Section He-P 4035.47 - Use of a Sealed Source in a Remote Afterloader Unit, Teletherapy Unit, or Gamma Stereotactic Radiosurgery UnitA licensee shall use sealed sources in photon emitting remote afterloader units, teletherapy units, or gamma stereotactic radiosurgery units:
(a) As approved in the Sealed Source and Device Registry to deliver therapeutic doses for medical uses, or in research 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; or(b) Approved in the Sealed Source Device Registry to deliver a therapeutic dose for medical use. These devices may be used for:(1) Therapeutic medical treatments that are not explicitly provided for in the Sealed Source and Device Registry, but shall be used in accordance with radiation safety conditions and limitations described in the Sealed Source and Device Registry; or(2) In research 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 4035.47
(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