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Full Description

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.
 

Document History

  1. AAMI/ISO 25539-1:2017

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    Cardiovascular implants - Endovascular devices - Part 1: Endovascular prostheses

    • Most Recent
  2. AAMI/ISO 25539-1:2003/A1:2005/(R)2009


    Cardiovascular implants - Endovascular devices - Part 1: Endovascular prostheses, Amendment 1: Test methods

    • Historical Version
  3. AAMI/ISO 25539-1:2003/(R)2009


    Cardiovascular implants - Endovascular devices - Part 1: Endovascular prostheses

    • Historical Version