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. Information
obtained from these studies can be used in the biological evaluation described in the ISO 10993 series. This
part of ISO 10993 considers both non-resorbable and resorbable materials.
This part of ISO 10993 is not applicable to:
a) 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;
b) leachable components which are not degradation products;
c) medical devices or components that do not contact the patient's body directly or indirectly.
NOTE 2 This part of ISO 10993 can be applied to the degradation of materials used in any kind of product that falls
within the definition of “medical device” in ISO 10993-1, even if such products are subject to different regulations from
those applying to medical devices, e.g. the scaffold in a tissue engineered medical product, or a carrier matrix to deliver
drugs or biologics.