1 Scope
This document provides general principles for the systematic evaluation of the potential
and observed degradation of medical devices through the design and performance of in vitro degradation studies. Information obtained from these studies can be used in the biological evaluation
described in the ISO 10993 series.
This document is applicable to both materials designed to degrade in the body as well
as materials that are not intended to degrade.
This document is not applicable to:
a) the evaluation of degradation which occurs by purely mechanical processes; methodologies for the production of
this type of degradation product are described in specific product standards, where available;
NOTE Purely mechanical degradation causes mostly particulate matter. Although this is excluded from the scope of this
document, such degradation products can evoke a biological response and can undergo biological evaluation as
described in other parts of ISO 10993.
b)
leachable
components which are not degradation products;
BS EN ISO 10993-9:2021 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