Section He-P 4035.41 - Use of Sources for Manual Brachytherapy A licensee shall use only brachytherapy sources for therapeutic medical use:
(a) As approved in the Sealed Source and Device Registry. The manual brachytherapy sources may be used for manual brachytherapy 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; or(b) In research to deliver therapeutic doses for medical use, in accordance with an active Investigational Device Exemption (IDE) application accepted by the FDA provided the requirements of He-P 4035.15(a) are met.N.H. Admin. Code § He-P 4035.41
(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