NF EN ISO 11138-7

NF EN ISO 11138-7

April 2019
Standard Current

Sterilization of health care products - Biological indicators - Part 7 : guidance for the selection, use and interpretation of results

This document provides guidance for the selection, use and interpretation of results from application of biological indicators when used in the development, validation and routine monitoring of sterilization processes. It does not consider those processes that rely solely on physical removal of microorganisms, e.g. filtration. It is not applicable to combination processes using, for example, washer-disinfectors or flushing and steaming of pipelines. It does not specify requirements for the selection and use of biological indicators intended to monitor vaporised hydrogen peroxide processes for isolator and room biodecontamination processes at atmospheric pressure. It is not applicable to liquid immersion sterilization processes.

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Main informations

Collections

National standards and national normative documents

Publication date

April 2019

Number of pages

74 p.

Reference

NF EN ISO 11138-7

ICS Codes

11.080.01   Sterilization and disinfection in general

Classification index

S98-004-7

Print number

1

International kinship

ISO 11138-7:2019

European kinship

EN ISO 11138-7:2019
Sumary
Sterilization of health care products - Biological indicators - Part 7 : guidance for the selection, use and interpretation of results

This document provides guidance for the selection, use and interpretation of results from application of biological indicators when used in the development, validation and routine monitoring of sterilization processes.

It does not consider those processes that rely solely on physical removal of microorganisms, e.g. filtration.

It is not applicable to combination processes using, for example, washer-disinfectors or flushing and steaming of pipelines.

It does not specify requirements for the selection and use of biological indicators intended to monitor vaporised hydrogen peroxide processes for isolator and room biodecontamination processes at atmospheric pressure.

It is not applicable to liquid immersion sterilization processes.

Replaced standards (1)
NF EN ISO 14161
November 2009
Standard Cancelled
Sterilization of health care products - Biological indicators - Guidance for the selection, use and interpretation of results

<p>ISO 14161:2009 provides guidance for the selection, use and interpretation of results from application of biological indicators when used in the development, validation and routine monitoring of sterilization processes.</p> <p>ISO 14161:2009 applies to biological indicators for which International Standards exist.</p>

Table of contents
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  • 1 Domaine d'application
  • 2 Références normatives
  • 3 Termes et définitions
  • 4 Généralités
  • 5 Caractéristiques des indicateurs biologiques
  • 6 Choix du fournisseur
  • 7 Indicateurs biologiques dans la mise au point de procédés
  • 8 Indicateurs biologiques dans la validation de la stérilisation
  • 9 Indicateurs biologiques et surveillance de routine
  • 10 Interprétation et critères d'acceptation
  • 11 Application des normes relatives aux indicateurs biologiques
  • 12 Conditions de culture
  • 13 Considérations relatives aux tierces parties
  • 14 Formation du personnel
  • 15 Stockage et manipulation
  • 16 Mise au rebut des indicateurs biologiques
  • Annexe A Cinétique d'inactivation microbiologique et techniques de dénombrement
  • Annexe B Dispositifs d'épreuve de procédé
  • Annexe C Formules des méthodes par fraction négative pour les calculs de la valeur D
  • Annexe D Exemples de documentation relative aux indicateurs biologiques préparés par l'utilisateur
  • Annexe E Calcul de la valeur de z
  • Annexe F Détermination de la valeur D par la méthode de la courbe de survie
  • Annexe G Caractéristiques de réponse survie/destruction
  • Bibliographie
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