NF EN ISO 11737-2

NF EN ISO 11737-2

January 2010
Standard Cancelled

Sterilization of medical devices - Microbiological methods - Part 2 : tests of sterility performed in the definition, validation and maintenance of a sterilization process

ISO 11737-2:2009 specifies the general criteria for tests of sterility on medical devices that have been exposed to a treatment with the sterilizing agent reduced relative to that anticipated to be used in routine sterilization processing. These tests are intended to be performed when defining, validating or maintaining a sterilization process.

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National standards and national normative documents

Publication date

January 2010

Number of pages

31 p.

Reference

NF EN ISO 11737-2

ICS Codes

07.100.10   Medical microbiology
11.080.01   Sterilization and disinfection in general

Classification index

S98-118-2

Print number

1 - 14/01/2010

International kinship

ISO 11737-2:2009

European kinship

EN ISO 11737-2:2009
Sumary
Sterilization of medical devices - Microbiological methods - Part 2 : tests of sterility performed in the definition, validation and maintenance of a sterilization process

ISO 11737-2:2009 specifies the general criteria for tests of sterility on medical devices that have been exposed to a treatment with the sterilizing agent reduced relative to that anticipated to be used in routine sterilization processing. These tests are intended to be performed when defining, validating or maintaining a sterilization process.

Replaced standards (1)
NF EN ISO 11737-2
June 2000
Standard Cancelled
Sterilisation of medical devices - Microbiological methods - Part 2 : tests of sterility performed in the validation of a sterilization process

La présente partie de l'ISO 11737 spécifie les critères généraux pour les essais de stérilité des dispositifs médicaux qui ont été soumis à un traitement avec l'agent de stérilisation correspondant à une fraction du procédé de stérilisation spécifié. Les essais décrits sont destinés à être pratiqués lors de la validation d'un procédé de stérilisation.La présente partie de l'ISO ne s'applique pas a) aux essais de stérilité pour une mise à disposition de routine d'un produit après un procédé de stérilisation;b) à l'essai de stérilité de la pharmacopée;NOTE 1 Les essais a) et b) ne font pas partie des prescriptions des normes ISO 11134, ISO 11135 ou ISO 11137.c) à la culture d'indicateurs biologiques, y compris les produits inoculés.NOTE2 Des méthodes de culture d'indicateurs biologiques sont décrites dans l'ISO 11138.

Standard replaced by (1)
NF EN ISO 11737-2
May 2020
Standard Current
Sterilization of health care products - Microbiological methods - Part 2 : tests of sterility performed in the definition, validation and maintenance of a sterilization process

1.1 This document specifies the general criteria for tests of sterility on medical devices that have been exposed to a treatment with the sterilizing agent which has been reduced relative to that anticipated to be used in routine sterilization processing. These tests are intended to be performed when defining, validating or maintaining a sterilization process. 1.2 This document is not applicable to: a) sterility testing for routine release of product that has been subjected to a sterilization process, b) performing a test for sterility (see 3.12), NOTE 1 The performance of a) or b) is not a requirement of ISO 11135, ISO 11137-1, ISO 11137-2, ISO 14160, ISO 14937, ISO 17665-1 or ISO 20857. c) test of sterility or test for sterility for demonstration of product shelf life, stability and/or package integrity, and d) culturing of biological indicators or inoculated products. NOTE 2 Guidance on culturing biological indicators is included in ISO 11138-7.

Table of contents
  • Avant-propos
    iv
  • Introduction
    v
  • 1 Domaine d'application
    1
  • 2 Références normatives
    1
  • 3 Termes et définitions
    2
  • 4 Éléments du système de management de la qualité
    3
  • 4.1 Documentation
    3
  • 4.2 Responsabilité de la direction
    4
  • 4.3 Réalisation du produit
    4
  • 4.4 Mesurages, analyse et amélioration
    4
  • 5 Sélection du produit
    4
  • 5.1 Généralités
    4
  • 5.2 Partie de l'objet échantillonné
    4
  • 5.3 Emballage du produit et portions d'articles d'échantillons
    5
  • 6 Méthodes utilisées pour les contrôles de stérilité
    5
  • 7 Évaluation de la méthode des contrôles de stérilité
    6
  • 8 Maintenance de la méthode des contrôles de stérilité
    6
  • Annexe A (informative) Directives concernant les contrôles de stérilité pratiqués au moment de la validation et de la maintenance d'un procédé de stérilisation
    7
  • Bibliographie
    16
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