Ohio Admin. Code 3701:1-58-55 - Use of a sealed source in a remote afterloader unit, teletherapy unit, or gamma stereotactic radiosurgery unit
(A)
A licensee must
only use sealed sources:
(1)
Approved and as provided for in the sealed source and
device registry in photon emitting remote afterloader units, teletherapy units,
or gamma stereotactic radiosurgery units to deliver therapeutic doses for
medical uses; or
(2)
In research involving photon-emitting remote
afterloader units, teletherapy units, or gamma stereotactic radiosurgery units
in accordance with an active investigational device exemption (IDE) application
accepted by the United States food and drug administration provided the
requirements of paragraph (A) of rule
3701:1-58-17
of the Administrative Code are met.
(B)
A licensee must
use photon-emitting remote afterloader units, teletherapy units, or gamma
stereotactic radiosurgery units:
(1)
Approved in the sealed source and device registry to
deliver a therapeutic dose for medical use. These devices may be used for
therapeutic medical treatments that are not explicitly provided for in the
sealed source and device registry, but must 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 United
States food and drug administration provided the requirements of paragraph (A)
of rule
3701:1-58-17
of the Administrative Code are met.
Replaces: 3701:1-58-55
Notes
Promulgated Under: 119.03
Statutory Authority: 3748.02, 3748.04
Rule Amplifies: 3748.04
Prior Effective Dates: 08/15/2005
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