CEN - EN ISO 10993-9
Biological evaluation of medical devices - Part 9: Framework for identification and quantification of potential degradation products
|Publication Date:||1 December 2009|
|ICS Code (Biological evaluation of medical devices):||11.100.20|
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;
NOTE 1 Purely mechanical degradation causes mostly particulate matter. Although this is excluded from the scope of this part of ISO 10993, such degradation products can evoke a biological response and thus need to undergo biological evaluation as described in other parts of ISO 10993.
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.