TSE - TS EN ISO 10993-9
Biological evaluation of medical devices - Part 9: Framework for identification and quantification of potential degradation products
| Organization: | TSE |
| Publication Date: | 11 July 2016 |
| Status: | active |
| ICS Code (Biological evaluation of medical devices): | 11.100.20 |
scope:
This part of ISO 10993 provides general principles for thesystematic evaluation of the potential and observed biodegradationof medical devices and for the design and performance ofbiodegradation studies. Information obtained from these studies canbe used in the biological evaluation described in the ISO 10993series. This part of ISO 10993 considers both non-resorbable andresorbable materials.
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