64E-5.631. Use of Sealed Sources for Diagnosis  


Effective on Thursday, February 11, 2010
  • 1The licensee is allowed to use the sealed sources listed below, provided they are approved by and used as specified in, the Sealed Source and Device Registry, for diagnostic medical uses, or in research in accordance with an active IDE application accepted by the FDA and the requirements of Rule 5164E-5.612, 52F.A.C., are met.

    55(1) Iodine 125 as a sealed source in a device for bone mineral analysis;

    69(2) Iodine 125 as a sealed source in a portable device for imaging;

    82(3) Gadolinium 153 as a sealed source in a device for bone mineral analysis;

    96(4) Americium 241 as a sealed source in a device for bone mineral analysis; or

    111(5) For isotopes or uses not listed in subsections 12064E-5.631(1) 121through (4), F.A.C., above, the licensee must amend their radioactive materials license.

    133In order to use isotopes in accordance this Rule, an 143authorized user must satisfy the training and experience requirements specified in Rule 15564E-5.654 156or 15764E-5.657, 158F.A.C.

    159Rulemaking Authority 161404.022, 162404.051, 163404.061, 164404.071, 165404.081, 166404.141 FS. 168Law Implemented 170404.022, 171404.051(1), 172(4), (5), (6), (8), (9), (10), (11), 179404.061(2), 180(3), 181404.071(1), 182404.081, 183404.141 FS. 185History–New 8-25-91, Formerly 10D-91.743, Amended 2-11-10.

     

Rulemaking Events:

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