• I.S. EN ISO 10993-15:2009

    Superseded A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

    BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 15: IDENTIFICATION AND QUANTIFICATION OF DEGRADATION PRODUCTS FROM METALS AND ALLOYS (ISO 10993-15:2000)

    Available format(s):  Hardcopy, PDF

    Superseded date:  25-05-2023

    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 Degradation test methods
      4.1 General
      4.2 Prerequisites
    5 Reagent and sample preparation
      5.1 Sample documentation
      5.2 Test solution (electrolyte)
      5.3 Preparation of test samples
    6 Electrochemical tests
      6.1 Apparatus
      6.2 Sample preparation
      6.3 Test conditions
      6.4 Potentiodynamic measurements
      6.5 Potentiostatic measurements
    7 Immersion test
      7.1 Apparatus
      7.2 Sample preparation
      7.3 Immersion test procedure
    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

    Abstract - (Show below) - (Hide below)

    Gives 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 National Standards Authority of Ireland
    Status Superseded
    Superseded By
    Supersedes

    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
    ISO 10271:2011 Dentistry Corrosion test methods for metallic materials
    ISO 10993-14:2001 Biological evaluation of medical devices — Part 14: Identification and quantification of degradation products from ceramics
    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
    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
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