180 NAC 7-065. USE OF SEALED SOURCES FOR DIAGNOSIS

065. USE OF SEALED SOURCES FOR DIAGNOSIS. 065.01 SEALED SOURCES NOT IN MEDICAL DEVICES. A licensee must use only sealed sources that are not in medical devices for diagnostic medical uses if the sealed sources are approved in the Sealed Source and Device Registry for diagnostic medicine. The sealed sources may be used for diagnostic medical uses that are not explicitly listed in the Sealed Source and Device Registry but must be used according to the radiation safety conditions and limitations described in the Sealed Source and Device Registry. 065.02 MEDICAL DEVICES CONTAINING SEALED SOURCES. A licensee must only use medical devices containing sealed sources for diagnostic medical uses if both the sealed sources and medical devices are approved in the Sealed Source and Device Registry for diagnostic medical uses. The diagnostic medical devices may be used for diagnostic medical uses that are not explicitly listed in the Sealed Source and Device Registry but must be used according to the radiation safety conditions and limitations described in the Sealed Source and Device Registry. 065.03 SEALED SOURCES AND DEVICES USED IN RESEARCH. Sealed sources and devices for diagnostic medical uses may be used in research according to an active Investigational Device Exemption (IDE) application accepted by the FDA provided the requirements of 180 NAC 7-021(A) are met.