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  • BS EN 30993-5:1994

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    Superseded A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.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 Tests for cytotoxicity, in vitro methods

    Available format(s):  Hardcopy, PDF

    Superseded date:  15-09-1999

    Language(s):  English

    Published date:  15-07-1994

    Publisher:  British Standards Institution

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

    Cooperating organizations
    National foreword
    Foreword
    1. Scope
    2. Normative reference
    3. Definitions
    4. Sample preparation
    4.1 General
    4.2 Preparation of liquid extracts of material
    4.3 Preparation of material for direct contact tests
    5. Cell lines
    6. Culture medium
    7. Preparation of cell-stock culture
    8. Test procedures
    8.1 Number of replicates
    8.2 Test on extracts
    8.3 Test by direct contact
    8.4 Test by indirect contact
    8.5 Determination of cytotoxicity
    9. Test report
    10. Assessment of results
    Annex
    A. Bibliography
    National annex NA (informative) Committees responsible
    National annex NB (informative) Cross-reference

    Abstract - (Show below) - (Hide below)

    Describes test methods to assess the in vitro cytotoxicity of medical devices. Coverage includes definitions, cell lines, culture medium, and determination of cytotoxicity.

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    Committee CH/194
    Development Note Supersedes BS 5736: Part 10: 1988 BS Draft 91/55176 DC
    Document Type Standard
    Publisher British Standards Institution
    Status Superseded
    Superseded By
    Supersedes

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

    ISO 10993-1:2009 Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process
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