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  • UNI EN ISO 11070 : 2015

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    Superseded A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
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    STERILE SINGLE-USE INTRAVASCULAR INTRODUCERS, DILATORS AND GUIDEWIRES

    Available format(s): 

    Superseded date:  29-08-2022

    Language(s): 

    Published date:  01-01-2015

    Publisher:  Ente Nazionale Italiano di Unificazione (UNI)

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

    Foreword
    Introduction
    1 Scope
    2 Normative references
    3 Terms and definitions
    4 General requirements
    5 Additional requirements for introducer needles
    6 Additional requirements for introducer catheters
    7 Additional requirements for sheath introducers
    8 Additional requirements for guidewires
    9 Additional requirements for dilators
    10 Additional requirements for kits containing
       combinations of devices specified in this
       International Standard
    Annex A (informative) - Guidance on materials
            and design
    Annex B (normative) - Test method for corrosion
            resistance
    Annex C (normative) - Method for determining
            peak tensile force of introducer catheters,
            sheath introducers, and dilators
    Annex D (normative) - Test method for liquid
            leakage from sheath introducers under
            pressure
    Annex E (normative) - Test method for liquid
            leakage through haemostasis valves of
            sheath introducers
    Annex F (normative) - Test method for fracture
            of guidewires
    Annex G (normative) - Test method for resistance
            of guidewires to damage by flexing
    Annex H (normative) - Method for determining
            peak tensile force of guidewires
    Annex I (normative) - Determination of strength
            of union of needle hub and needle
    Bibliography

    Abstract - (Show below) - (Hide below)

    Defines requirements for introducer needles, introducer catheters, sheath introducers, guidewires, and dilators supplied in the sterile condition, and intended for single use in conjunction with intravascular catheters specified in ISO 10555-1.

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

    Committee U42.01
    Document Type Standard
    Publisher Ente Nazionale Italiano di Unificazione (UNI)
    Status Superseded
    Superseded By
    Supersedes

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

    DIN 13273-7:2003-08 CATHETER FOR MEDICAL USE - PART 7: DETERMINATION OF THE X-RAY ATTENUATION OF CATHETERS - REQUIREMENTS AND TESTING
    ISO 9626:2016 Stainless steel needle tubing for the manufacture of medical devices — Requirements and test methods
    ISO 7886-1:2017 Sterile hypodermic syringes for single use — Part 1: Syringes for manual use
    ISO 8601:2004 Data elements and interchange formats Information interchange Representation of dates and times
    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
    ISO 10555-3:2013 Intravascular catheters — Sterile and single-use catheters — Part 3: Central venous catheters
    ISO 10555-1:2013 Intravascular catheters — Sterile and single-use catheters — Part 1: General requirements
    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 594-1:1986 Conical fittings with a 6 % (Luer) taper for syringes, needles and certain other medical equipment Part 1: General requirements
    ISO 10555-5:2013 Intravascular catheters — Sterile and single-use catheters — Part 5: Over-needle peripheral catheters
    ASTM F 640 : 2012 : REDLINE Standard Test Methods for Determining Radiopacity for Medical Use
    ISO 10555-4:2013 Intravascular catheters — Sterile and single-use catheters — Part 4: Balloon dilatation catheters
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