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  • UNE-EN ISO 10993-3:2015

    Current The latest, up-to-date edition.

    Biological evaluation of medical devices - Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity (ISO 10993-3:2014)

    Available format(s):  Hardcopy, PDF

    Language(s):  Spanish, Castilian, English

    Published date:  06-05-2015

    Publisher:  Asociacion Espanola de Normalizacion

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

    Foreword
    Introduction
    1 Scope
    2 Normative references
    3 Terms and definitions
    4 Genotoxicity tests
      4.1 General
      4.2 Test strategy
      4.3 Sample preparation
      4.4 Test methods
          4.4.1 In vitro genotoxicity tests
          4.4.2 In vivo genotoxicity tests
    5 Carcinogenicity tests
      5.1 General
      5.2 Test strategy
      5.3 Sample preparation
      5.4 Test methods
    6 Reproductive and developmental toxicity tests
      6.1 General
      6.2 Test strategy
      6.3 Sample preparation
      6.4 Test methods
    7 Test report
    Annex A (informative) Cell transformation test system
    Annex B (informative) Rationale of test systems
    Annex C (informative) Role of implantation
            carcinogenicity studies
    Bibliography

    Abstract - (Show below) - (Hide below)

    Gives strategies for hazard identification and tests on medical devices for the following biological aspects: genotoxicity, carcinogenicity, and reproductive and developmental toxicity. Applicable for evaluation of a medical device whose potential for genotoxicity, carcinogenicity or reproductive toxicity has been identified. Also provides guidance on selection of tests.

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

    Committee CTN 111
    Development Note Supersedes UNE EN 30993-3. (04/2004)
    Document Type Standard
    Publisher Asociacion Espanola de Normalizacion
    Status Current
    Supersedes

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

    ISO/TR 10993-33:2015 Biological evaluation of medical devices Part 33: Guidance on tests to evaluate genotoxicity Supplement to ISO 10993-3
    ISO 10993-2:2006 Biological evaluation of medical devices — Part 2: Animal welfare requirements
    ISO 10993-18:2005 Biological evaluation of medical devices Part 18: Chemical characterization of materials
    ISO 10993-12:2012 Biological evaluation of medical devices Part 12: Sample preparation and reference materials
    CFR 40(PTS700-789) : JUL 2016 PROTECTION OF ENVIRONMENT - ENVIRONMENTAL PROTECTION AGENCY
    ISO 10993-1:2009 Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process
    ASTM C 1439 : 2013 : REDLINE Standard Test Methods for Evaluating Latex and Powder Polymer Modifiers for use in Hydraulic Cement Concrete and Mortar
    ISO 10993-6:2016 Biological evaluation of medical devices Part 6: Tests for local effects after implantation
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