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 vitrodegradation 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:
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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.
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b)
leachable
components which are not degradation products;
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c) medical devices or components that do not contact the patient's body directly or indirectly.