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  • DIN EN ISO 10993-13 E : 2010

    Current The latest, up-to-date edition.

    BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 13: IDENTIFICATION AND QUANTIFICATION OF DEGRADATION PRODUCTS FROM POLYMERIC MEDICAL DEVICES

    Available format(s):  Hardcopy, PDF

    Language(s):  English

    Published date:  01-01-2010

    Publisher:  German Institute for Standardisation (Deutsches Institut für Normung)

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

    National foreword
    Foreword
    Introduction
    1 Scope
    2 Normative references
    3 Terms and definitions
    4 Degradation test methods
    5 Test procedures
    6 Test report
    Annex A (informative) - Analytical methods
    Annex B (informative) - Environmental stress cracking (ESC)
             of polymers
    Annex ZA (informative) - Relationship between this European
             Standard and the Essential Requirements of EU
             Directive 93/42/EEC on Medical Devices
    Annex ZA (informative) - Relationship between this European
             Standard and the Essential Requirements of EU
             Directive 90/385/EEC on Active Implantable Medical
             Devices
    National Annex NA (informative) - Bibliography
    Bibliography

    Abstract - (Show below) - (Hide below)

    Explains two test methods to generate degradation products, an accelerated degradation test as a screening method and a real-time degradation test in a simulated environment.

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

    Document Type Standard
    Publisher German Institute for Standardisation (Deutsches Institut für Normung)
    Status Current

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

    DIN EN ISO 10993-10 E : 2003 BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 10: TESTS FOR IRRITATION AND SKIN SENSITIZATION (ISO 10993-10:2010)
    DIN EN ISO 10993-15 E : 2009 BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 15: IDENTIFICATION AND QUANTIFICATION OF DEGRADATION PRODUCTS FROM METALS AND ALLOYS
    DIN EN ISO 10993-10:2003-02 BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 10: TESTS FOR IRRITATION AND SKIN SENSITIZATION (ISO 10993-10:2010)

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

    ISO 13781:2017 Implants for surgery — Homopolymers, copolymers and blends on poly(lactide) — In vitro degradation testing
    ISO 10993-12:2012 Biological evaluation of medical devices Part 12: Sample preparation and reference materials
    ISO 10993-17:2002 Biological evaluation of medical devices — Part 17: Establishment of allowable limits for leachable substances
    ISO 10993-1:2009 Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process
    DIN EN ISO 10993-12 E : 2012 BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 12: SAMPLE PREPARATION AND REFERENCE MATERIALS (ISO 10993-12:2012)
    ISO 10993-9:2009 Biological evaluation of medical devices Part 9: Framework for identification and quantification of potential degradation products
    ISO 3696:1987 Water for analytical laboratory use — Specification and test methods
    DIN EN ISO 10993-17 E : 2009 BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 17: ESTABLISHMENT OF ALLOWABLE LIMITS FOR LEACHABLE SUBSTANCES
    ISO 14971:2007 Medical devices Application of risk management to medical devices
    DIN ISO 3696:1991-06 WATER FOR ANALYTICAL LABORATORY USE - SPECIFICATION AND TEST METHODS
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