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  • EN ISO 10555-1:2013/A1:2017

    Current The latest, up-to-date edition.

    INTRAVASCULAR CATHETERS - STERILE AND SINGLE-USE CATHETERS - PART 1: GENERAL REQUIREMENTS (ISO 10555-1:2013/AMD 1:2017)

    Available format(s): 

    Language(s): 

    Published date:  20-12-2017

    Publisher:  Comite Europeen de Normalisation

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

    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
    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)

    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)

    Committee CEN/TC 205
    Development Note Supersedes EN ISO 10555-2. (10/2013)
    Document Type Standard
    Publisher Comite Europeen de Normalisation
    Status Current
    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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