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:
a) viable-tissue engineered products;
b) 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 standards, where available;
c) leachable components which are not degradation products.
Where product standards provide applicable product-specific methodologies for the identification and quantification of degradation products, those standards shall be considered as alternatives.
ISO 10993-9:1999 Referenced Document
ISO 10993-1:1997 Biological evaluation of medical devices - Part 1: Evaluation and testing
ISO 10993-2:1992 Biological evaluation of medical devices; part 2: animal welfare requirements
ISO 10993-9:1999 history
2019ISO 10993-9:2019 Biological evaluation of medical devices — Part 9: Framework for identification and quantification of potential degradation products
2009ISO 10993-9:2009 Biological evaluation of medical devices - Part 9: Framework for identification and quantification of potential degradation products
1999ISO 10993-9:1999 Biological evaluation of medical devices - Part 9: Framework for identification and quantification of potential degradation products