Standard Practice for Marking Medical Devices and Other Items for Safety in the Magnetic Resonance Environment
|Publication Date:||1 October 2008|
|ICS Code (Medical equipment in general):||11.040.01|
This practice covers the marking of medical devices and other items to indicate their safety in the magnetic resonance (MR) environment.
The purpose of this practice is to (1) recommend that items that may be brought into the MR environment be permanently marked to indicate the MR environment to which a specific item may safely be exposed, and (2) recommend information that should be included in the marking. It is recognized that direct marking on the item is not practical for implants and certain other medical devices. Where direct marking is not practical, this practice recommends that the marking be included in the labeling and on patient information cards (see 7.1).
Image artifact is not considered to be a safety issue and so is not addressed in this practice (see X1.5).
The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.
This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety and health practices and determine the applicability of regulatory limitations prior to use.