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Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
Hardcopy , PDF
25-05-2023
English
01-01-2009
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.
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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