SN 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
Hardcopy
01-09-2010
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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
ISO 10993-13:2010 provides general requirements for the design of tests in a simulated environment for identifying and quantifying degradation products from finished polymeric medical devices ready for clinical use.
| Committee |
INB/NK 129
|
| DevelopmentNote |
Supersedes SN 119800. (06/2006)
|
| DocumentType |
Standard
|
| Pages |
0
|
| PublisherName |
Swiss Standards
|
| Status |
Current
|
| Supersedes |
| Standards | Relationship |
| DIN EN ISO 10993-13:2010-11 | Identical |
| NBN EN ISO 10993-13 : 2010 | Identical |
| NS EN ISO 10993-13 : 2010 | Identical |
| UNE-EN ISO 10993-13:2010 | Identical |
| ISO 10993-12:2012 | Identical |
| I.S. EN ISO 10993-13:2010 | Identical |
| BS EN ISO 10993-13:2010 | Identical |
| NF EN ISO 10993-13 : 2010 | Identical |
| UNI EN ISO 10993-13 : 2010 | Identical |
| ISO 10993-13:2010 | Identical |
| NEN EN ISO 10993-13 : 2010 | Identical |
| EN ISO 10993-13:2010 | Identical |
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