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    I.S. EN ISO 7864:2016

    Current The latest, up-to-date edition.

    STERILE HYPODERMIC NEEDLES FOR SINGLE USE - REQUIREMENTS AND TEST METHODS (ISO/DIS 7864:2014)

    Available format(s):  Hardcopy, PDF

    Language(s):  English

    Published date:  01-01-2016

    Publisher:  National Standards Authority of Ireland

    For Harmonized Standards, check the EU site to confirm that the Standard is cited in the Official Journal.
    Only cited Standards give presumption of conformance to New Approach Directives/Regulations.

    Dates of withdrawal of national standards are available from NSAI.

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

    National Foreword
    European foreword
    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 [OJ L 169] aimed to be
             covered

    Abstract - (Show below) - (Hide below)

    Defines requirements for sterile hypodermic needles for single use of designated metric sizes 0,18 mm to 1,2 mm.

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

    Document Type Standard
    Publisher National Standards Authority of Ireland
    Status Current
    Supersedes

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

    ISO 8362-7:2006 Injection containers and accessories Part 7: Injection caps made of aluminium-plastics combinations without overlapping plastics part
    EN ISO 23908:2013 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 23908:2011)
    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 80369-20:2015 Small-bore connectors for liquids and gases in healthcare applications Part 20: Common test methods
    ISO 9626:2016 Stainless steel needle tubing for the manufacture of medical devices — Requirements and test methods
    ISO/TR 19244:2014 Guidance on transition periods for standards developed by ISO/TC 84 — Devices for administration of medicinal products and catheters
    EN ISO 80369-1:2010 Small bore connectors for liquids and gases in healthcare applications - Part 1: General requirements (ISO 80369-1:2010)
    EN ISO 6009:2016 Hypodermic needles for single use - Colour coding for identification (ISO 6009:2016)
    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 8362-6:2010 Injection containers and accessories Part 6: Caps made of aluminium-plastics combinations for injection vials
    ISO 8362-5:2016 Injection containers and accessories Part 5: Freeze drying closures 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
    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
    EN ISO 3696:1995 Water for analytical laboratory use - Specification and test methods (ISO 3696:1987)
    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 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
    EN 20594-1:1993/A1:1997 CONICAL FITTINGS WITH A 6% (LUER) TAPER FOR SYRINGES, NEEDLES AND CERTAIN OTHER MEDICAL EQUIPMENT - GENERAL REQUIREMENTS
    ISO 6009:2016 Hypodermic needles for single use Colour coding for identification
    EN 1707 : 1996 CONICAL FITTINGS WITH A 6 % (LUER) TAPER FOR SYRINGES, NEEDLES AND CERTAIN OTHER MEDICAL EQUIPMENT - LOCK FITTINGS
    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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