EN ISO 10993-15:2009

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

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.