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  • EN ISO 8536-4:2013/A1:2013

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    Superseded A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
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    INFUSION EQUIPMENT FOR MEDICAL USE - PART 4: INFUSION SETS FOR SINGLE USE, GRAVITY FEED (ISO 8536-4:2010/AMD 1:2013)

    Available format(s): 

    Superseded date:  05-02-2020

    Language(s): 

    Published date:  06-03-2013

    Publisher:  Comite Europeen de Normalisation

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

    Foreword
    1 Scope
    2 Normative references
    3 General requirements
    4 Designation
    5 Materials
    6 Physical requirements
    7 Chemical requirements
    8 Biological requirements
    9 Labelling
    10 Packaging
    Annex A (normative) - Physical tests
    Annex B (normative) - Chemical tests
    Annex C (normative) - Biological tests
    Bibliography
    Annex ZA (informative) - Relationship between this
             European Standard and the Essential
             Requirements of EU Directive 93/42/EEC

    Abstract - (Show below) - (Hide below)

    Describes requirements for single use, gravity feed infusion sets for medical use in order to ensure their compatibility with containers for infusion solutions and intravenous equipment.

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

    Committee TC 205
    Document Type Standard
    Publisher Comite Europeen de Normalisation
    Status Superseded
    Superseded By

    Standards Referenced By This Book - (Show below) - (Hide below)

    I.S. EN 60601-2-24:2015 MEDICAL ELECTRICAL EQUIPMENT - PART 2-24: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF INFUSION PUMPS AND CONTROLLERS
    BS EN ISO 8536-13:2016 Infusion equipment for medical use Graduated flow regulators for single use with fluid contact
    I.S. EN ISO 8536-13:2016 INFUSION EQUIPMENT FOR MEDICAL USE - PART 13: GRADUATED FLOW REGULATORS FOR SINGLE USE WITH FLUID CONTACT (ISO 8536-13:2016)
    I.S. EN ISO 8536-10:2015 INFUSION EQUIPMENT FOR MEDICAL USE - PART 10: ACCESSORIES FOR FLUID LINES FOR SINGLE USE WITH PRESSURE INFUSION EQUIPMENT (ISO 8536-10:2015)
    CEI EN 60601-2-24 : 2016 MEDICAL ELECTRICAL EQUIPMENT - PART 2-24: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF INFUSION PUMPS AND CONTROLLERS
    BS EN ISO 8536-10:2015 Infusion equipment for medical use Accessories for fluid lines for single use with pressure infusion equipment
    UNE-EN ISO 8536-8:2015 Infusion equipment for medical use - Part 8: Infusion sets for single use with pressure infusion apparatus (ISO 8536-8:2015)
    EN ISO 3826-4:2015 Plastics collapsible containers for human blood and blood components - Part 4: Aphaeresis blood bag systems with integrated features (ISO 3826-4:2015)
    UNE-EN ISO 8536-13:2017 Infusion equipment for medical use - Part 13: Graduated flow regulators for single use with fluid contact (ISO 8536-13:2016)
    BS EN ISO 3826-4:2015 Plastics collapsible containers for human blood and blood components Aphaeresis blood bag systems with integrated features
    ISO 8536-10:2015 Infusion equipment for medical use Part 10: Accessories for fluid lines for single use with pressure infusion equipment
    ISO 8536-13:2016 Infusion equipment for medical use Part 13: Graduated flow regulators for single use with fluid contact
    UNE-EN ISO 8536-10:2015 Infusion equipment for medical use - Part 10: Accessories for fluid lines for single use with pressure infusion equipment (ISO 8536-10:2015)
    EN ISO 8536-13:2016 Infusion equipment for medical use - Part 13: Graduated flow regulators for single use with fluid contact (ISO 8536-13:2016)
    EN ISO 8536-10:2015 Infusion equipment for medical use - Part 10: Accessories for fluid lines for single use with pressure infusion equipment (ISO 8536-10:2015)
    BS EN 60601-2-24:2015 Medical electrical equipment Particular requirements for the basic safety and essential performance of infusion pumps and controllers
    I.S. EN ISO 3826-4:2015 PLASTICS COLLAPSIBLE CONTAINERS FOR HUMAN BLOOD AND BLOOD COMPONENTS - PART 4: APHAERESIS BLOOD BAG SYSTEMS WITH INTEGRATED FEATURES (ISO 3826-4:2015)
    ISO 3826-4:2015 Plastics collapsible containers for human blood and blood components — Part 4: Aphaeresis blood bag systems with integrated features
    EN 60601-2-24:2015 Medical electrical equipment - Part 2-24: Particular requirements for the basic safety and essential performance of infusion pumps and controllers

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

    ISO 10993-4:2017 Biological evaluation of medical devices — Part 4: Selection of tests for interactions with blood
    ISO 80000-4:2006 Quantities and units Part 4: Mechanics
    ISO/TS 17665-2:2009 Sterilization of health care products — Moist heat — Part 2: Guidance on the application of ISO 17665-1
    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 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 291:2008 Plastics Standard atmospheres for conditioning and testing
    ISO 14644-1:2015 Cleanrooms and associated controlled environments Part 1: Classification of air cleanliness by particle concentration
    ISO 3696:1987 Water for analytical laboratory use — Specification and test methods
    ISO/TS 11135-2:2008 Sterilization of health care products Ethylene oxide Part 2: Guidance on the application of ISO 11135-1
    ISO 7000:2014 Graphical symbols for use on equipment Registered symbols
    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
    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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