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  • DIN EN ISO 10993-15 E : 2009

    Current The latest, up-to-date edition.

    BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 15: IDENTIFICATION AND QUANTIFICATION OF DEGRADATION PRODUCTS FROM METALS AND ALLOYS

    Available format(s):  Hardcopy, PDF

    Language(s):  English

    Published date:  01-01-2009

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

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

    Foreword
    Introduction
    1 Scope
    2 Normative references
    3 Terms and definitions
    4 Degradation test methods
    5 Reagent and sample preparation
    6 Electrochemical tests
    7 Immersion test
    8 Analysis
    9 Test report
    Annex A (informative) - Schematic diagram of the
            electrochemical measuring circuit
    Annex B (informative) - Schematic drawing of an
            electrolytic cell
    Annex C (informative) - Examples of alternative
            electrolytes for the electrochemical tests
    Bibliography
    Annex ZA (informative) - Relationship between this
             European Standard and the Essential Requirements
             of EU Directive 93/42/EEC on Medical Devices
    National Annex NA (informative) - Bibliography

    Abstract - (Show below) - (Hide below)

    Describes guidance on general requirements for the design of tests for identifying and quantifying degradation products from finished metallic medical devices or corresponding material samples finished as ready for clinical use.

    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 10993-10:2003-02 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 10993-16:2017 Biological evaluation of medical devices — Part 16: Toxicokinetic study design for degradation products and leachables
    NFS 91 141 : 1997 BIODEGRADABILITY OF DENTAL METAL ALLOYS - STANDARDIZATION OF ELECTROCHEMICAL TESTS
    ISO 10993-13:2010 Biological evaluation of medical devices — Part 13: Identification and quantification of degradation products from polymeric medical devices
    ISO 3585:1998 Borosilicate glass 3.3 Properties
    DIN EN ISO 10993-16 E : 2010 BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 16: TOXICOKINETIC STUDY DESIGN FOR DEGRADATION PRODUCTS AND LEACHABLES (ISO 10993-16:2017)
    ISO 10271:2011 Dentistry Corrosion test methods for metallic materials
    DIN EN ISO 10993-14 E : 2009 BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 14: IDENTIFICATION AND QUANTIFICATION OF DEGRADATION PRODUCTS FROM CERAMICS
    ISO 10993-14:2001 Biological evaluation of medical devices — Part 14: Identification and quantification of degradation products from ceramics
    DIN EN ISO 8044:2015-12 CORROSION OF METALS AND ALLOYS - BASIC TERMS AND DEFINITIONS (ISO 8044:2015)
    DIN EN ISO 10993-13 E : 2010 BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 13: IDENTIFICATION AND QUANTIFICATION OF DEGRADATION PRODUCTS FROM POLYMERIC MEDICAL DEVICES
    ISO 10993-12:2012 Biological evaluation of medical devices Part 12: Sample preparation and reference materials
    ISO 8044:2015 Corrosion of metals and alloys Basic terms and definitions
    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 ISO 3696:1991-06 WATER FOR ANALYTICAL LABORATORY USE - SPECIFICATION AND TEST METHODS
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