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EVS-EN ISO 10993-9:2010

Biological evaluation of medical devices - Part 9: Framework for identification and quantification of potential degradation products

General information
Valid from 04.03.2010
Base Documents
ISO 10993-9:2009; EN ISO 10993-9:2009
Standard history
Status
Date
Type
Name
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prEN ISO 10993-9
04.03.2010
Main
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.
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