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EN ISO 13485:2016/AC:2016 Standard

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  Keywords:

#quality #purposes #regulatory #requirements #systems

This standard is superseeded by:
  •   EN ISO 13485:2016/AC:2018
  •   Directive

    Medical devices Directive (93/42/EEC)

      Last Official Journal reference

    Wednesday 25th of March 2020

      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

      Cessation

    This standard will be withdrawn on 2021-09-30

      Correction

    This standard is a correction for "EN ISO 13485:2016"

      Related Standards

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    EN ISO 25539-1:2009

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    EN ISO 23328-2:2009

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    Breathing system filters for anaesthetic and respiratory use - Part 2: Non-filtration aspects (ISO 23328-2:2002)

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