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eLibrary > ANSI/AAMI/ISO 10993-15:2019 Biological evaluation of medical devices-Part 15: Identification and quantification of degradation products from metals and alloys >

ANSI/AAMI/ISO 10993-15:2019 Biological evaluation of medical devices-Part 15: Identification and quantification of degradation products from metals and alloys, 2019

ANSI/AAMI/ISO 10993-15:2019; Biological evaluation of medical devices—Part 15: Identification and quantification of degradation products from metals and alloys
Title page
AAMI Standard
Copyright information
Contents Page
Committee representation
Background of ANSI/AAMI adoption of ISO 10993-15:2019
Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Degradation test methods [Go to Page]
4.1 General
4.2 Prerequisites
5 Reagent and sample preparation [Go to Page]
5.1 Sample documentation
5.2 Test solution (electrolyte)
5.3 Preparation of test samples [Go to Page]
5.3.1 Test samples
5.3.2 Sampling
5.3.3 Sample shape
5.3.4 Sample surface condition
6 Electrochemical tests [Go to Page]
6.1 Apparatus
6.2 Sample preparation
6.3 Test conditions
6.4 Potentiodynamic measurements [Go to Page]
Figure 1Plot of current density versus potential, showing the start of corrosion current at Ea and breakdown potential, Ep
Figure 2—Log current density versus potential plot showing the breakdown potential, Ep, at the inflection point of the curve
6.5 Potentiostatic measurements
7 Immersion test [Go to Page]
7.1 Apparatus
7.2 Sample preparation
7.3 Immersion test procedure
8 Analysis
9 Test report
Annex A (informative) Electrolytes for the electrochemical tests [Go to Page]
A.1 General
A.2 Isotonic aqueous solution of 0,9 % sodium chloride
A.3 Artificial saliva[2]
A.4 Artificial plasma[2]
A.5 Phosphate Buffered Saline (PBS) (sterile filtered tissue culture grade)
Annex B (informative) Schematic diagram of the electrochemical measuring circuit [Go to Page]
Figure B.1—Schematic diagram of the electrochemical measuring circuit
Annex C (informative) Schematic drawing of an electrolytic cell [Go to Page]
Figure C.1—Schematic drawing of an electrolytic cell
Bibliography [Go to Page]

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