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  • NEN EN ISO 11608-1 : 2015

    Current The latest, up-to-date edition.
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    NEEDLE-BASED INJECTION SYSTEMS FOR MEDICAL USE - REQUIREMENTS AND TEST METHODS - PART 1: NEEDLE-BASED INJECTION SYSTEMS

    Available format(s): 

    Language(s): 

    Published date:  13-01-2013

    Publisher:  Netherlands Standards

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

    Contents
    Foreword
    Introduction
    1 Scope
    2 Normative references
    3 Terms and definitions
    4 Symbols and abbreviations
    5 General requirements
    6 Test conditions
    6.1 Standard atmosphere
    6.2 Cool atmosphere
    6.3 Hot atmosphere
    7 Preconditioning of pen-injectors
    7.1 Preconditioning in dry heat atmosphere
    7.2 Preconditioning in cold storage atmosphere
    7.3 Preconditioning in cyclical atmosphere
    7.4 Preconditioning by free fall
    7.5 Preconditioning by vibration for
          pen-injectors with electronic components
    8 Reagent and apparatus
    9 Determination f dose accuracy
    9.1 Dose accuracy
    9.2 Dose accuracy requirements
    10 Freedom from defects
    10.1 Defects after being subjected to cyclical
          preconditioning
    10.2 Freedom from defects after being subjected
          to vibration
    10.3 Freedom from defects after being subjected
          to free fall
    11 Determination of electromagnetic
          compatibility
    11.1 Electromagnetic compatibility (EMC)
    11.2 Electrostatic discharge
    11,3 Radiated radio frequency (RF) fields
    12 Visual inspection
    13 Functional inspection
    13.1 Replaceable cartridge
    13.2 Nonreplaceable cartridge
    13.3 Accuracy
    14 Test report
    15 Information supplied by the manufacturer
    15.1 General
    15.2 Marking
    15.3 Instructions for use
    Annex A (informative) Two-sided tolerance limit
          factors (k)
    Bibliography

    Abstract - (Show below) - (Hide below)

    Defines requirements and test methods for needle-based injection systems (NISs) intended to be used with needles and with replaceable or non-replaceable containers.

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    Document Type Standard
    Publisher Netherlands Standards
    Status Current
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