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EN ISO 25539-2:2009 Standard

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  Keywords:

#requirements #performance #design #specifies #considered

This standard can be totally or partially supervised by:
  •   EN ISO 25539-2:2009/AC:2011
  •   Directive

    Medical devices Directive (93/42/EEC)

      Last Official Journal reference

    Wednesday 14th of April 2021

      Description:

    Cardiovascular implants - Endovascular devices - Part 2: Vascular stents (ISO 25539-2:2008)

      Purpose

    This part of ISO 25539 specifies requirements for vascular stents, 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 25539-2:2008)"

    Anyway is still possible use the "EN 12006-3:1998 +A1:2009 (EN ISO 25539-2:2008)" until March 21st, 2010

      Related Standards

    EN ISO 10993-6:2009

    Medical devices Directive (93/42/EEC)

    Biological evaluation of medical devices - Part 6: Tests for local effects after implantation (ISO 10993-6:2007)

    EN ISO 10079-2:2009

    Medical devices Directive (93/42/EEC)

    Medical suction equipment - Part 2: Manually powered suction equipment (ISO 10079-2:1999)

    EN ISO 8835-4:2009

    Medical devices Directive (93/42/EEC)

    Inhalational anaesthesia systems - Part 4: Anaesthetic vapour delivery devices (ISO 8835-4:2004)

    EN ISO 9170-2:2008

    Medical devices Directive (93/42/EEC)

    Terminal units for medical gas pipeline systems - Part 2: Terminal units for anaesthetic gas scavenging systems (ISO 9170-2:2008)

    EN ISO 9360-1:2009

    Medical devices Directive (93/42/EEC)

    Anaesthetic and respiratory equipment - Heat and moisture exchangers (HMEs) for humidifying respired gases in humans - Part 1: HME...

    EN ISO 9360-2:2009

    Medical devices Directive (93/42/EEC)

    Anaesthetic and respiratory equipment - Heat and moisture exchangers (HMEs) for humidifying respired gases in humans - Part 2: HME...

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