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    I.S. 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 (ISO 10555-5:2013)

    Available format(s):  Hardcopy, PDF

    Language(s):  English

    Published date:  01-01-2013

    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)

    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
    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

    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)

    Document Type Standard
    Publisher National Standards Authority of Ireland
    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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