La. Admin. Code tit. 33, § XV-747 - Use of Sealed Sources in Teletherapy Units, Remote Afterloader Units, and Gamma Stereotactic Radiosurgery Units

Current through Register Vol. 48, No. 3, March 20, 2022

A. A licensee shall use sealed sources in teletherapy units, photon emitting remote afterloader units, or gamma stereotactic radiosurgery units for therapeutic medical uses:
1. as approved in the Sealed Source and Device Registry; or
2. in research in accordance with an active Investigational Device Exemption (IDE) application accepted by the FDA, provided the requirements of LAC 33:XV.713.A.1 are met.
B. A licensee shall use teletherapy units, photon-emitting remote afterloader 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 shall 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 FDA provided the requirements of LAC 33:XV.713.A.1 are met.

Notes

La. Admin. Code tit. 33, § XV-747
Promulgated by the Department of Environmental Quality, Office of Air Quality and Radiation Protection, Radiation Protection Division, LR 18:34 (January 1992), amended by the Office of Environmental Assessment, Environmental Planning Division, LR 30:1180 (June 2004), Amended by the Office of the Secretary, Legal Affairs and Criminal Investigations Division, LR 471859 (12/1/2021).
AUTHORITY NOTE: Promulgated in accordance with R.S. 30:2001 et seq. and 2104.B.

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