NF EN ISO 10993-5 : 2010
Current
The latest, up-to-date edition.
BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 5: TESTS FOR IN VITRO CYTOTOXICITY
12-01-2013
1 Domaine d'application
2 Références normatives
3 Termes et définitions
4 Préparation des échantillons
5 Lignées cellulaires
6 Milieu de culture
7 Préparation de la culture-stock cellulaire
8 Modes opératoires d'essai
9 Rapport d'essai
10 Interprétation des résultats
Specifies test procedures to assess the in vitro cytotoxicity of medical devices. Describes the incubation of cultured cells either directly or through diffusion in contact with a device and / or with extracts of a device.
| DevelopmentNote |
Indice de Classement: S99-501-5. Supersedes NF EN 30993-5. (04/2003) Supersedes NFS 99 505 (03/2004) PR NF EN ISO 10993-5 June 2007. (06/2007) New child AMD 11 2025 is now added
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| DocumentType |
Standard
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| ProductNote |
New child AMD 11 2025 is now added
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| PublisherName |
Association Francaise de Normalisation
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| Status |
Current
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| Supersedes |
| Standards | Relationship |
| BS EN ISO 10993-5:2009 | Identical |
| EN ISO 10993-5:2009 | Identical |
| I.S. EN ISO 10993-5:2009 | Identical |
| ONORM EN ISO 10993-5 : 2009 | Identical |
| NS EN ISO 10993-5 : 2009 | Identical |
| NEN EN ISO 10993-5 : 2009 | Identical |
| DIN EN ISO 10993-5:2009-10 | Identical |
| NBN EN ISO 10993-5 : 2009 | Identical |
| ISO 10993-5:2009 | Identical |
| UNE-EN ISO 10993-5:2009 | Identical |
| XP S94 091 : 2008 XP | IMPLANTS FOR SURGERY - VALIDATION OF THE CLEANING OF ORTHOPAEDIC IMPLANTS BEFORE FINAL CONDITIONING |
| NFS 94 091 : 2013 | IMPLANTS CHIRURGICAUX - EXIGENCES DE VALIDATION POUR LE PROCEDE DE NETTOYAGE DES IMPLANTS ORTHOPEDIQUES AVANT CONDITIONNEMENT FINAL |
| NF EN ISO 7405 : 2009 AMD 1 2013 | DENTISTRY - EVALUATION OF BIOCOMPATIBILITY OF MEDICAL DEVICES USED IN DENTISTRY |
| NFS 11 820 : 2012 | CONTACT LENS SOLUTIONS - EVALUATION OF OCULAR CYTOTOXIC POTENTIAL OF LENS SOLUTION PRODUCTS |
| ISO 10993-12:2012 | Biological evaluation of medical devices — Part 12: Sample preparation and reference materials |
| ISO 10993-1:2009 | Biological evaluation of medical devices — Part 1: Evaluation and testing within a risk management process |
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