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Full Description

ISO 10993-9:2008 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. ISO 10993-9:2008 considers both non-resorbable and resorbable materials.

 

Document History

  1. ISO 10993-9:2019


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

    • Most Recent
  2. ISO 10993-9:2009

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

    • Historical Version
  3. ISO 10993-9:1999


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

    • Historical Version