NS EN ISO 10993-13 : 2010
Current
The latest, up-to-date edition.
BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 13: IDENTIFICATION AND QUANTIFICATION OF DEGRADATION PRODUCTS FROM POLYMERIC MEDICAL DEVICES
12-01-2013
1 Scope
2 Normative references
3 Definitions
4 Degradation test methods
4.1 General procedures
4.2 Accelerated degradation test
4.3 Real-time degradation test
5 Test procedures
5.1 Initial material characterization
5.2 Accelerated degradation test
5.3 Real-time degradation test
6 Test report
Annex A Analytical methods
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