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EN ISO 13485:2016/AC:2016 Standard

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  Keywords:

#quality #purposes #regulatory #requirements #systems

  Directive

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

  Last Official Journal reference

Thursday 15th of April 2021

  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This standard has been withdrawn on 2021-09-30

  Correction

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

  Related Standards

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In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 1: Terms, definitions and genera...

EN 14254:2004

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In vitro diagnostic medical devices - Single-use receptacles for the collection of specimens, other than blood, from humans

EN 14820:2004

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Single-use containers for human venous blood specimen collection

EN ISO 14937:2009

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

Sterilization of health care products - General requirements for characterization of a sterilizing agent and the development, vali...

EN ISO 14971:2012

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

Medical devices - Application of risk management to medical devices (ISO 14971:2007, Corrected version 2007-10-01)

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