AAMI ISO 10993-15 : 2000 : R2011

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

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.