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  • 14/30294895 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    Superseded A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.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 8537 - STERILE SINGLE-USE SYRINGES, WITH OR WITHOUT NEEDLE, FOR INSULIN

    Available format(s):  Hardcopy, PDF

    Superseded date:  30-04-2016

    Language(s):  English

    Published date: 

    Publisher:  British Standards Institution

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

    Foreword
    Introduction
    1 Scope
    2 Normative references
    3 Terms and definitions
    4 Types of syringes
    5 Requirements
    6 Packaging
    7 Information supplied by the manufacturer
    Annex A (normative) - Fluid for determination of acidity/alkalinity and
            extractable metals
    Annex B (normative) - Test method for air leakage past syringe piston
            during aspiration and for separation of rubber stopper
            and plunger
    Annex C (normative) - Test method for determination of forces
            required to operate piston
    Annex D (normative) - Test method for determination of dead space
    Annex E (normative) - Test method for liquid leakage at syringe
            piston and syringe nozzle/hub or
            needle/barrel unions during compression
    Annex F (normative) - Test method for air leakage past nozzle/hub
            or needle/barrel unions during aspiration
    Annex G (normative) - Preparation of extract for test for pyrogenicity
            and toxicity
    Annex H (normative) - Syringe sizes and graduated scales
    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    Status Superseded
    Superseded By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 9626:2016 Stainless steel needle tubing for the manufacture of medical devices — Requirements and test methods
    IEC 62366:2007+AMD1:2014 CSV Medical devices - Application of usability engineering to medical devices
    ISO 81714-1:2010 Design of graphical symbols for use in the technical documentation of products Part 1: Basic rules
    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 14971:2007 Medical devices Application of risk management to medical devices
    ISO 15223-1:2016 Medical devices Symbols to be used with medical device labels, labelling and information to be supplied Part 1: General requirements
    ISO 594-1:1986 Conical fittings with a 6 % (Luer) taper for syringes, needles and certain other medical equipment Part 1: General requirements
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