Tag: Cardiovascular implants – Endovascular devices – Part 2: Vascular stents

New ISO 25539-2 2012 Edition updates the International Standard on Cardiovascular implants – Endovascular devices – Part 2: Vascular stents

ISO 25539-2:2012, “Cardiovascular implants – Endovascular devices – Part 2: Vascular stents,” has just been released and is available now from Document Center Inc.  The 97-page standard specifies requirements for vascular stents, based upon current medical knowledge.  It is part of a three document series.

With regard to safety, ISO 25539-2 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.

This second edition cancels and replaces the first edition (ISO 25539-2:2008). This minor revision updates the normative references and provides minor editorial changes to Clause 8 and Annex D for clarification.

Here’s a list of the complete 25539 series:

  • ISO 25539-1, Cardiovascular implants – Endovascular devices – Part 1: Endovascular prostheses
  • ISO 25539-2, Cardiovascular implants – Endovascular devices – Part 2: Vascular stents
  • ISO 25539-3, Cardiovascular implants – Endovascular devices – Part 3: Vena cava filters

FYI: ISO/TS 15539 serves as a rationale for the requirements of this part of ISO 25539.  Technical Specification ISO/TS 15539 was developed by first identifying the design requirements for these devices and listing the potential device and clinical failure modes. Tests were then identified to address each of the failure modes. The requirements provided in ISO 25539-2 are based on that assessment.

This document has been adopted by the European Union as EN ISO 25539-2.  We normally provide the document in the official English language Edition (BS EN ISO 25539-2 2012 Edition).

All current and many obsolete ISO standards can be purchased online in both paper and pdf format from Document Center’s website, www.document-center.com.  Or consider contacting us by phone (650-591-7600), fax (650-591-7617) or email (info@document-center.com).  Territorial restrictions may apply.