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  • UNE-EN ISO 8537:2016

    Current The latest, up-to-date edition.

    Sterile single-use syringes, with or without needle, for insulin (ISO 8537:2016)

    Available format(s):  Hardcopy, PDF

    Language(s):  Spanish, Castilian, English

    Published date:  16-11-2016

    Publisher:  Asociacion Espanola de Normalizacion

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

    Committees responsible
    National foreword
    Introduction
    Specification
    1. Scope
    2. Normative references
    3. Definitions and nomenclature
    4. Types of syringe
    5. Freedom from extraneous matter
    6. Limits for extractable matter
    7. Lubrication of syringes and needles
    8. Range of sizes
    9. Graduated scale
    10. Barrel
    11. Piston/plunger assembly
    12. Nozzle
    13. Needles
    14. Performance of assembled syringe
    15. Packaging
    16. Marking
    Annexes
    A. Fluid for determination of acidity/alkalinity and
         extractable metals
    B. Test method for air leakage past syringe piston
         during aspiration
    C. Test method for force required to operate plunger
    D. Properties of needles with external diameter less
         than 0,45 mm
    E. Test method for determination of dead space
    F. Test method for liquid leakage at syringe piston
         and syringe nozzle/hub or needle/barrel unions
         during compression
    G. Test method for air leakage past nozzle/hub or
         needle/barrel unions during aspiration
    H. Preparation of extract for test for pyrogenicity
         and toxicity
    J. Symbol for 'do not re-use'
    Tables
    1. Insulin syringes, range of sizes, graduated scale
         and tolerance on graduated capacity
    2. Maximum dead space
    D.1 Diameter of needle tube
    D.2 Stiffness
    D.3 Minimum strength of bond between hub/syringe and
         needle tube
    D.4 Size of stylet to test patency of lumen
    D.5 Resistance to breakage
    Figures
    1. Schematic representation of insulin syringe for
         single use
    B.1 Apparatus used in aspiration tests
    J.1 ISO symbol for single use, number ISO 7000/1051

    Abstract - (Show below) - (Hide below)

    Describes requirements and test methods for sterile syringes with or without needles for single use solely for the injection of insulin in humans. Covers syringes for use with 40 units of insulin/ml and 100 units of insulin/ml. Intended for use soon after filling as they are not suitable for containing insulin over extended periods of time. Covers normative references, definitions and nomenclature, types of syringe, freedom from extraneous matter, limits for extractable matter, lubrication of syringes and needles, range of sizes, graduated scale, barrel, piston/plunger assembly, nozzle, needles, performance of assembled syringe packaging and marking.

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

    Committee CTN 111
    Development Note Supersedes UNE 53372. (09/2003)
    Document Type Standard
    Publisher Asociacion Espanola de Normalizacion
    Status Current
    Supersedes

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

    NF EN ISO 80369-7 : 2017 SMALL-BORE CONNECTORS FOR LIQUIDS AND GASES IN HEALTHCARE APPLICATIONS - PART 7: CONNECTORS FOR INTRAVASCULAR OR HYPODERMIC APPLICATIONS
    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 9626:2016 Stainless steel needle tubing for the manufacture of medical devices — Requirements and test methods
    ISO 11608-5:2012 Needle-based injection systems for medical use Requirements and test methods Part 5: Automated functions
    ISO 11608-1:2014 Needle-based injection systems for medical use Requirements and test methods Part 1: Needle-based injection systems
    EN ISO 7864:2016 Sterile hypodermic needles for single use - Requirements and test methods (ISO 7864:2016)
    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
    EN ISO 14971:2012 Medical devices - Application of risk management to medical devices (ISO 14971:2007, Corrected version 2007-10-01)
    ISO 80369-7:2016 Small-bore connectors for liquids and gases in healthcare applications Part 7: Connectors for intravascular or hypodermic applications
    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 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
    EN ISO 10993-1:2009/AC:2010 BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 1: EVALUATION AND TESTING WITHIN A RISK MANAGEMENT PROCESS (ISO 10993-1:2009/COR 1:2010)
    EN ISO 9626:2016 Stainless steel needle tubing for the manufacture of medical devices - Requirements and test methods (ISO 9626:2016)
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