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    I.S. EN ISO 10555-1:2013

    View superseded by
    Superseded A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
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    INTRAVASCULAR CATHETERS - STERILE AND SINGLE-USE CATHETERS - PART 1: GENERAL REQUIREMENTS (ISO 10555-1:2013/AMD 1:2017)

    Available format(s):  Hardcopy, PDF

    Superseded date:  07-12-2023

    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)

    National Foreword
    European Foreword
    Foreword
    1 Scope
    2 Normative references
    3 Terms and definitions
    4 Requirements
    5 Designation of nominal size
    6 Information to be supplied by the manufacturer
    Annex A (normative) - Test method for corrosion
            resistance
    Annex B (normative) - Method for determining peak
            tensile force
    Annex C (normative) - Test method for liquid leakage
            under pressure
    Annex D (normative) - Test method for air leakage
            into hub assembly during aspiration
    Annex E (normative) - Determination of flowrate
            through catheter
    Annex F (normative) - Test for burst pressure under
            static conditions
    Annex G (normative) - Power injection test for
            flowrate and device pressure(only for products
            indicated for power injection)
    Annex H (informative) - Units of measurement systems
            other than those specified in this part of
            ISO 10555, which may additionally be used
    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)

    Describes general requirements for intravascular catheters, supplied in the sterile condition and intended for single use, for any application.

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

    Development Note Supersedes I.S. EN ISO 10555-2. (10/2013)
    Document Type Standard
    Publisher National Standards Authority of Ireland
    Status Superseded
    Superseded By
    Supersedes

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

    ISO 11137-1:2006 Sterilization of health care products Radiation Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices
    ISO 11607-2:2006 Packaging for terminally sterilized medical devices Part 2: Validation requirements for forming, sealing and assembly processes
    ISO 11135-1:2007 Sterilization of health care products Ethylene oxide Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices
    ISO 7886-1:2017 Sterile hypodermic syringes for single use — Part 1: Syringes for manual use
    ISO/TS 12417:2011 Cardiovascular implants and extracorporeal systems Vascular device-drug combination products
    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 80369-7:2016 Small-bore connectors for liquids and gases in healthcare applications Part 7: Connectors for intravascular or hypodermic applications
    ISO 14971:2007 Medical devices Application of risk management to medical devices
    ISO 11607-1:2006 Packaging for terminally sterilized medical devices Part 1: Requirements for materials, sterile barrier systems and packaging systems
    ISO 3105:1994 Glass capillary kinematic viscometers — Specifications and operating instructions
    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 17665-1:2006 Sterilization of health care products — Moist heat — Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices
    ASTM F 640 : 2012 : REDLINE Standard Test Methods for Determining Radiopacity for Medical Use
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