NF EN 1174-3 : 1997
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
STERILIZATION OF MEDICAL DEVICES - ESTIMATION OF THE POPULATION OF MICRO-ORGANISMS ON PRODUCT - PART 3: GUIDE TO THE METHODS FOR VALIDATION OF MICROBIOLOGICAL TECHNIQUES
01-07-2006
12-01-2013
Avant-propos
Introduction
1 Domaine d'application
2 Référence normative
3 Définitions
4 Validation de la technique d'élimination des
micro-organismes d'un produit
5 Évaluation des conditions de culture
6 Techniques de recherche pour la libération de substances
qui affecteraient défavorablement les estimations de la
charge microbienne
Annexe A (informative) Exemples pratiques illustrant le
calcul des coefficients de correction
Annexe B (informative) Bibliographie
Annexe ZA (informative) Articles de la présente norme
européenne concernant les exigences essentielles ou
d'autres dispositions des Directives UE
Describes approaches for validation techniques for bioburden estimation. Not intended as an exhaustive guide but for highlighting of important aspects of methodology requiring attention. Designed to be informative but does not specify requirements.
| DocumentType |
Standard
|
| PublisherName |
Association Francaise de Normalisation
|
| Status |
Superseded
|
| Standards | Relationship |
| EN 1174-3 : 1996 | Identical |
| DIN EN 1174-3:1997-02 | Identical |
| UNE-EN 1174-3:1997 | Identical |
| BS EN 1174-3:1997 | Identical |
| I.S. EN 1174-3:1997 | Identical |
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