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About This Item

 

Full Description

This document specifies requirements for the evaluation of stent systems (vascular stents 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 Annex D. This document is supplemental to ISO 14630, which specifies general requirements for the performance of non-active surgical implants.

All current amendments available at time of purchase are included with the purchase of this document.
 

Document History

  1. BS EN ISO 25539-2:2020

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    Cardiovascular implants. Endovascular devices-Vascular stents

    • Most Recent
  2. BS EN ISO 25539-2:2012


    Cardiovascular implants. Endovascular devices-Vascular stents

    • Historical Version
  3. BS EN ISO 25539-2:2009


    Cardiovascular implants. Endovascular devices-Vascular stents

    • Historical Version
  4. BS EN 12006-3:1998+A1:2009


    Non active surgical implants. Particular requirements for cardiac and vascular implants-Endovascular devices

    • Historical Version
  5. BS EN ISO 25539-2:2008


    Cardiovascular implants. Endovascular devices-Vascular stents

    • Historical Version
  6. BS EN 14299:2004


    Non-active surgical implants. Particular requirements for cardiac and vascular implants. Specific requirements for arterial stents

    • Historical Version