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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This standard has been withdrawn on 2021-09-30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

EN 556-1:2001

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

Sterilization of medical devices - Requirements for medical devices to be designated "STERILE" - Part 1: Requirements for terminal...

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)

EN ISO 13485:2016

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 11607-2:2020

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

Packaging for terminally sterilized medical devices - Part 2: Validation requirements for forming, sealing and assembly processes ...

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)

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