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Florida Administrative Code (Last Updated: April 18, 2024) |
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64. Department of Health |
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64E. Division of Environmental Health |
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64E-5. Control Of Radiation Hazards |
64E-5.634. Use of a Sealed Source in a Remote Afterloader Unit, Teletherapy Unit, or Gamma Sterotactic Radiosurgery Unit
1(1) A licensee shall use sealed sources in photon emitting gamma stereotactic radiosurgery units for therapeutic medical uses:
19(a) As approved in the Sealed Source and Device Registry; or
30(b) In research in accordance with an active IDE application accepted by the FDA provided the requirements of Rule 4964E-5.612, 50F.A.C. are met.
53(2) A licensee shall use sealed sources in photon emitting remote afterloader units for therapeutic medical uses:
70(a) As approved in the Sealed Source and Device Registry; or
81(b) In research in accordance with an active IDE application accepted by the FDA provided the requirements of Rule 10064E-5.612, 101F.A.C., are met.
104(3) A licensee shall use sealed sources in photon emitting teletherapy units for therapeutic medical uses:
120(a) As approved in the Sealed Source and Device Registry; or
131(b) In research in accordance with an active IDE application accepted by the FDA provided the requirements of Rule 15064E-5.612, 151F.A.C., are met.
154Rulemaking Authority 156404.022, 157404.051, 158404.061, 159404.071, 160404.081, 161404.141 FS. 163Law Implemented 165404.022, 166404.051(1), 167(4), (5), (6), (8), (9), (10), (11), 174404.061(2), 175(3), 176404.071(1), 177404.081, 178404.141 FS. 180History–New 8-25-91, Formerly 10D-91.751, Amended 2-11-10.
