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  • 15/30290736 DC : 0

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    Superseded A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
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    BS EN ISO 10993-4 - BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 4: SELECTION OF TESTS FOR INTERACTIONS WITH BLOOD

    Available format(s):  Hardcopy, PDF

    Superseded date:  31-05-2017

    Language(s):  English

    Published date: 

    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 Abbreviated terms
    5 Types of devices in contact with blood
      (as categorized in ISO 10993-1:2009)
    6 Characterization of blood interactions
    Annex A (informative) - Preclinical evaluation of
            cardiovascular devices and prostheses
    Annex B (informative) - Recommended laboratory
            tests - principles, scientific basis and Interpretation
    Annex C (informative) - Thrombosis - Methods for
            in vivo testing
    Annex D (informative) - Haematology/haemolysis
            Methods for testing - Evaluation of haemolytic
            properties of medical devices and medical device
            materials
    Annex E (informative) - Complement - Methods for testing
    Annex F (informative) - Less common laboratory tests
    Annex G (informative) - Tests which are not recommended
    Bibliography

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

    Comment Closes On
    Committee CH/194
    Document Type Draft
    Publisher British Standards Institution
    Status Superseded
    Superseded By

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

    ISO/IEC 17025:2005 General requirements for the competence of testing and calibration laboratories
    ASTM F 756 : 2017 : REDLINE Standard Practice for Assessment of Hemolytic Properties of Materials
    CFR 29(PTS1900-1910) : 0 LABOR - OCCUPATIONAL SAFETY AND HEALTH ADMINISTRATION, DEPARTMENT OF LABOR
    ISO 5840:2005 Cardiovascular implants Cardiac valve prostheses
    ANSI/AAMI/ISO 15675:2016 CARDIOVASCULAR IMPLANTS AND ARTIFICIAL ORGANS - CARDIOPULMONARY BYPASS SYSTEMS - ARTERIAL BLOOD LINE FILTERS
    ISO 7198:2016 Cardiovascular implants and extracorporeal systems — Vascular prostheses — Tubular vascular grafts and vascular patches
    ISO 8637:2010 Cardiovascular implants and extracorporeal systems Haemodialysers, haemodiafilters, haemofilters and haemoconcentrators
    ISO 14708-5:2010 Implants for surgery Active implantable medical devices Part 5: Circulatory support devices
    ISO 3826-3:2006 Plastics collapsible containers for human blood and blood components — Part 3: Blood bag systems with integrated features
    ISO 10993-2:2006 Biological evaluation of medical devices — Part 2: Animal welfare requirements
    EN ISO 10993-4:2017 Biological evaluation of medical devices - Part 4: Selection of tests for interactions with blood (ISO 10993-4:2017)
    ISO 15675:2016 Cardiovascular implants and artificial organs — Cardiopulmonary bypass systems — Arterial blood line filters
    ISO 14708-2:2012 Implants for surgery Active implantable medical devices Part 2: Cardiac pacemakers
    AAMI RD16 : 2007 CARDIOVASCULAR IMPLANTS AND ARTIFICIAL ORGANS - HEMODIALYZERS, HEMODIAFILTERS, HEMOFILTERS AND HEMOCONCENTRATORS
    ANSI/AAMI/ISO 7198:2016 CARDIOVASCULAR IMPLANTS AND EXTRACORPOREAL SYSTEMS - VASCULAR PROSTHESES - TUBULAR VASCULAR GRAFTS AND VASCULAR PATCHES
    ISO 7199:2016 Cardiovascular implants and artificial organs Blood-gas exchangers (oxygenators)
    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 15674:2016 Cardiovascular implants and artificial organs — Hard-shell cardiotomy/venous reservoir systems (with/without filter) and soft venous reservoir bags
    ISO 10993-1:2009 Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process
    CFR 21(PTS1-99) : 0 FOOD AND DRUGS - FOOD AND DRUG ADMINISTRATION, CHAPTER 1 DEPARTMENT OF HEALTH AND HUMAN SERVICES - PARTS 1-99
    SAC GB/T 16175 : 1996 BIOLOGICAL EVALUATION TEST METHODS FOR MEDICAL ORGANIC SILICON MATERIALS
    BS EN 30993-4:1994 Biological evaluation of medical devices Selection of tests for interactions with blood
    ISO 12891-1:2015 Retrieval and analysis of surgical implants Part 1: Retrieval and handling
    ASTM F 2888 : 2013 Standard Test Method for Platelet Leukocyte Count—An In-Vitro Measure for Hemocompatibility Assessment of Cardiovascular Materials
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