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  • BS EN 30993-4:1994

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    Superseded A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
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    Biological evaluation of medical devices Selection of tests for interactions with blood

    Available format(s):  Hardcopy, PDF

    Superseded date:  14-11-2002

    Language(s):  English

    Published date:  15-04-1994

    Publisher:  British Standards Institution

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

    Cooperating organizations
    National foreword
    Foreword
    Introduction
    1 Scope
    2 Normative references
    3 Definitions
    4 Abbreviations
    5 Devices contacting blood
    6 Tests
    Annex A (informative) - Evaluation of cardiovascular devices
            and prostheses during in vivo function
    Annex B (informative) - Laboratory tests: principles and
            scientific basis
    Annex C (informative) - Bibliography
    National annex NA (informative) - Committees responsible
    National annex NB (informative) - Cross-reference

    Abstract - (Show below) - (Hide below)

    Provides guidance to agencies, manufacturers, research laboratories and others for evaluating the interactions of medical devices with blood.

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

    Committee CH/194
    Development Note Supersedes BS 5736-11(1990) & 91/55175 DC. (12/2008)
    Document Type Standard
    Publisher British Standards Institution
    Status Superseded
    Superseded By
    Supersedes

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

    15/30290736 DC : 0 BS EN ISO 10993-4 - BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 4: SELECTION OF TESTS FOR INTERACTIONS WITH BLOOD

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

    ASTM F 756 : 2017 : REDLINE Standard Practice for Assessment of Hemolytic Properties of Materials
    ISO 5840:2005 Cardiovascular implants Cardiac valve prostheses
    NFS 90 300 : 1981
    AAMI CVP3 : 1981 CARDIAC VALVE PROSTHESES
    ISO 7199:2016 Cardiovascular implants and artificial organs Blood-gas exchangers (oxygenators)
    BS EN 30993-1:1994 Biological evaluation of medical devices Guidance on selection of tests
    AAMI VP20 : 2ED 94 CARDIOVASCULAR IMPLANTS - VASCULAR GRAFT PROSTHESES
    ISO 10993-12:2012 Biological evaluation of medical devices Part 12: Sample preparation and reference materials
    ISO 5841-3:2013 Implants for surgery — Cardiac pacemakers — Part 3: Low-profile connectors (IS-1) for implantable pacemakers
    ISO 10993-1:2009 Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process
    DIN 58361-4:1980-09 TRANSFUSION, INFUSION, TRANSFUSION CONTAINERS AND ACCESSORIES, PLASTIC CONTAINERS FOR BLOOD, REQUIREMENTS, TESTS, SUPERVISION AND LABELLING
    ISO 5841-1:1989 Cardiac pacemakers Part 1: Implantable pacemakers
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