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  • DIN EN ISO 3826-4 E : 2015

    Current The latest, up-to-date edition.

    PLASTICS COLLAPSIBLE CONTAINERS FOR HUMAN BLOOD AND BLOOD COMPONENTS - PART 4: APHERESIS BLOOD BAG SYSTEMS WITH INTEGRATED FEATURES (ISO 3826-4:2015)

    Available format(s):  Hardcopy, PDF

    Language(s):  English

    Published date:  01-01-2015

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

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

    National foreword
    National Annex NA (informative) - Bibliography
    European foreword
    Introduction
    1 Scope
    2 Normative references
    3 Terms and definitions
    4 Dimensions
    5 Design
    6 Requirements
    7 Packaging
    8 Labelling
    9 Anticoagulant and/or preservative solution
    Annex A (normative) - Chemical tests
    Annex B (normative) - Physical tests
    Annex C (normative) - Biological tests
    Annex ZA (informative) - Relationship between
             this European Standard and the Essential
             Requirements of EU Directive 93/42/EEC
             on Medical devices
    Bibliography

    Abstract - (Show below) - (Hide below)

    Defines requirements including performance requirements for aphaeresis blood bag systems with integrated features.

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

    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 3826-3:2006 Plastics collapsible containers for human blood and blood components — Part 3: Blood bag systems with integrated features
    ISO 3826-1:2013 Plastics collapsible containers for human blood and blood components Part 1: Conventional containers
    ISO 10993-10:2010 Biological evaluation of medical devices Part 10: Tests for irritation and skin sensitization
    ISO 10993-11:2017 Biological evaluation of medical devices — Part 11: Tests for systemic toxicity
    ISO 10993-12:2012 Biological evaluation of medical devices Part 12: Sample preparation and reference materials
    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
    DIN EN ISO 10993-12 E : 2012 BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 12: SAMPLE PREPARATION AND REFERENCE MATERIALS (ISO 10993-12:2012)
    ISO 1135-4:2015 Transfusion equipment for medical use — Part 4: Transfusion sets for single use, gravity feed
    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
    DIN EN ISO 10993-11 E : 2009 BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 11: TESTS FOR SYSTEMIC TOXICITY
    ISO 3696:1987 Water for analytical laboratory use — Specification and test methods
    ISO 23908:2011 Sharps injury protection Requirements and test methods Sharps protection features for single-use hypodermic needles, introducers for catheters and needles used for blood sampling
    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
    DIN ISO 3696:1991-06 WATER FOR ANALYTICAL LABORATORY USE - SPECIFICATION AND TEST METHODS
    ISO 15747:2010 Plastic containers for intravenous injections
    DIN EN ISO 10993-10 E : 2003 BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 10: TESTS FOR IRRITATION AND SKIN SENSITIZATION (ISO 10993-10:2010)
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