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) teachable 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.
BS EN ISO 10993-9:1999 history
2022BS EN ISO 10993-9:2021 Biological evaluation of medical devices. Framework for identification and quantification of potential degradation products
2010BS EN ISO 10993-9:2009 Biological evaluation of medical devices - Framework for identification and quantification of potential degradation products
1999BS EN ISO 10993-9:1999 Biological evaluation of medical devices - Framework for identification and quantification of potential degradation products