its leakage technique factors. If the maximum rated peak tube potential of the tube housing assembly is greater than the maximum rated peak tube potential for the diagnostic source assembly, positive means shall be provided to limit the maximum x-ray tube potential to that of the diagnostic source assembly. Compliance shall be determined by measurements averaged over an area of 100 square cm with no linear dimension greater than 20 cm.

3. Radiation from components other than the diagnostic source assembly. The radiation emitted by a component other than the diagnostic source assembly shall not exceed an air kerma of 18 microgray (two milliroentgens exposure) in one hour at five cm 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 cm with no linear dimension greater than 20 cm.

4. Beam quality half-value layer (HVL).

a. The HVL of the useful beam for a given x-ray tube potential shall not be less than the values shown in Table 1 (i) under the heading "Specified Dental Systems" for any dental x-ray system designed for use with intraoral image receptors and manufactured after December 1, 1980; (ii) under the heading "I-Other X-Ray Systems" for any dental x-ray system designed for use with intraoral image receptors and manufactured before or on December 1, 1980, and all other x-ray systems subject to this section and manufactured before June 10, 2006; and (iii) under the heading "II-Other X-Ray Systems" for all x-ray systems, except dental x-ray systems designed for use with intraoral image receptors, subject to this section and manufactured on or after June 10, 2006. 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. Positive means shall be provided to ensure that at least the minimum filtration needed to achieve beam quality requirements is in the useful beam during each exposure. In the case of a system, which is to be operated with more than one thickness of filtration, this requirement can be met by a filter interlocked with the kilovoltage selector that will prevent x-ray emissions if the minimum required filtration is not in place.

	TABLE 1
	X-Ray Tube Voltage (kilovolt peak)
	Design Operating Range	Measured Operating Potential	Minimum HVL (mm in Aluminum)
			Specified Dental Systems1	I-Other X-Ray Systems2	II-Other X-Ray Systems3
	Below 51	30	1.5	0.3	0.3
		40	1.5	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
	1 Dental x-ray systems designed for use with intraoral image receptors and manufactured after December 1, 1980. 2 Dental x-ray systems designed for use with intraoral image receptors and manufactured before or on December 1, 1980, and all other x-ray systems subject to this section and manufactured before June 10, 2006. 3 All x-ray systems, except dental x-ray systems designed for use with intraoral image receptors, subject to this section and manufactured on or after June 10, 2006.

b. Optional filtration. Fluoroscopic systems manufactured on or after June 10, 2006, incorporating an x-ray tube or tubes with a continuous output of one kilowatt or more and an anode heat storage capacity of one million heat units or more shall provide the option of adding x-ray filtration to the diagnostic source assembly in addition to the amount needed to meet the half-value layer provisions in Table 1. The selection of this additional x-ray filtration shall be either at the option of the user or automatic as part of the selected mode of operation. A means of indicating which combination of additional filtration is in the x-ray beam shall be provided.

c. Measuring compliance. For capacitor energy storage equipment, compliance shall be determined with the maximum selectable quantity of charge per exposure.

5. Aluminum equivalent of material between patient and image receptor. Except when used in a CT x-ray system, the aluminum equivalent of each of the items listed in Table 2, which are used between the patient and the image receptor, shall not exceed the indicated limits. Compliance shall be determined by x-ray measurements made at a potential of 100 kilovolts peak and with an x-ray beam that has an HVL specified in Table 1 for the potential. This requirement applies to front panel or panels of cassette holders and film changers provided by the manufacturer for patient support or for prevention of foreign object intrusions. It does not apply to screens and their associated mechanical support panels or grids.

	TABLE 2
	Item	Maximum Aluminum Equivalent (mm)
	Front panel(s) of cassette holders (total of all)	1.2
	Film panel(s) of film changer (total of all)	1.2
	Cradle	2.3
	Tabletop, stationary, without articulated joints	1.2
	Tabletop, movable, without articulated joints (including stationary subtop)	1.7
	Tabletop, with radiolucent panel having one articulated joint	1.7
	Tabletop, with radiolucent panel having two or more articulated joints	2.3
	Tabletop, cantilevered	2.3
	Tabletop, radiation therapy simulator	5.0

6. Battery charge indicator. On battery-powered 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.

7. Modification of certified diagnostic x-ray components and systems.

a. Diagnostic x-ray components and systems certified in accordance with 21 CFR Part 1020 shall not be modified such that the component or system fails to comply with any applicable provision of this part.

b. The owner of a diagnostic x-ray system who uses the system in a professional or commercial capacity may modify the system provided the modification does not result in the failure of the system or a component to comply with the applicable requirements of this part. The owner who causes such modification need not submit the reports required by this part, provided the owner records the date and the details of the modification in the system records and maintains this information, and provided the modification of the x-ray system does not result in a failure to comply with this part.

8. 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 which has been selected.

9. 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.

10. Technique indicators.

a. For x-ray equipment capable of displaying technique factors, 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 that are set prior to the exposure shall be indicated.

b. The requirement of subdivision 10 a of this subsection 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.

11. 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.

12. Locks. All position locking, holding, and centering devices on x-ray system components and systems shall function as intended.

13. Mechanical timers. The use of mechanical timers is prohibited.

Historical Notes

Derived from Volume 31, Issue 24, eff. August 27, 2015.

Statutory Authority

§ 32.1-229 of the Code of Virginia.