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EN ISO 13485:2016/AC:2018 Standard

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  Keywords:

#quality #purposes #regulatory #requirements #systems

  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

Wednesday 25th of March 2020

  Correction

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

  Related Standards

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EN ISO 8835-4:2009

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EN ISO 8835-5:2009

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Inhalational anaesthesia systems - Part 5: Anaesthetic ventilators (ISO 8835-5:2004)

EN ISO 9170-1:2008

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Terminal units for medical gas pipeline systems - Part 1: Terminal units for use with compressed medical gases and vacuum (ISO 917...

EN ISO 9170-2:2008

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Terminal units for medical gas pipeline systems - Part 2: Terminal units for anaesthetic gas scavenging systems (ISO 9170-2:2008)

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