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EN ISO 25539-1:2009 Standard

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  Keywords:

#requirements #design #endovascular #performance #specifies

This standard can be totally or partially supervised by:
  •   EN ISO 25539-1:2009/AC:2011
  •   Directive

    Medical devices Directive (93/42/EEC)

      Last Official Journal reference

    Wednesday 14th of April 2021

      Description:

    Cardiovascular implants - Endovascular devices - Part 1: Endovascular prostheses (ISO 25539-1:2003 including Amd 1:2005)

      Purpose

    This part of ISO 25539 specifies requirements for endovascular prostheses, based upon current medical knowledge. With regard to safety, it gives requirements for intended performance, design attributes, materials, design evaluation, manufacturing, sterilization packaging and information supplied by the manufacturer. It should be considered as a supplement to ISO 14630, which specifies general requirements for the performance of non-active surgical implants.

      Publication

    Friday 17th of November 2017

      Reference

    This standard supersedes the "EN 12006-3:1998 +A1:2009 (EN ISO 25539-1:2008)"

    Anyway is still possible use the "EN 12006-3:1998 +A1:2009 (EN ISO 25539-1:2008)" until March 21st, 2010

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