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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

EN ISO 13408-4:2011

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

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

EN ISO 14971:2012

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

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

EN ISO 13408-6:2011

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

Aseptic processing of health care products - Part 6: Isolator systems (ISO 13408-6:2005)

EN ISO 13408-7:2015

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

Aseptic processing of health care products - Part 7: Alternative processes for medical devices and combination products (ISO 13408...

EN ISO 13485:2016

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

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

EN ISO 25424:2019

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

Sterilization of health care products - Low temperature steam and formaldehyde - Requirements for development, validation and rout...

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