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EN ISO 10993-9:2009 Standard

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  Keywords:

#part #studies #resorbable #biodegradation #framework

  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 9: Framework for identification and quantification of potential degradation products (ISO 10993-9:2009)

  Purpose

This part of ISO 10993 provides general principles for the systematic evaluation of the potential and observed biodegradation of medical devices and for the design and performance of biodegradation studies. Information obtained from these studies can be used in the biological evaluation described in the ISO 10993 series. This part of ISO 10993 considers both non-resorbable and resorbable materials.

  Publication

Friday 17th of November 2017

  Related Standards

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EN ISO 10993-12:2012

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EN ISO 10993-7:2008/AC:2009

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Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals (ISO 10993-7:2008)

EN ISO 10993-7:2008

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

Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals (ISO 10993-7:2008)

EN ISO 10993-6:2009

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

Biological evaluation of medical devices - Part 6: Tests for local effects after implantation (ISO 10993-6:2007)

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