Or. Admin. R. 333-116-0420
Current through Register Vol. 63, No. 8, August 1, 2024
Section 333-116-0420 - Use of Sources for Manual BrachytherapyA licensee must use only brachytherapy sources for therapeutic medical uses:
(1) As approved in the Sealed Source and Device Registry for manual brachytherapy medical use. The manual brachytherapy sources may be used for manual brachytherapy uses that are not explicitly listed in the Sealed Source and Device Registry, but must be used in accordance with the radiation safety conditions and limitations described in the Sealed Source and Device Registry; or(2) In research to deliver therapeutic doses for medical use in accordance with an active Investigational Device Exemption (IDE) application accepted by the Food and Drug Administration and are manufactured, labeled, packaged and distributed under a specific license issued by the U.S. Nuclear Regulatory Commission or an Agreement State provided that the requirements of OAR 333-116-0140 are met.Or. Admin. R. 333-116-0420
HD 1-1991, f. & cert. ef. 1-8-91; PH 3-2003, f. & cert. ef. 3-27-03; PH 31-2004(Temp), f. & cert. ef. 10-8-04 thru 4-5-05; PH 36-2004, f. & cert. ef. 12-1-04; PH 12-2006, f. & cert. ef. 6-16-06; PH 4-2007, f. & cert. ef. 3-1-07; PH 30-2018, minor correction filed 02/01/2018, effective 2/1/2018; PH 81-2021, amend filed 11/19/2021, effective 11/23/2021Statutory/Other Authority: ORS 453.635
Statutes/Other Implemented: ORS 453.605 - 453.807