N.M. Admin. Code § 20.3.7.712

Current through Register Vol. 35, No. 21, November 5, 2024

Section 20.3.7.712 - SEALED SOURCES FOR DIAGNOSIS

A. Use of sealed sources for diagnosis. A licensee shall use only sealed sources 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 U.S. Food and Drug Administration provided the requirements of 10 CFR § 35.49(a) are met.

D. Survey instrument. A licensee authorized to use radioactive material as a sealed source for diagnostic purposes shall have available for use a portable radiation survey meter capable of detecting dose rates ranging from 0.1 millirem (1 millisievert) per hour to 1000 millirems (10 millisieverts) per hour. The instrument shall be operable and calibrated in accordance with section Subsection C of 20.3.7.703 NMAC.

N.M. Admin. Code § 20.3.7.712

20.3.7.712 NMAC - Rp, 20 NMAC 3.1.7.711, 4/30/2009, Amended by New Mexico Register, Volume XXXIV, Issue 03, February 14, 2023, eff. 2/14/2023