<p>This document provides general principles for the systematic evaluation of the potential and observed degradation of medical devices through the design and performance of <i>in vitro</i> degradation studies. Information obtained from these studies can be used in the biological evaluation described in the ISO 10993 series.</p>
<p>This document is applicable to both materials designed to degrade in the body as well as materials that are not intended to degrade.</p>
<p>This document is not applicable to:</p>
<p>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;</p>
<p>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.</p>
<p>b) leachable components which are not degradation products;</p>
<p>c) medical devices or components that do not contact the patient's body directly or indirectly.</p>
Registration number (WIID)
64580
Scope
<p>This document provides general principles for the systematic evaluation of the potential and observed degradation of medical devices through the design and performance of <i>in vitro</i> degradation studies. Information obtained from these studies can be used in the biological evaluation described in the ISO 10993 series.</p>
<p>This document is applicable to both materials designed to degrade in the body as well as materials that are not intended to degrade.</p>
<p>This document is not applicable to:</p>
<p>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;</p>
<p>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.</p>
<p>b) leachable components which are not degradation products;</p>
<p>c) medical devices or components that do not contact the patient's body directly or indirectly.</p>
