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  • BS ISO 28620:2010

    View superseded by
    Superseded A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
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    Medical devices. Non-electrically driven portable infusion devices

    Available format(s):  Hardcopy, PDF

    Superseded date:  20-01-2020

    Language(s):  English

    Published date:  28-02-2010

    Publisher:  British Standards Institution

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

    Foreword
    1 Scope
    2 Normative references
    3 Terms and definitions
    4 General requirements
    5 Operating requirements
    6 Test methods
    7 Information to be listed on packaging and/or product
    8 Accompanying documents
    Bibliography

    Abstract - (Show below) - (Hide below)

    Describes essential requirements and related test methods for non-electrically driven portable infusion devices.

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

    Committee CH/212
    Development Note Supersedes 08/30170025 DC. (09/2010)
    Document Type Standard
    Publisher British Standards Institution
    Status Superseded
    Superseded By
    Supersedes

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

    ISO 14937:2009 Sterilization of health care products General requirements for characterization of a sterilizing agent and the development, validation and routine control of a sterilization process for medical devices
    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
    EN 1041:2008+A1:2013 Information supplied by the manufacturer of medical devices
    ISO 10555-1:2013 Intravascular catheters — Sterile and single-use catheters — Part 1: General requirements
    IEC 60601-2-24:2012 Medical electrical equipment - Part 2-24: Particular requirements for the basic safety and essential performance of infusion pumps and controllers
    ISO 554:1976 Standard atmospheres for conditioning and/or testing — Specifications
    ISO 11607-1:2006 Packaging for terminally sterilized medical devices Part 1: Requirements for materials, sterile barrier systems and packaging systems
    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
    EN 13868:2002 Catheters - Test methods for kinking of single lumen catheters and medical tubing
    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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