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  • BS EN ISO 8537:2016

    Current The latest, up-to-date edition.

    Sterile single-use syringes, with or without needle, for insulin

    Available format(s):  Hardcopy, PDF

    Language(s):  English

    Published date:  30-04-2016

    Publisher:  British Standards Institution

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    This International Standard specifies requirements and test methods for empty, sterile, single-use syringes, with or without needles, made of plastic materials and intended solely for the injection of insulin, with which the syringes are filled by the end user. This International Standard covers syringes intended for single-use only in humans and with insulins of various concentrations.

    The insulin syringes specified in this International Standard are intended for use (i.e. insulin injection) immediately after filling and are not intended to contain insulin for extended periods of time.

    This International Standard excludes single-use syringes made of glass, syringes for use with power-driven syringe pumps, syringes that are pre-filled by the manufacturer, and syringes intended to be stored after filling (e.g. in a kit intended for filling by a pharmacist).

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    Committee CH/84
    Development Note Renumbers and supersedes BS 7548(1992). 1995 version incorporates amendment 8538 to BS 7548(1992). Supersedes 87/54650 DC and 98/560722 DC. (04/2005) Supersedes 06/30141618 DC. (10/2008) Supersedes 14/30294895 DC.(05/2016)
    Document Type Standard
    Publisher British Standards Institution
    Status Current
    Supersedes

    Standards Referenced By This Book - (Show below) - (Hide below)

    BS 5081-2(1993) : 1993 AMD 9104 STERILE HYPODERMIC SYRINGES AND NEEDLES - SPECIFICATION FOR STERILE HYPODERMIC NEEDLES FOR SINGLE USE

    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 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 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 80369-7:2017 Small-bore connectors for liquids and gases in healthcare applications - Part 7: Connectors for intravascular or hypodermic applications (ISO 80369-7:2016, Corrected version 2016-12-01)
    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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