[Download free pdf] ISO 10993-9:1999, Biological evaluation of medical devices -- Part 9: Framework for identification and quantification of potential degradation products
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.This part of ISO 10993 is not applicable to:viable-tissue engineered products; methodologies for the generation of degradation products by mechanical processes. Methodologies for the production of this type of degradation product are described in specific product stan...
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