ISO 10993-9:2009
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.
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Scope
Normative references
Terms and definitions
Principles for design of degradation studies
General
Preliminary considerations
Study design
Characterization of degradation products from medical device
Study report
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Scope
Normative references
Terms and definitions
Principles for design of degradation studies
General
Preliminary considerations
Study design
Characterization of degradation products from medical device
Study report