Section 335.8010  Use of a Sealed Source in Remote Afterloader Units, Intravascular Brachytherapy Units, Teletherapy Units or Gamma Stereotactic Radiosurgery Units

A licensee shall use sealed sources in remote afterloader units, intravascular brachytherapy units, teletherapy units or gamma stereotactic radiosurgery units for therapeutic medical uses that are:

a)         Obtained from a person specified in Section 335.30 of this Part, or equivalent U.S. Nuclear Regulatory Commission, Agreement State or Licensing State requirements; or

b)         Approved and used in accordance with the Sealed Source and Device Registry and the manufacturer's instruction manual; or

c)         Used in research in accordance with an active Investigational Device Exemption (IDE) application accepted by the FDA, provided the requirements of Section 335.30 of this Part are met.

(Source:  Amended at 30 Ill. Reg. 9029, effective April 28, 2006)