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    I.S. EN ISO 3826-4:2015

    Current The latest, up-to-date edition.

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

    Available format(s):  Hardcopy, PDF

    Language(s):  English

    Published date:  01-01-2015

    Publisher:  National Standards Authority of Ireland

    For Harmonized Standards, check the EU site to confirm that the Standard is cited in the Official Journal.
    Only cited Standards give presumption of conformance to New Approach Directives/Regulations.

    Dates of withdrawal of national standards are available from NSAI.

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

    National Foreword
    European foreword
    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
    Bibliography
    Annex ZA (informative) - Relationship between this European
             Standard and the Essential Requirements of EU Directive
             93/42/EEC on Medical devices

    Abstract - (Show below) - (Hide below)

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

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

    Document Type Standard
    Publisher National Standards Authority of Ireland
    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
    EN ISO 23908:2013 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 23908:2011)
    ISO 10993-4:2017 Biological evaluation of medical devices — Part 4: Selection of tests for interactions with blood
    EN ISO 10993-5:2009 Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity (ISO 10993-5:2009)
    EN 15986:2011 Symbol for use in the labelling of medical devices - Requirements for labelling of medical devices containing phthalates
    EN ISO 10993-11:2009 Biological evaluation of medical devices - Part 11: Tests for systemic toxicity (ISO 10993-11:2006)
    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 3826-3:2006 Plastics collapsible containers for human blood and blood components — Part 3: Blood bag systems with integrated features
    EN ISO 10993-10:2013 Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization (ISO 10993-10:2010)
    EN ISO 10993-4:2017 Biological evaluation of medical devices - Part 4: Selection of tests for interactions with blood (ISO 10993-4:2017)
    EN 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 3826-2:2008)
    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
    EN ISO 1135-4 : 2015 COR 2016 TRANSFUSION EQUIPMENT FOR MEDICAL USE - PART 4: TRANSFUSION SETS FOR SINGLE USE, GRAVITY FEED (ISO 1135-4:2015)
    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
    EN ISO 15747:2011 Plastic containers for intravenous injections (ISO 15747:2010)
    ISO 10993-1:2009 Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process
    ISO 1135-4:2015 Transfusion equipment for medical use — Part 4: Transfusion sets for single use, gravity feed
    EN ISO 3826-3:2007 Plastics collapsible containers for human blood and blood components - Part 3: Blood bag systems with integrated features (ISO 3826-3:2006)
    EN ISO 10993-12:2012 Biological evaluation of medical devices - Part 12: Sample preparation and reference materials (ISO 10993-12:2012)
    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)
    EN ISO 3826-1:2013 Plastics collapsible containers for human blood and blood components - Part 1: Conventional containers (ISO 3826-1:2013)
    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
    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)
    ISO 15747:2010 Plastic containers for intravenous injections
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