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  • 14/30296389 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    Superseded A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.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 7864 - STERILE HYPODERMIC NEEDLES FOR SINGLE USE - REQUIREMENTS AND TEST METHODS

    Available format(s):  Hardcopy, PDF

    Superseded date:  30-09-2016

    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 Requirements
    5 Packaging
    6 Information supplied by the manufacturer
    Annex A (normative) - Method for preparation
            of extracts
    Annex B (informative) - Fragmentation Test for
            Medical Needles
    Annex C (informative) - Determination of flow rate
            through the needle
    Annex D (informative) - Test method for measuring
            the penetration force and drag force for needles
    Annex E (informative) - Needle bonding strength test method
    Bibliography
    Annex ZA (informative) - Relationship between this
             European Standard and the Essential Requirements
             of EU Directive 93/42/EEC amended by Directive
             2007/47/EEC

    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    Status Superseded
    Superseded By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 8362-2:2015 Injection containers and accessories — Part 2: Closures for injection vials
    ISO 8537:2016 Sterile single-use syringes, with or without needle, for insulin
    ISO 9626:2016 Stainless steel needle tubing for the manufacture of medical devices — Requirements and test methods
    ISO 8362-4:2011 Injection containers and accessories Part 4: Injection vials made of moulded glass
    ISO 8601:2004 Data elements and interchange formats Information interchange Representation of dates and times
    ISO 8362-3:2001 Injection containers and accessories Part 3: Aluminium caps for injection vials
    ISO 10993-1:2009 Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process
    ISO 80369-1:2010 Small-bore connectors for liquids and gases in healthcare applications Part 1: General requirements
    ISO 8362-1:2009 Injection containers and accessories Part 1: Injection vials made of glass tubing
    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 7000:2014 Graphical symbols for use on equipment Registered symbols
    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 6009:2016 Hypodermic needles for single use Colour coding for identification
    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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