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EN ISO 10993-9:2009 Standard

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  Keywords:

#part #studies #resorbable #biodegradation #framework

This standard is superseded by:
  •   EN ISO 10993-9:2009 from: 2010-03-21
  •   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

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