Minn. R. agency 144, ch. 4731, MEDICAL USE OF RADIOACTIVE MATERIAL, pt. 4731.4450 - USE OF BRACHYTHERAPY SOURCES
A licensee must use only brachytherapy sources:
A. 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
B.
in research to deliver therapeutic doses for medical use, according to an
active investigational device exemption application accepted by the Food and
Drug Administration, provided the requirements of part 4731.4410, item A, are
met.
Notes
Statutory Authority: MS s 144.1202; 144.1203
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