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NF EN 1174-3 : 1997

Superseded

Superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.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

Superseded date

01-07-2006

Published date

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Superseded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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