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EN ISO 13485:2016/AC:2018 Standard

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  Keywords:

#quality #purposes #regulatory #requirements #systems

  Directive

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

  Last Official Journal reference

Wednesday 14th of April 2021

  Description:

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

  Purpose

Corrigendum for EN ISO 13485:2016

  Publication

Wednesday 25th of March 2020

  Correction

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

  Related Standards

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

EN 45502-2-2:2008

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

EN 45502-2-1:2003

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Active implantable medical devices - Part 2-1: Particular requirements for active implantable medical devices intended to treat br...

EN 45502-1:1997

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