UNE-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 (ISO 10993-13:2010)
Hardcopy , PDF
Spanish, Castilian, English
17-11-2010
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
This part of ISO 10993 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 |
CTN 111
|
| DocumentType |
Standard
|
| Pages |
26
|
| PublisherName |
Asociación Española de Normalización
|
| Status |
Current
|
| Standards | Relationship |
| DIN EN ISO 10993-13:2010-11 | Identical |
| NBN EN ISO 10993-13 : 2010 | Identical |
| NS EN ISO 10993-13 : 2010 | Identical |
| I.S. EN ISO 10993-13:2010 | Identical |
| BS EN ISO 10993-13:2010 | Identical |
| NF EN ISO 10993-13 : 2010 | Identical |
| ISO 10993-13:2010 | Identical |
| NEN EN ISO 10993-13 : 2010 | Identical |
| EN ISO 10993-13:2010 | Identical |
| ISO 13781:2017 | Implants for surgery — Homopolymers, copolymers and blends on poly(lactide) — In vitro degradation testing |
| ISO 10993-12:2012 | Biological evaluation of medical devices — Part 12: Sample preparation and reference materials |
| ISO 10993-17:2002 | Biological evaluation of medical devices — Part 17: Establishment of allowable limits for leachable substances |
| ISO 10993-1:2009 | Biological evaluation of medical devices — Part 1: Evaluation and testing within a risk management process |
| ISO 10993-9:2009 | Biological evaluation of medical devices — Part 9: Framework for identification and quantification of potential degradation products |
| ISO 3696:1987 | Water for analytical laboratory use — Specification and test methods |
| ISO 14971:2007 | Medical devices — Application of risk management to medical devices |
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