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EN ISO 13485:2016 Standard

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  Keywords:

#quality #purposes #regulatory #requirements #systems

This standard is superseeded by:
  •   EN ISO 13485:2016/AC:2018
  • This standard can be totally or partially supervised by:
  •   EN ISO 13485:2016/AC:2016
  •   EN ISO 13485:2016/AC:2018
  •   Directive

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

      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

      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

    EN ISO 15197:2015

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

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    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 13485:2016/AC:2016

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

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

    EN ISO 13408-7:2015

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

    Aseptic processing of health care products - Part 7: Alternative processes for medical devices and combination products (ISO 13408...

    EN ISO 13408-6:2011

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

    Aseptic processing of health care products - Part 6: Isolator systems (ISO 13408-6:2005)

    EN ISO 13408-5:2011

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

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

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