Ohio Administrative Code
Title 3701:1 - Radiation Control
Chapter 3701:1-58 - Medical Use of Radioactive Materials
Section 3701:1-58-53 - Use of sealed sources and medical devices for diagnosis
Current through all regulations passed and filed through March 18, 2024
(A) A licensee must use only sealed sources that are not in medical devices for diagnostic medical uses if the sealed sources are approved in the sealed source and device registry for diagnostic medicine. The sealed sources may be used for diagnostic medical uses that are not explicitly listed in the sealed source and device registry but must be used in accordance with the radiation safety conditions and limitations described in the sealed source and device registry.
(B) A licensee must only use medical devices containing sealed sources for diagnostic medical uses if both the sealed sources and medical devices are approved in the sealed source and device registry for diagnostic medical uses. The diagnostic medical devices may be used for diagnostic medical uses that are not explicitly listed in the sealed source and device registry but must be used in accordance with the radiation safety conditions and limitations described in the sealed source and device registry.
(C) Sealed sources and devices for diagnostic medical uses may be used in research in accordance with an active investigational device exemption (IDE) application accepted by the United States food and drug administration provided the requirements of paragraph (A) of rule 3701:1-58-17 of the Administrative Code are met.
Replaces: 3701:1-58-53
