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    ISO 20696:2018

    Current The latest, up-to-date edition.

    Sterile urethral catheters for single use

    Available format(s):  Hardcopy, PDF, PDF 3 Users, PDF 5 Users, PDF 9 Users

    Language(s):  English, French

    Published date:  05-06-2018

    Publisher:  International Organization for Standardization

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    Abstract - (Show below) - (Hide below)

    This document specifies requirements and test methods for sterile urethral catheters for single use, with or without a balloon.

    This document does not include drainage catheters covered by ISO 20697, e.g. ureteral catheters, nephrostomy catheters, and suprapubic catheters. This document also excludes ureteral stents.

    NOTE Ureteral stents are covered in ASTM F1828‑97.

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

    Committee ISO/TC 84
    Development Note Supersedes ISO/DIS 20696. (06/2018)
    Document Type Standard
    Product Note THIS STANDARD HAVE CORRECTED VERSION FOR ENGLISH AND FRENCH 2018
    Publisher International Organization for Standardization
    Status Current

    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 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
    ISO/TR 19244:2014 Guidance on transition periods for standards developed by ISO/TC 84 — Devices for administration of medicinal products and catheters
    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
    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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