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EN ISO 10993-6:2009 Standard

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  Keywords:

#part #solid #materials #biological #tests

  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 6: Tests for local effects after implantation (ISO 10993-6:2007)

  Purpose

This part of ISO 10993 specifies test methods for the assessment of the local effects after implantation of biomaterials intended for use in medical devices. This part of ISO 10993 applies to materials that are: - solid and non-biodegradable; - degradable and/or resorbable; - non-solid, such as porous materials, liquids, pastes and particulates.

  Publication

Friday 17th of November 2017

  Reference

This standard supersedes the "EN ISO 10993-6:2007"

Anyway is still possible use the "EN ISO 10993-6:2007" until March 21st, 2010

  Related Standards

EN 45502-2-2:2008/AC:2009

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EN ISO 11607-1:2020

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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 10993-13:2010

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

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 10993-9:2009

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

Biological evaluation of medical devices - Part 9: Framework for identification and quantification of potential degradation produc...

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