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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This standard has been withdrawn on 2021-09-30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 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)

EN 13641:2002

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

Elimination or reduction of risk of infection related to in vitro diagnostic reagents

EN ISO 13408-3:2011

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

Aseptic processing of health care products - Part 3: Lyophilization (ISO 13408-3:2006)

EN ISO 13408-4:2011

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

Aseptic processing of health care products - Part 4: Clean-in-place technologies (ISO 13408-4:2005)

EN ISO 18113-3:2011

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

In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 3: In vitro diagnostic instrumen...

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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