3701:1-58-55 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:

(A) As approved in the Sealed Source and Device Registry; or

(B) 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 3701:1-58-17 of the Administrative Code are met.

Effective: 08/15/2005

R.C. 119.032 review dates: 08/15/2010

Promulgated Under: 119.03

Statutory Authority: 3748.02, 3748.04

Rule Amplifies: 3748.04