Standard Practice for Marking Medical Devices and Other Items for Safety in the Magnetic Resonance Environment
|Publication Date:||1 February 2020|
|ICS Code (Medical equipment in general):||11.040.01|
This international standard applies to the practice of marking of items that might be used in the magnetic resonance (MR) environment.
The purpose of this practice is to mark items that might be brought into the MR environment and to recommend information that should be included in the marking.
The standard specifies the permanent marking of items, which are used in an MR environment, by means of terms and icons.
MR image artifacts are not considered to be a performance issue and so are not addressed in this international standard 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, health, and environmental practices and determine the applicability of regulatory limitations prior to use.
This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.