ASTM F2503, “Standard Practice for Marking Medical Devices and Other Items for Safety in the Magnetic Resonance Environment,” has just received a major revision release. It replaces the ASTM F2503 – 08, which is now obsolete. You can purchase the new 2013 Edition as a paper document or a pdf download. And a Redline Edition is available too.
You’ll find the new standard practice is now 9 pages long, in comparison to the 2008 Edition’s 7 pages. Most of the added text is in the informative Appendix “X1, Rationale.” The changes to the ASTM F2503 were made in order to harmonize this ASTM standard with the referenced IEC documents (particularly IEC 60601-2-33, which was recently amended as well).
The ASTM F2503 itself applies to the practice of marking medical devices that can be used in the magnetic resonance (MR) environment. These markings are permanent, with precise definition of meaning. Revisions to the standard over the years have all strived to reduce the initial confusion that was the result of historical definitions in the FDA draft guidance from 1997, “A Primer on Medical Device Interactions with Magnetic Resonance Imaging Systems.”
In that draft document, there were only 2 levels of labeling: MR safe and MR compatible. Turns out that there are a number of different MR environments. So not only was a label needed, but also a definition of the specific MR environment for which it applied. So now the standard has a third level of safety, MR Conditional, as well as the MR Unsafe marking.
If you need this ASTM F2503-2013 standard, head off to the Document Center web store at www.document-center.com. There you’ll find not only all current ASTM standards, but many obsolete revisions as well. Document Center has been selling the ASTM standards under license agreement since the 1980’s and has an extensive collection of these documents. Or you are welcome to contact us by phone (650-591-7600), fax (650-591-7617) or email (info@document-center.com).
