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EN ISO 10993-5:2009 Standard

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  Keywords:

#amendment #cytotoxicity #vitro #tests #part

  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 5: Tests for in vitro cytotoxicity (ISO 10993-5:2009)

  Purpose

Amendment to EN ISO 10993-5:2009

  Publication

Friday 17th of November 2017

  Reference

This standard supersedes the "EN ISO 10993-5:1999"

Anyway is still possible use the "EN ISO 10993-5:1999" until December 31st, 2009

  Related Standards

EN ISO 10993-16:2010

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Biological evaluation of medical devices - Part 16: Toxicokinetic study design for degradation products and leachables (ISO 10993-...

EN ISO 13408-1:2015

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Aseptic processing of health care products - Part 1: General requirements (ISO 13408-1:2008, including Amd 1:2013)

EN ISO 10993-1:2009

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

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

EN ISO 10993-1:2009/AC:2010

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

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

EN ISO 10993-3:2014

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

Biological evaluation of medical devices - Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity (ISO 10993-3:...

EN ISO 10993-4:2009

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

Biological evaluation of medical devices - Part 4: Selection of tests for interactions with blood (ISO 10993-4:2002, including Amd...

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