2nd Edition, December 15, 2009
Biological evaluation of medical devices — Part 9: Framework for identification and quantification of potential degradation products
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Description / Abstract:
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