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  • NF EN ISO 11608-4 : 2007

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    Superseded A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
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    PEN-INJECTORS FOR MEDICAL USE - PART 4: REQUIREMENTS AND TEST METHODS FOR ELECTRONIC AND ELECTROMECHANICAL PEN-INJECTORS

    Available format(s): 

    Superseded date:  30-01-2023

    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 Symboles et abréviations
    5 Exigences générales
    6 Conditions d'essai
    7 Préconditionnement des stylos-injecteurs
    8 Réactifs et appareillage
    9 Détermination de la précision de dosage
    10 Absence de défauts
    11 Détermination de la compatibilité électromagnétique
    12 Sécurité électrique
    13 Controle visuel
    14 Controle de fonctionnement
    15 Rapport d'essai
    16 Informations fournies par le fabricant
    Bibliographie

    Abstract - (Show below) - (Hide below)

    Defines requirements and test methods for electromechanically driven injectors intended to be used with needles and with replaceable or non-replaceable cartridges.

    General Product Information - (Show below) - (Hide below)

    Development Note Indice de classement: S93-020-4PR. PR NF EN ISO 11608-4 May 2007. (05/2007) PR NF EN ISO 11608-4 March 2016. (04/2016)
    Document Type Standard
    Publisher Association Francaise de Normalisation
    Status Superseded
    Superseded By

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

    NF EN 60068 2-64 : 2008 ENVIRONMENTAL TESTING - PART 2-64: TESTS - TEST FH: VIBRATION, BROADBAND RANDOM AND GUIDANCE
    NF EN 60601-1-2 : 2016 MEDICAL ELECTRICAL EQUIPMENT - PART 1-2: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - COLLATERAL STANDARD: ELECTROMAGNETIC DISTURBANCES - REQUIREMENTS AND TESTS
    NF EN 60068 2-27 : 2009 ENVIRONMENTAL TESTING - PART 2-27: TESTS - TEST EA AND GUIDANCE: SHOCK
    NF EN ISO 11608-1 : 2015 NEEDLE-BASED INJECTION SYSTEMS FOR MEDICAL USE - REQUIREMENTS AND TEST METHODS - PART 1: NEEDLE-BASED INJECTION SYSTEMS
    NF EN 60068 2-30 : 2006 ENVIRONMENTAL TESTING - PART 2-30: TESTS - TEST DB AND GUIDANCE: DAMP HEAT, CYCLIC (12 H + 12 H CYCLE)
    NF EN 60601-1-1 : 2001 MEDICAL ELECTRICAL EQUIPMENT - PART 1-1: GENERAL REQUIREMENTS FOR SAFETY - COLLATERAL STANDARD: SAFETY REQUIREMENTS FOR MEDICAL ELECTRICAL SYSTEMS
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