Stent Testing

With the recent release of the new Guidance document from the FDA and the publication of the ISO document 25539-1, stent testing has become far more defined. To download FDA's recommendations, visit fda.gov/../guidance/1545.pdf. The most recent versions of the ISO document are available online at www.aami.org .

ISO 25539 covers Endovascular Devices. Part one outlines Endovascular prosthesis and was published in 2003, with an Amendment Document covering test methods published in 2004. Part two covers Vascular Stents. The subcommittee task group is working to submit a draft to the main committee by the next ISO International meeting this Fall. Part three of this document covers Vena Cava Filters.

ASTM international is also working on stent testing standards. There are currently several documents in publication that have been acknowledged by the FDA for submission testing. For a complete list, visit www.ASTM.org . ASTM committee meetings are open to the public and welcome input from interested parties.



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