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  • NF EN ISO 11737-2 : 2010

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    Withdrawn A Withdrawn Standard is one, which is removed from sale, and its unique number can no longer be used. The Standard can be withdrawn and not replaced, or it can be withdrawn and replaced by a Standard with a different number.
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    STERILIZATION OF MEDICAL DEVICES - MICROBIOLOGICAL METHODS - PART 2: TESTS OF STERILITY PERFORMED IN THE DEFINITION, VALIDATION AND MAINTENANCE OF A STERILIZATION PROCESS

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    Withdrawn date:  28-10-2021

    Language(s): 

    Published date:  12-01-2013

    Publisher:  Association Francaise de Normalisation

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    Table of Contents - (Show below) - (Hide below)

    Avant-propos
    Introduction
    1 Domaine d'application
    2 Références normatives
    3 Termes et définitions
    4 Éléments du système de management de la qualité
    5 Sélection du produit
    6 Méthodes utilisées pour les controles de stérilité
    7 Évaluation de la méthode des controles de stérilité
    8 Maintenance de la méthode des controles de stérilité
    Annexe A (informative) - Directives concernant les controles
             de stérilité pratiqués au moment de la validation et
             de la maintenance d'un procédé de stérilisation
    Bibliographie

    Abstract - (Show below) - (Hide below)

    Establishes the general requirements for tests on medical devices that have been exposed to a treatment with the sterilizing agent that is a fraction of the specified sterilization process. These tests are intended to be carried out when validating a sterilization process. Does not apply to sterility testing for routine release of product that has been subjected to a sterilization process, nor to performance of a pharmacopoeial sterility test.

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    Development Note Indice de classement: S98-118-2. Supersedes NFS 98 118. (03/2004) PR NF EN ISO 11737-2 February 2008. (02/2008)
    Document Type Standard
    Publisher Association Francaise de Normalisation
    Status Withdrawn
    Superseded By
    Supersedes

    Standards Referenced By This Book - (Show below) - (Hide below)

    NF EN ISO 11135-1 : 2007 STERILIZATION OF HEALTH CARE PRODUCTS - ETHYLENE OXIDE - PART 1: REQUIREMENTS FOR DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES

    Standards Referencing This Book - (Show below) - (Hide below)

    ISO/IEC 17025:2005 General requirements for the competence of testing and calibration laboratories
    ISO 11737-1:2006 Sterilization of medical devices Microbiological methods Part 1: Determination of a population of microorganisms on products
    ISO 13485:2016 Medical devices Quality management systems Requirements for regulatory purposes
    ISO 10012:2003 Measurement management systems — Requirements for measurement processes and measuring equipment
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