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  • UNI EN ISO 10555-5 : 2013

    Current The latest, up-to-date edition.

    INTRAVASCULAR CATHETERS - STERILE AND SINGLE-USE CATHETERS - PART 5: OVER-NEEDLE PERIPHERAL CATHETERS

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    Published date:  19-09-2013

    Publisher:  Ente Nazionale Italiano di Unificazione (UNI)

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

    Foreword
    1 Scope
    2 Normative references
    3 Terms and definitions
    4 Requirements
    Annex A (normative) - Determination of strength of
            union of needle hub and needle tube
    Annex B (informative) - Colours for opaque catheter
            hubs
    Annex C (informative) - Needle point geometries
    Annex D (normative) - Determination of liquid leakage
            from vent fitting
    Annex ZA (informative) - Relationship between this
             European Standard and the Essential
             Requirements of EU Directive 93/42/EEC
             amended by Directive 2007/47/EEC
    Bibliography

    Abstract - (Show below) - (Hide below)

    Defines requirements for over-needle peripheral intravascular catheters, intended for accessing the peripheral vascular system, supplied in the sterile condition and intended for single use.

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

    Committee CT 44
    Document Type Standard
    Publisher Ente Nazionale Italiano di Unificazione (UNI)
    Status Current
    Supersedes

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

    ISO 11070:2014 Sterile single-use intravascular introducers, dilators and guidewires
    ISO 9626:2016 Stainless steel needle tubing for the manufacture of medical devices — Requirements and test methods
    NFX 08 002 : 1983 FD LIMITED COLLECTION OF COLOURS - DESIGNATION AND CATALOGUE OF CCR COLOURS - SECONDARY STANDARDS
    DIN 6164-1:1980-02 DIN COLOUR CHART; SYSTEM BASED ON THE 2 DEGREE STANDARD COLORIMETRIC OBSERVER
    ISO 7864:2016 Sterile hypodermic needles for single use — Requirements and test methods
    ISO 10555-1:2013 Intravascular catheters — Sterile and single-use catheters — Part 1: General requirements
    ISO 14972:1998 Sterile obturators for single use with over-needle peripheral intravascular catheters
    ISO 594-1:1986 Conical fittings with a 6 % (Luer) taper for syringes, needles and certain other medical equipment Part 1: General requirements
    FED-STD-595 Revision C:2008 COLORS USED IN GOVERNMENT PROCUREMENT
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