Section 0400-20-06-.09 - APPENDIX AExcerpt from Bureau of Radiological Health Standards for Certified Diagnostic X-ray Equipment. See subpart (2)(a)14.(i) and part (3)(q)1. of Rule 0400-20-06-.05.
(1) Manufacturers of x-ray equipment shall provide for purchaser and, upon request, to others at a cost not to exceed the cost of publication and distribution, manuals or instruction sheets which shall include the following technical and safety information: (a) All x-ray equipment. For x-ray equipment to which this chapter and 21 C.F.R. §§ 1020.31 and 1020.32 are applicable, there shall be provided:
1. Adequate instructions concerning any radiological safety procedures and precautions that may be necessary because of unique features of the equipment; and2. A schedule of the maintenance necessary to keep the equipment in compliance with this chapter and 21 C.F.R. §§ 1020.31 and 1020.32.(b) Tube housing assemblies. For each tube housing assembly, there shall be provided:
1. Statements of the maximum rated peak tube potential, leakage technique factors, the minimum filtration permanently in the useful beam expressed as millimeters of aluminum equivalent, and the peak tube potential at which the aluminum equivalent was obtained;2. Cooling curves for the anode and tube housing; and3. Tube rating charts. If the tube is designed to operate from different types of x-ray high voltage generators (such as single-phase self-rectified, single phase half-wave rectified, single-phase full-wave rectified, three-phase 6 pulse, three-phase 12 pulse, constant potential, capacitor energy storage) or under modes of operation such as alternate focal spot sizes or speeds of anode rotation which affect its rating, specific identification of the difference in ratings shall be noted.
(c) X-ray controls and generators. For the x-ray control and associated x-ray high-voltage generator, there shall be provided:
1. A statement of the rated line voltage and the range of line-voltage regulation for operation at maximum line current;2. A statement of the maximum line current of the x-ray system based on the maximum input voltage and current characteristics of the tube housing assembly compatible with rated output voltage and rated output current characteristics, x-ray control and associated high-voltage generator. If the rated input voltage and current characteristics of the tube housing assembly are not known by the manufacturer of the x-ray control and associated high-voltage generator, he shall provide necessary information to allow the purchaser to determine the maximum line current for his particular tube housing assembly(s);3. A statement of the technique factors that constitute the maximum line current condition described in part 2. of this subparagraph;4. In the case of battery-powered generators, a specification of the minimum state of charge necessary for operation.5. Generator rating and duty cycle;6. A statement of the maximum deviation from the indication given by labeled control settings and/or meters during any exposure when the equipment is connected to a power supply as described in accordance with this paragraph. In the case of fixed technique factors, the maximum deviation from the nominal fixed value of each factor shall be stated; and7. A statement defining the measurement basis (or bases) upon which the exposure time, peak potential, tube current, and/or other technique factors are stated pursuant to parts 3. and 6. of this subparagraph.(d) Variable-aperture beam-limiting device. For each variable-aperture beam-limiting device, there shall be provided:
1. Specifications of tube housing assemblies for which the device is designed or is compatible with respect to the requirements of this Chapter and 21 CFR 1020.31 (d) and (e); and2. A statement including the minimum aluminum equivalent of that part of the device through which the useful beam passes and including the x-ray tube potential at which the aluminum equivalent was obtained. When 2 or more filters are provided as part of the device, the statement shall include the aluminum equivalent of each filter.Tenn. Comp. R. & Regs. 0400-20-06-.09
Original rule filed February 22, 2012; effective May 22, 2012. Amendments filed December 4, 2023; effective 3/3/2024.Authority: T.C.A. §§ 4-5-201, et seq.; 68-202-101, et seq.; and 68-202-201, et seq.