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  • UNI EN ISO 11608-1 : 2012

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    Superseded A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
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    NEEDLE-BASED INJECTION SYSTEMS FOR MEDICAL USE - REQUIREMENTS AND TEST METHODS - PART 1: NEEDLE-BASED INJECTION SYSTEMS

    Available format(s): 

    Superseded date:  14-07-2022

    Language(s): 

    Published date:  01-01-2012

    Publisher:  Ente Nazionale Italiano di Unificazione (UNI)

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

    Foreword
    Introduction
    1 Scope
    2 Normative references
    3 Terms and definitions
    4 Symbols and abbreviated terms
    5 Requirements
    6 Reagent and apparatus
    7 Determination of dose accuracy
    8 Preparation and operation of NISs
    9 Test matrix
    10 Test descriptions
    11 Inspection
    12 Test report
    13 Information supplied by the manufacturer
    Annex A (informative) - Dose replicates,
            accuracy and testing rationale
    Annex B (normative) - One- and 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 Ente Nazionale Italiano di Unificazione (UNI)
    Status Superseded
    Superseded By
    Supersedes
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