NF 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 Domaine d'application
2 Références normatives
3 Définitions
4 Méthodes d'essai de dégradation
5 Mode opératoire d'essai
6 Rapport d'essai
Annexe A - Méthodes analytiques
Gives guidance on general requirements for designing of tests for identification and quantifying degradation products from finished polymeric medical devices ready for clinical use.
| DevelopmentNote |
Indice de classement: S99-501-13. Supersedes NFS 99 513. (03/2004) PR NF EN ISO 10993-13 November 2008. (11/2008) PR NF EN ISO 10993-13 February 2009. (02/2009)
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| DocumentType |
Standard
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| PublisherName |
Association Francaise de Normalisation
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| Status |
Current
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| Supersedes |
| 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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