ANSI/AAMI/ISO 25539-1:2017

ANSI/AAMI/ISO 25539-1:2017

Cardiovascular implants— Endovascular devices—Part 1: Endovascular prostheses

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Details

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. Annex 2

Additional Info

Author Association for the Advancement of Medical Instrumentation (AAMI)
Published by AAMI
Document type Standard
Theme Implants & Artificial Organs
Keyword ANSI/AAMI/ISO 25539-1:2017