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    I.S. EN ISO 10993-5:2009

    Current The latest, up-to-date edition.

    BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 5: TESTS FOR IN VITRO CYTOTOXICITY (ISO 10993-5:2009)

    Available format(s):  Hardcopy, PDF

    Language(s):  English

    Published date:  01-01-2009

    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)

    Foreword
    Introduction
    1 Scope
    2 Normative references
    3 Terms and definitions
    4 Sample and control preparation
       4.1 General
       4.2 Preparation of liquid extracts of material
       4.3 Preparation of material for direct-contact tests
       4.4 Preparation of controls
    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 (informative) - Neutral red uptake (NRU)
            cytotoxicity test
    Annex B (informative) - Colony formation cytotoxicity
            test
    Annex C (informative) - MTT cytotoxicity test
    Annex D (informative) - XTT cytotoxicity test
    Bibliography
    Annex ZA (informative) - Relationship between this International
             Standard and the Essential Requirements of EU
             Directive 93/42/EEC
    Annex ZB (informative) - Relationship between this International
             Standard and the Essential Requirements of EU
             Directive 90/385/EEC

    Abstract - (Show below) - (Hide below)

    Specifies test methods to assess the in vitro cytotoxicity of medical devices.

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

    Development Note Supersedes I.S. EN 30993-5. (05/2007)
    Document Type Standard
    Publisher National Standards Authority of Ireland
    Status Current
    Supersedes

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

    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
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