Use of a sealed source in a remote afterloader unit, teletherapy unit, or gamma stereotactic radiosurgery unit.
A licensee shall use sealed sources in photon emitting remote
afterloader units, teletherapy units, or gamma stereotactic radiosurgery units
for therapeutic medical uses:
approved in the Sealed Source and Device Registry; or
In research in accordance with an active
investigational device exemption application accepted by the United States food
and drug administration provided the requirements of paragraph (A) of rule
of the Administrative Code are met.
Five Year Review (FYR) Dates:
Prior Effective Dates:
Prior History: (R.C.
119.032 review dates:
Prior Effective Dates: 8/15/2005