Section He-P 4035.39 - Use of Sealed Sources and Medical Devices for Diagnosis 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.N.H. Admin. Code § He-P 4035.39
(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
Amended by Volume XXXV, Number 32 Filed August 13, 2015, Proposed by #10897, Effective 7/22/2015, Expires1/18/2016.Amended by Volume XXXVI Number 01, Filed January 7, 2016, Proposed by #11011, Effective 1/15/2016, Expires 1/15/2026.Amended by Volume XL Number 24, Filed June 11, 2020, Proposed by #13048, Effective 6/2/2020, Expires 6/2/2030.Amended by Volume XLII Number 45, Filed November 10, 2022, Proposed by #13473, Effective 10/25/2022, Expires 10/25/2032