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ANSI/AAMI/ISO 25539-1:2017
Cardiovascular implants -Endovascular devices - Part 1: Endovascular prostheses
Specifies requirements for the evaluation of endovascular systems (prostheses and delivery systems) and requirements with respect to nomenclature, design attributes and information supplied by the manufacturer based upon current medical knowledge. Guidance for the development of in vitro test methods is included in an informative annex to this document.
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Association for the Advancement of Medical Instrumentation [aami]
