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  • DIN EN ISO 1135-3 E : 2017

    Current The latest, up-to-date edition.

    TRANSFUSION EQUIPMENT FOR MEDICAL USE - PART 3: BLOOD-TAKING SETS FOR SINGLE USE (ISO 1135-3:2016)

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    Published date:  29-05-2017

    Publisher:  German Institute for Standardisation (Deutsches Institut für Normung)

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

    National foreword<br>National Annex NA (informative) - Bibliography<br>European foreword<br>Foreword <br>1 Scope<br>2 Normative references<br>3 General requirements<br>4 Materials<br>5 Physical requirements<br>6 Chemical requirements<br>7 Biological requirements<br>8 Labelling<br>9 Packaging<br>10 Disposal<br>Annex A (normative) - Physical tests<br>Annex B (normative) - Chemical tests<br>Annex C (normative) - Biological tests<br>Bibliography<br>Annex ZA (informative) - Relationship between<br>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;this European standard and the essential<br>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;requirements of Directive 93/42/EEC<br>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;[OJ L 169] aimed to be covered<br>Bibliography

    Abstract - (Show below) - (Hide below)

    Gives requirements for types of blood-taking sets for medical use in order to ensure functional interchangeability of transfusion equipment.

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    Document Type Standard
    Publisher German Institute for Standardisation (Deutsches Institut für Normung)
    Status Current

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

    ISO 3826-2:2008 Plastics collapsible containers for human blood and blood components — Part 2: Graphical symbols for use on labels and instruction leaflets
    ISO 10993-4:2017 Biological evaluation of medical devices — Part 4: Selection of tests for interactions with blood
    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
    ISO 9626:2016 Stainless steel needle tubing for the manufacture of medical devices — Requirements and test methods
    DIN 13097-4:2009-08 HYPODERMIC NEEDLES - PART 4: POINT GEOMETRY, REQUIREMENTS AND TESTING
    DIN EN ISO 8536-14:2015-08 (Draft) INFUSION EQUIPMENT FOR MEDICAL USE - PART 14: CLAMPS AND FLOW REGULATORS FOR TRANSFUSION AND INFUSION EQUIPMENT WITHOUT FLUID CONTACT (ISO 8536-14:2016)
    ISO 1773:1997 Laboratory glassware Narrow-necked boiling flasks
    DIN EN 80416-1:2009-11 BASIC PRINCIPLES FOR GRAPHICAL SYMBOLS FOR USE ON EQUIPMENT - PART 1: CREATION OF GRAPHICAL SYMBOLS FOR REGISTRATION
    EN ISO 7864:2016 Sterile hypodermic needles for single use - Requirements and test methods (ISO 7864:2016)
    DIN EN ISO 291 E : 2008 PLASTICS - STANDARD ATMOSPHERES FOR CONDITIONING AND TESTING
    DIN EN ISO 9626 E : 2016 STAINLESS STEEL NEEDLE TUBING FOR THE MANUFACTURE OF MEDICAL DEVICES - REQUIREMENTS AND TEST METHODS (ISO 9626:2016)
    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
    IEC 80416-1:2008 Basic principles for graphical symbols for use on equipment - Part 1: Creation of graphical symbols for registration
    ISO 14644-1:2015 Cleanrooms and associated controlled environments Part 1: Classification of air cleanliness by particle concentration
    DIN EN ISO 3826-2:2008-11 PLASTICS COLLAPSIBLE CONTAINERS FOR HUMAN BLOOD AND BLOOD COMPONENTS - PART 2: GRAPHICAL SYMBOLS FOR USE ON LABELS AND INSTRUCTION LEAFLETS
    ISO 3696:1987 Water for analytical laboratory use — Specification and test methods
    EN ISO 3696:1995 Water for analytical laboratory use - Specification and test methods (ISO 3696:1987)
    DIN 13097-5:2008-11 HYPODERMIC NEEDLES - PART 5: SOCKETS, HUBS AND CONNECTIONS - REQUIREMENTS AND TESTING
    ISO 7000:2014 Graphical symbols for use on equipment Registered symbols
    ISO 11607-1:2006 Packaging for terminally sterilized medical devices Part 1: Requirements for materials, sterile barrier systems and packaging systems
    ISO 8536-14:2016 Infusion equipment for medical use Part 14: Clamps and flow regulators for transfusion and infusion equipment without fluid contact
    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 ISO 14644-1:2015 Cleanrooms and associated controlled environments - Part 1: Classification of air cleanliness by particle concentration (ISO 14644-1:2015)
    DIN ISO 3696:1991-06 WATER FOR ANALYTICAL LABORATORY USE - SPECIFICATION AND TEST METHODS
    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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