Nebraska Administrative Code › Topic - HEALTH AND HUMAN SERVICES SYSTEM › Title 180 - CONTROL OF RADIATION › Chapter 6 - DIAGNOSTIC X RAYS IN THE HEALING ARTS › Section 180-6-004 - GENERAL REQUIREMENTS FOR ALL DIAGNOSTIC AND INTERVENTIONAL X-RAY SYSTEMS

Current through June 17, 2024
In 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.