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  • 15/30289037 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    Superseded A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.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 7886-1 - STERILE HYPODERMIC SYRINGES FOR SINGLE USE - PART 1: SYRINGES FOR MANUAL USE

    Available format(s):  Hardcopy, PDF

    Superseded date:  13-04-2018

    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 Nomenclature
    5 General requirements
    6 Extraneous matter
    7 Lubricant
    8 Tolerance on graduated capacity
    9 Graduated scale
    10 Barrel
    11 Plunger stopper/plunger assembly
    12 Nozzle
    13 Performance
    14 Packaging
    15 Information supplied by the manufacturer
    Annex A (normative) - Method for preparation of
            extracts
    Annex B (normative) - Test method for air leakage
            past syringe plunger stopper during aspiration,
            and for separation of plunger stopper and plunger
    Annex C (normative) - Method for determination of dead
            space
    Annex D (normative) - Test method for liquid leakage at
            syringe plunger stopper under compression
    Annex E (informative) - Examples of test methods for
            incompatibility between syringes and injection fluids
    Annex F (normative) Test method for forces required to
            operate plunger
    Annex G (informative) - Test method for the quantity of silicone
    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    Status Superseded
    Superseded By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 15223-2:2010 Medical devices — Symbols to be used with medical device labels, labelling, and information to be supplied — Part 2: Symbol development, selection and validation
    ISO 8537:2016 Sterile single-use syringes, with or without needle, for insulin
    ISO 80369-20:2015 Small-bore connectors for liquids and gases in healthcare applications Part 20: Common test methods
    ISO 384:2015 Laboratory glass and plastics ware Principles of design and construction of volumetric instruments
    ISO 8601:2004 Data elements and interchange formats Information interchange Representation of dates and times
    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 3696:1987 Water for analytical laboratory use — Specification and test methods
    ISO 23908:2011 Sharps injury protection Requirements and test methods Sharps protection features for single-use hypodermic needles, introducers for catheters and needles used for blood sampling
    ISO 14971:2007 Medical devices Application of risk management to medical devices
    ISO 594-2:1998 Conical fittings with 6 % (Luer) taper for syringes, needles and certain other medical equipment Part 2: Lock fittings
    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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