MRI Symbols and Terms for MRI Safety |
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For more information on the ASTM Standard visit http://www.astm.org and search for F2503-05.
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The highly anticipated Standard Practice for Marking Medical Devices for Safety in the Magnetic Resonance Environment by American Society for Testing and Materials (ASTM) has arrived.
As recommended by ASTM Intl.; The intent of this practice is to provide needed information about the safety of items in and near MR scanners using a compact and easily recognized set of symbols and terms. The terms MR safe and MR compatible as first defined in 1997 in the FDA draft guidance document, “A Primer on Medical Device Interactions with Magnetic Resonance Imaging Systems,” have been used to describe the safety of devices in and near MR systems. However, there has been a great deal of confusion surrounding this terminology. An incorrect assumption is often made. Users often incorrectly assume that items labeled MR safe or MR compatible are safe or compatible for any MR environment. MR environments vary in terms of magnetic field strength and RF conditions. This new system eliminates much of that confusion.
Products NOT marked with a designation have been tested under the past methods and are currently being re-evaluated under the new ASTM Standards. Products will be updated continually. |