Section 180-6-004 - GENERAL REQUIREMENTS FOR ALL DIAGNOSTIC AND INTERVENTIONAL X-RAY SYSTEMSIn addition to other requirements of 180 NAC 6-004, all diagnostic and interventional x-ray systems must meet the specifications of 21 CFR § 1020.30.
004.01 FILTRATION CONTROL. X-ray systems that have variable kilovolt peak (kVp) and variable filtration for the useful beam must have a device to link the kilovolt peak (kVp) selector with the filter or filters and must prevent an exposure unless the minimum amount of filtration required in 21 CFR § 1020.30(m) is in the useful beam for the kVp that has been selected.004.02 BEAM LIMITATION. The useful beam must be limited to the area of clinical interest.004.03 MULTIPLE TUBES. When two or more radiographic tubes are controlled by one exposure switch, the tube or tubes which have been selected must be clearly indicated prior to initiation of the exposure. This indication must be on the x-ray control panel and at or near the tube housing assembly that has been selected.004.04 MECHANICAL SUPPORT OF TUBE HEAD. The tube housing assembly supports must be adjusted so that the tube housing assembly will remain stable during the exposure except when the tube housing movement is a designed function of the x-ray system.004.05 MAINTAINING COMPLIANCE. Diagnostic x-ray systems and their associated components used on humans and certified under the Federal X-ray Equipment Performance Standard, 21 CFR Part 1020, must be maintained in compliance with applicable requirements of that standard.004.06 LOCKS. All position locking, holding, and centering devices on x-ray systems components and systems must function as intended.004.07 EQUIPMENT PERFORMANCE EVALUATION. For all radiation generating equipment, except bone densitometry , veterinary, computed tomography (CT), and cone beam computed tomography (CBCT) the registrant must perform, or cause to be performed, tests necessary to insure the proper function of equipment. These tests must be performed every three years. For dental radiation generating equipment, these tests must be performed every five years. The evaluation must include the following measures.004.07(A)TIMER. The accuracy of the timer must meet the manufacturer's specifications. If the manufacturer's specifications are not obtainable, the timer accuracy must be within plus or minus 10% of the indicated time with testing performed at 0.5 second.004.07(B) EXPOSURE REPRODUCIBILITY. When all technique factors are held constant, including control panel selections associated with automatic exposure control systems, the coefficient of variation of exposure for both manual and automatic exposure control systems will not exceed 0.05. This requirement applies to clinically used techniques.004.07(C) KILOVOLT PEAK (kVp). The kilovolt peak (kVp) must meet the manufacturer's specifications. If the manufacturer's specifications are not obtainable, the indicated kilovolt peak must be accurate to within plus or minus 10% of the indicated setting or settings. For dental radiation generating equipment, with fewer than three fixed kilovolt peak (kVp) settings, the machine must be checked at those settings.004.07(D) TUBE STABILITY. The x-ray tube must remain physically stable during exposures. When tubes are designed to move during exposure, the registrant will assure proper and free movement of the radiation generating equipment.004.07(E) COLLIMATION. Field limitation must meet the requirements of 21 CFR § 1020.32(b) for fluoroscopic systems, 21 CFR § 1020.31(d) for radiographic systems, 21 CFR § 1020.31(f)(1), for dental intraoral equipment, or 21 CFR § 1020.31(f)(4) for dental extraoral equipment.004.07(F) CORRECTION OR REPAIR. Any items not meeting the specifications of the tests must be corrected or repaired. Correction or repair must begin within 30 days following the check and must be performed according to a plan developed by the registrant. Correction or repair must be completed 90 days from discovery unless authorized by the Department.004.07(G) IN-AIR EXPOSURE. A measurement of the in-air exposure or exposures at a technique factor or factors for an average adult thickness for the most common procedure or procedures performed.004.07(H) DOSIMETRY SYSTEM. The measurement of the radiation output of an x-ray system must be performed with a calibrated dosimetry system. The calibration of that system must be traceable to a national standard. The dosimetry system must have been calibrated within the preceding two years. During the calendar year the dosimetry system is not calibrated, an intercomparison to a system calibrated within the previous 12 months must be performed.180 Neb. Admin. Code, ch. 6, § 004
Amended effective 11/4/2020