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ANSI/AAMI/ISO 25539-2:2012
Cardiovascular implants - Endovascular devices - Part 2: Vascular stents
Specifies requirements for vascular stents, based upon current medical knowledge. With regard to safety, it gives requirements for intended performance, design attributes, materials, design evaluation, manufacturing, sterilization, packaging and information supplied by the manufacturer
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Association for the Advancement of Medical Instrumentation [aami]