Florida Administrative Code
64 - DEPARTMENT OF HEALTH
64E - Division of Environmental Health
Chapter 64E-5 - CONTROL OF RADIATION HAZARDS
Section 64E-5.634 - Use of a Sealed Source in a Remote Afterloader Unit, Teletherapy Unit, or Gamma Sterotactic Radiosurgery Unit

Universal Citation: FL Admin Code R 64E-5.634

Current through Reg. 50, No. 249, December 24, 2024

(1) A licensee shall use sealed sources in photon emitting 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 IDE application accepted by the FDA provided the requirements of Rule 64E-5.612, F.A.C. are met.

(2) A licensee shall use sealed sources in photon emitting remote afterloader units for therapeutic medical uses:

(a) As approved in the Sealed Source and Device Registry, or

(b) In research in accordance with an active IDE application accepted by the FDA provided the requirements of Rule 64E-5.612, F.A.C., are met.

(3) A licensee shall use sealed sources in photon emitting teletherapy units for therapeutic medical uses:

(a) As approved in the Sealed Source and Device Registry, or

(b) In research in accordance with an active IDE application accepted by the FDA provided the requirements of Rule 64E-5.612, F.A.C., are met.

Rulemaking Authority 404.022, 404.051, 404.061, 404.071, 404.081, 404.141 FS. Law Implemented 404.022, 404.051(1), (4), (5), (6), (8), (9), (10), (11), 404.061(2), (3), 404.071(1), 404.081, 404.141 FS.

New 8-25-91, Formerly 10D-91.751, Amended 2-11-10.

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