New Hampshire Code of Administrative Rules
He - Department of Health and Human Services
Subtitle He-P - Former Division of Public Health Services
Chapter He-P 4000 - NEW HAMPSHIRE RULES FOR THE CONTROL OF RADIATION
Part He-P 4035 - USE OF RADIONUCLIDES IN THE HEALING ARTS
Section He-P 4035.39 - Use of Sealed Sources and Medical Devices for Diagnosis
Current through Register No. 40, October 3, 2024
A licensee shall use only:
(a) 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 shall be used in accordance with the radiation safety conditions and limitations described in the Sealed Source and Device Registry;
(b) 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 explicitly listed in the Sealed Source and Device Registry but shall be used in accordance with the radiation safety conditions and limitations described in the Sealed Source and Device Registry; and
(c) Sealed sources and devices for diagnostic medical uses in research in accordance with an active Investigational Device Exemption (IDE) application accepted by the U.S. Food and Drug Administration provided the requirements of He-P 4035.15(a) are met.
(See Revision Note at part heading for He-P 4035) #6942, eff 2-1-99; ss by #8800, INTERIM, eff 2-1-07, EXPIRED: 7-31-07
New. #8959, eff 8-7-07