1. (1) Electronic brachytherapy devices shall be exempt from the requirements in OAR 333-123-0025.

   1. (a) An electronic brachytherapy device that does not meet the requirements of this rule shall not be used for irradiation of patients; and
   2. (b) An electronic brachytherapy device shall only be utilized for human use applications specifically approved by the U.S. Food and Drug Administration (FDA) unless participating in a research study approved by the Authority.
2. (2) Each facility location authorized to use an electronic brachytherapy device shall possess calibrated portable radiation measurement survey instrument capable of measuring dose rates over the range 10 μSv (1 mrem) per hour to 10 mSv (1000 mrem) per hour. The survey instrument(s) shall be operable and calibrated in accordance with OAR 333-123-0010 for the applicable electronic brachytherapy source energy.

Statutory/Other Authority

ORS 453.605 - 453.807

Statutes/Other Implemented

ORS 453.605 - 453.807

History

PH 4-2013, f. & cert. ef. 1-29-13