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  • 10/30209603 DC : 0

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    Superseded A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
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    BS EN ISO 11608-2 - NEEDLE-BASED INJECTION SYSTEMS FOR MEDICAL USE - REQUIREMENTS AND TEST METHODS - PART 2: NEEDLES

    Available format(s):  Hardcopy, PDF

    Superseded date:  30-04-2012

    Language(s):  English

    Published date: 

    Publisher:  British Standards Institution

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

    1 Scope
    2 Normative references
    3 Terms and definitions
    4 Requirements
    5 Sampling
    6 Pre-conditioning of needles
    7 Standard atmosphere and apparatus
       for tests
    8 Determination of dislocation of measuring
       point at the patient-end
    9 Bond between hub and needle tube
    10 Packaging
    11 Test method for needle/injector systems
       compatibility validation
    12 Information supplied by the manufacturer
    Annex A (normative) - Determination of flow
            rate through needle
    Bibliography

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

    Comment Closes On
    Committee CH/84
    Document Type Draft
    Publisher British Standards Institution
    Status Superseded
    Superseded By

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

    ISO 683-13:1974 Heat-treated steels, alloy steels and free-cutting steels Part 13: Wrought stainless steels
    ISO 9626:2016 Stainless steel needle tubing for the manufacture of medical devices — Requirements and test methods
    ISO 11608-1:2014 Needle-based injection systems for medical use Requirements and test methods Part 1: Needle-based injection systems
    ISO 11608-3:2012 Needle-based injection systems for medical use Requirements and test methods Part 3: Finished containers
    ISO 7864:2016 Sterile hypodermic needles for single use — Requirements and test methods
    ISO 10993-1:2009 Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process
    ISO 6009:2016 Hypodermic needles for single use Colour coding for identification
    IEC 60068-2-30:2005 Environmental testing - Part 2-30: Tests - Test Db: Damp heat, cyclic (12 h + 12 h cycle)
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