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
Gives guidance on general requirements for designing of tests for identification and quantifying degradation products from finished polymeric medical devices ready for clinical use.
| DocumentType |
Standard
|
| PublisherName |
Norwegian Standards (Norges Standardiseringsforbund)
|
| Status |
Current
|
| Standards | Relationship |
| ISO 10993-13:2010 | Identical |
| EN ISO 10993-13:2010 | Identical |
| SN EN ISO 10993-13:2010 | Identical |
| UNE-EN ISO 10993-13:2010 | Identical |
| I.S. EN ISO 10993-13:2010 | Identical |
| UNI EN ISO 10993-13 : 2010 | Identical |
| BS EN ISO 10993-13:2010 | Identical |
| DIN EN ISO 10993-13:2010-11 | Identical |
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