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EN ISO 10993-1:2009/AC:2010 Standard

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  Keywords:

#corrigendum #process #management #risk #testing

  Directive

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

  Last Official Journal reference

Wednesday 14th of April 2021

  Description:

Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process (ISO 10993-1:2009)

  Purpose

Corrigendum to EN ISO 10993-1:2009.

  Publication

Friday 17th of November 2017

  Correction

This standard is a correction for "EN ISO 10993-1:2009"

  Related Standards

EN ISO 17665-1:2006

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

Sterilization of health care products - Moist heat - Part 1: Requirements for the development, validation and routine control of a...

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 10993-12:2012

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

Biological evaluation of medical devices - Part 12: Sample preparation and reference materials (ISO 10993-12:2012)

EN ISO 10993-13:2010

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

Biological evaluation of medical devices - Part 13: Identification and quantification of degradation products from polymeric medic...

EN ISO 13485:2016/AC:2018

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

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

EN ISO 10993-18:2009

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

Biological evaluation of medical devices - Part 18: Chemical characterization of materials (ISO 10993-18:2005)

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