NF EN 1174-3

NF EN 1174-3

January 1997
Standard Cancelled

Sterilization of medical devices. Estimation of the population of micro-organisms on product. Part 3 : guide to the methods for validation of microbiological techniques.

Le présent document décrit les approches pouvant être suivies lors de la validation des techniques d'estimation de la charge microbienne.

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Main informations

Collections

National standards and national normative documents

Publication date

January 1997

Number of pages

14 p.

Reference

NF EN 1174-3

ICS Codes

07.100.10   Medical microbiology
11.080.01   Sterilization and disinfection in general

Classification index

S98-110-3

Print number

1 - 01/01/1997
Sumary
Sterilization of medical devices. Estimation of the population of micro-organisms on product. Part 3 : guide to the methods for validation of microbiological techniques.

Le présent document décrit les approches pouvant être suivies lors de la validation des techniques d'estimation de la charge microbienne.
Standard replaced by (1)
NF EN ISO 11737-1
July 2006
Standard Cancelled
Sterilization of medical devices - Microbiological methods - Part 1 : determination of a population of microorganisms on products

ISO 11737-1:2006 specifies requirements and provides guidance for the enumeration and microbial characterization of the population of viable micro-organisms on or in a medical device, component, raw material or package.

Table of contents
  • Avant-propos
    3
  • Introduction
    4
  • 1 Domaine d'application
    4
  • 2 Référence normative
    4
  • 3 Définitions
    4
  • 4 Validation de la technique d'élimination des micro-organismes d'un produit
    4
  • 5 Évaluation des conditions de culture
    6
  • 6 Techniques de recherche pour la libération de substances qui affecteraient défavorablement les estimations de la charge microbienne
    7
  • Annexe A (informative) Exemples pratiques illustrant le calcul des coefficients de correction
    8
  • Annexe B (informative) Bibliographie
    11
  • Annexe ZA (informative) Articles de la présente norme européenne concernant les exigences essentielles ou d'autres dispositions des Directives UE
    12
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