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EN ISO 13485:2016 Standard

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  Keywords:

#quality #purposes #regulatory #requirements #systems

This standard can be totally or partially supervised by:
  •   EN ISO 13485:2016/AC:2016
  •   Directive

    Active implantable medical devices Directive (90/385/EEC)

      Last Official Journal reference

    Friday 17th of November 2017

      Description:

    Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2016)

      Purpose

    Corrigendum for EN ISO 13485:2016

      Publication

    Friday 17th of November 2017

      Reference

    This standard superseed the "EN ISO 13485:2012".

    Anyway is still possible use the "EN ISO 13485:2012" until March 31st, 2019

      Related Standards

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    EN ISO 13408-5:2011

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    Aseptic processing of health care products - Part 5: Sterilization in place (ISO 13408-5:2006)

    EN 60601-1:2006/AC:2010

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    Medical electrical equipment - Part 1: General requirements for basic safety and essential performanceIEC 60601-1:2005

    EN 60601-1:2006

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    Medical electrical equipment - Part 1: General requirements for basic safety and essential performanceIEC 60601-1:2005

    EN 45502-2-3:2010

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    Active implantable medical devices - Part 2-3: Particular requirements for cochlear and auditory brainstem implant systems

    EN 45502-2-2:2008/AC:2009

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    Active implantable medical devices - Part 2-2: Particular requirements for active implantable medical devices intended to treat ta...

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