64E-5.631. Use of Sealed Sources for Diagnosis

The 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 64E-5.612, F.A.C., are met.

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

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

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

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

(5) For isotopes or uses not listed in subsections 64E-5.631(1) through (4), F.A.C., above, the licensee must amend their radioactive materials license.

In order to use isotopes in accordance this Rule, an authorized user must satisfy the training and experience requirements specified in Rule 64E-5.654 or 64E-5.657, F.A.C.

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. History–New 8-25-91, Formerly 10D-91.743, Amended 2-11-10.