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  • ISO 10555-6:2015

    Current The latest, up-to-date edition.

    Intravascular catheters Sterile and single-use catheters Part 6: Subcutaneous implanted ports

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

    Language(s):  English, French

    Published date:  15-04-2015

    Publisher:  International Organization for Standardization

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    Abstract - (Show below) - (Hide below)

    ISO 10555-6:2015 specifies requirements, performance, and user safety issues related to subcutaneous implanted ports and catheters for intravascular long-term use supplied in sterile condition and intended for single use.

    ISO 10555-6:2015 does not specify requirements, performance, and user safety issues related to non-coring needles.

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

    Development Note Supersedes ISO/DIS 10555-6. (04/2015) NEW CHILD CREATE AMD1
    Document Type Standard
    Product Note NEW CHILD CREATE AMD1
    Publisher International Organization for Standardization
    Status Current

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

    ISO 5832-1:2016 Implants for surgery — Metallic materials — Part 1: Wrought stainless steel
    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 9584:1993 Implants for surgery — Non-destructive testing — Radiographic examination of cast metallic surgical implants
    ISO 6474-1:2010 Implants for surgery Ceramic materials Part 1: Ceramic materials based on high purity alumina
    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 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 5832-2:1999 Implants for surgery Metallic materials Part 2: Unalloyed titanium
    ISO 10555-1:2013 Intravascular catheters — Sterile and single-use catheters — Part 1: General requirements
    ISO 48:2010 Rubber, vulcanized or thermoplastic Determination of hardness (hardness between 10 IRHD and 100 IRHD)
    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
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