ISO 10993-9:2009

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

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

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Referenced standards

ISO 10993-13:1998ISO 10993-14:2001ISO 10993-15:2000ISO 10993-1:2009ISO 10993-2:2006
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Biological evaluation of medical devices — Part 9: Framework for identification and quantification of potential degradation products

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.

Edition2009
Standard Part No9
Published Date2009
Published ByInternational Standardization Organisation
Page Count9