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    I.S. EN ISO 10993-13:2010

    Current The latest, up-to-date edition.

    BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 13: IDENTIFICATION AND QUANTIFICATION OF DEGRADATION PRODUCTS FROM POLYMERIC MEDICAL DEVICES (ISO 10993-13:2010)

    Available format(s):  Hardcopy, PDF

    Language(s):  English

    Published date:  01-01-2010

    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 Degradation test methods
    5 Test procedures
    6 Test report
    Annex A (informative) - Analytical methods
    Annex B (informative) - Environmental stress cracking
            (ESC) of polymers
    Bibliography
    Annex ZA (informative) - Relationship between this European
             Standard and the Essential Requirements of EU Directive
             93/42/EEC on Medical devices
    Annex ZB (informative) - Relationship between this European
             Standard and the Essential Requirements of EU Directive
             90/385/EEC on Active Implantable Medical Devices

    Abstract - (Show below) - (Hide below)

    Specifies general requirements for the design of tests in a simulated environment for identifying and quantifying degradation products from finished polymeric medical devices ready for clinical use.

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

    Document Type Standard
    Publisher National Standards Authority of Ireland
    Status Current
    Supersedes

    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
    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
    ISO 14971:2007 Medical devices Application of risk management to medical devices
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