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  • 17/30336573 DC : 0

    NA Status of Standard is Unknown

    BS EN ISO 20696 - STERILE URETHAL CATHETERS FOR SINGLE USE

    Available format(s):  Hardcopy, PDF

    Language(s):  English

    Published date: 

    Publisher:  British Standards Institution

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

    Foreword
    Introduction
    1 Scope
    2 Normative references
    3 Terms and definitions
    4 Intended performance
    5 General requirements
    6 Specific requirements
    7 Information to be supplied by the manufacturer
    Annex A (normative) - Test method for determining
            the strength of the catheter
    Annex B (normative) - Test method for determining
            the security of fit of the drainage funnel
    Annex C (normative) - Test method for determining
            balloon security
    Annex D (normative) - Test method for determining
            inflation lumen leakage and/or function and/or
            balloon deflation (catheter with compliance
            balloon)
    Annex E (normative) - Test method for determination
            of flow rate through catheter
    Annex F (normative) - Test method for corrosion
            resistance
    Annex G (normative) - Test method for determining
            kink stability
    Annex H (normative) - Test method for determining
            peak tensile force of urethral catheter
    Annex I (normative) - Test method for determining
            balloon size deflation reliability
            (catheter with non-compliant balloon)
    Annex J (normative) - Test method for determining
            inflated balloon resistance to traction
    Bibliography

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

    Comment Closes On
    Committee CH/84
    Document Type Draft
    Publisher British Standards Institution
    Status NA

    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 11135:2014 Sterilization of health-care products Ethylene oxide Requirements for the development, validation and routine control of a sterilization process for medical devices
    ASTM F 1842 : 2015 : REDLINE Standard Test Method for Determining Ink or Coating Adhesion on Flexible Substrates for a Membrane Switch or Printed Electronic Device
    EN 1041:2008+A1:2013 Information supplied by the manufacturer of medical devices
    ASTM F 2052 : 2015 : REDLINE Standard Test Method for Measurement of Magnetically Induced Displacement Force on Medical Devices in the Magnetic Resonance Environment
    ASTM F 2213 : 2017 : REDLINE Standard Test Method for Measurement of Magnetically Induced Torque on Medical Devices in the Magnetic Resonance Environment
    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 14155:2011 Clinical investigation of medical devices for human subjects Good clinical practice
    ASTM F 1828 : 2017 : REDLINE Standard Specification for Ureteral Stents
    ISO 14971:2007 Medical devices Application of risk management to medical devices
    ISO 15223-1:2016 Medical devices Symbols to be used with medical device labels, labelling and information to be supplied Part 1: General requirements
    EN 980:2008 Symbols for use in the labelling of medical devices
    ASTM F 640 : 2012 : REDLINE Standard Test Methods for Determining Radiopacity for Medical Use
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