• AAMI ISO 10993-15 : 2000

    Superseded A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.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

    Available format(s):  Hardcopy, PDF

    Superseded date:  01-09-2021

    Language(s):  English

    Published date:  01-01-2011

    Publisher:  Association for the Advancement of Medical Instrumentation

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

    Glossary of equivalent standards
    Committee representation
    Background of AAMI adoption of ISO 10993-15:2000
    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
          5.3.1 Test samples
          5.3.2 Sampling
          5.3.3 Sample shape
          5.3.4 Sample surface condition
    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
    Annexes
    A - Schematic diagram of the electrochemical measuring
        circuit
    B - Schematic drawing of an electrolytic cell
    C - Electrolytes for the electrochemical tests
    Bibliography

    Abstract - (Show below) - (Hide below)

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

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

    Committee WG 02
    Document Type Standard
    Product Note Reconfirmed 2000
    Publisher Association for the Advancement of Medical Instrumentation
    Status Superseded
    Superseded By

    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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