Vlerësimi biologjik i pajisjeve mjekësore - Pjesa 9: Kuadri për identifikimin dhe përcaktimin e anës sasiore të produkteve potenciale të degraduara (ISO 10993-9:2009)

Biological evaluation of medical devices - Part 9: Framework for identification and quantification of potential degradation products (ISO 10993-9:2009)

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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.