NEN-EN-ISO 10993-9
Biological evaluation of medical devices - Part 9: Framework for identification and quantification of potential degradation products
inactive
| Organization: | NEN |
| Publication Date: | 1 March 2007 |
| Status: | inactive |
| Page Count: | 20 |
| ICS Code (Biological evaluation of medical devices): | 11.100.20 |
scope:
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
Document History
January 1, 2010
Biological evaluation of medical devices - Part 9: Framework for identification and quantification of potential degradation products
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...
June 1, 2009
Biological evaluation of medical devices - Part 9: Framework for identification and quantification of potential degradation products
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...
NEN-EN-ISO 10993-9
March 1, 2007
Biological evaluation of medical devices - Part 9: Framework for identification and quantification of potential degradation products
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...
April 1, 1999
Biological evaluation of medical devices - Part 9: Framework for identification and quantification of potential degradation products
Provides general principles for the systematic evaluation of the potential and observed biodegradation of medical devices and on the design and performance of biodegradation studies.
January 1, 1998
Biological evaluation of medical devices - Part 9: Framework for identification and quantification of potential degradation products
Provides general principles for the systematic evaluation of the potential and observed biodegradation of medical devices and on the design and performance of biodegradation studies.