NF EN ISO 10993-9 : 2010
Current
The latest, up-to-date edition.
BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 9: FRAMEWORK FOR IDENTIFICATION AND QUANTIFICATION OF POTENTIAL DEGRADATION PRODUCTS
12-01-2013
1 Domaine d'application
2 Références normatives
3 Termes et définitions
4 Principes relatifs à la conception des études de
dégradation
5 Rapport d'étude
Annexe A (normative) - Analyse du besoin d'études de
dégradation
Annexe B (informative) - Considérations relatives à
l'étude de la biodégradation
Bibliographie
Gives general principles of systematic evaluating of the potential and observed biodegradation of medical devices and for designing and performing biodegradation studies.
| DevelopmentNote |
Indice de classement: S99-501-9. Supersedes NFS 99 509. (03/2004) PR NF EN ISO 10993-9 May 2007. (05/2007) PR NF EN ISO 10993-9 March 2009. (03/2009)
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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 |
| UNE-EN ISO 10993-9:2010 | Identical |
| UNI EN ISO 10993-9 : 2010 | Identical |
| NS EN ISO 10993-9 : 2009 | Identical |
| EN ISO 10993-9:2009 | Identical |
| SN EN ISO 10993-9 : 2010 | Identical |
| ONORM EN ISO 10993-9 : 2010 | Identical |
| ISO 10993-9:2009 | Identical |
| BS EN ISO 10993-9 : 2009-12 | Identical |
| I.S. EN ISO 10993-9:2009-12 | Identical |
| DIN EN ISO 10993-9:2010-04 | Identical |
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