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  • ISO 8536-13:2016

    Current The latest, up-to-date edition.

    Infusion equipment for medical use Part 13: Graduated flow regulators for single use with fluid contact

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

    Language(s):  English, French

    Published date:  27-09-2016

    Publisher:  International Organization for Standardization

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    Abstract - (Show below) - (Hide below)

    ISO 8536-13:2016 specifies requirements for non-sterile, single-use graduated flow regulators used as subcomponents in sterilized infusion sets for single use to control the flow of intravenous infusion solutions with fluid contact under gravity feed conditions.

    In some countries, the national pharmacopoeia or other national regulations are legally binding and take precedence over ISO 8536-13:2016.

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

    Development Note Supersedes ISO/DIS 8536-13. (09/2016)
    Document Type Standard
    Publisher International Organization for Standardization
    Status Current

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

    ISO 80000-4:2006 Quantities and units Part 4: Mechanics
    EN ISO 8536-4:2013/A1:2013 INFUSION EQUIPMENT FOR MEDICAL USE - PART 4: INFUSION SETS FOR SINGLE USE, GRAVITY FEED (ISO 8536-4:2010/AMD 1:2013)
    ISO 8536-4:2010 Infusion equipment for medical use Part 4: Infusion sets for single use, gravity feed
    ISO 10993-1:2009 Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process
    EN ISO 10993-1:2009/AC:2010 BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 1: EVALUATION AND TESTING WITHIN A RISK MANAGEMENT PROCESS (ISO 10993-1:2009/COR 1:2010)
    EN ISO 80000-4:2013 Quantities and units - Part 4: Mechanics (ISO 80000-4:2006)
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