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AAMI/ISO 25539-1:2017

AAMI/ISO 25539-1:2017

Cardiovascular implants - Endovascular devices - Part 1: Endovascular prostheses

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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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