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  • BS EN ISO 3826-1:2013

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    Superseded A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
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    Plastics collapsible containers for human blood and blood components Conventional containers

    Available format(s):  Hardcopy, PDF

    Superseded date:  11-04-2023

    Language(s):  English

    Published date:  30-06-2013

    Publisher:  British Standards Institution

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

    Foreword
    Introduction
    1 Scope
    2 Normative references
    3 Terms and definitions
    4 Dimensions and designation
    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)

    Describes requirements, including performance requirements, for plastics collapsible, non-vented, sterile containers complete with collecting tube outlet port(s), integral needle, and with optional transfer tube(s), for the collection, storage, processing, transport, separation, and administration of blood and blood components.

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

    Committee CH/212
    Development Note Supersedes 99/563577 DC. (12/2003) Together with BS EN ISO 1135-4 and BS EN ISO 3826-3, supersedes BS 2463-1(1990) and BS 2463-2(1989). (04/2007)
    Document Type Standard
    Publisher British Standards Institution
    Status Superseded
    Superseded By
    Supersedes

    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
    EN 15986:2011 Symbol for use in the labelling of medical devices - Requirements for labelling of medical devices containing phthalates
    ISO 9626:2016 Stainless steel needle tubing for the manufacture of medical devices — Requirements and test methods
    ISO 3826-3:2006 Plastics collapsible containers for human blood and blood components — Part 3: Blood bag systems with integrated features
    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 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
    ISO 3696:1987 Water for analytical laboratory use — Specification and test methods
    ISO 15223-1:2016 Medical devices Symbols to be used with medical device labels, labelling and information to be supplied Part 1: General requirements
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