EN ISO 10993-15:2009
Withdrawn
A Withdrawn Standard is one, which is removed from sale, and its unique number can no longer be used. The Standard can be withdrawn and not replaced, or it can be withdrawn and replaced by a Standard with a different number.
Biological evaluation of medical devices - Part 15: Identification and quantification of degradation products from metals and alloys (ISO 10993-15:2000)
21-03-2010
10-06-2009
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
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