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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

    In vitro diagnostic medical devices Directive (98/79/EC)

      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 13408-4:2011

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    Aseptic processing of health care products - Part 4: Clean-in-place technologies (ISO 13408-4:2005)

    EN ISO 13408-3:2011

    In vitro diagnostic medical devices Directive (98/79/EC)

    Aseptic processing of health care products - Part 3: Lyophilization (ISO 13408-3:2006)

    EN ISO 13408-2:2011

    In vitro diagnostic medical devices Directive (98/79/EC)

    Aseptic processing of health care products - Part 2: Filtration (ISO 13408-2:2003)

    EN ISO 13408-1:2015

    In vitro diagnostic medical devices Directive (98/79/EC)

    Aseptic processing of health care products - Part 1: General requirements (ISO 13408-1:2008, including Amd 1:2013)

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