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AAMI 10993 15 2019

AAMI 10993 15 2019

$77.96

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

Published By Publication Date Number of Pages
AAMI 2019 24
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This standard provides 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.

PDF Catalog

PDF Pages PDF Title
1 ANSI/AAMI/ISO 10993-15:2019; Biological evaluation of medical devices—Part 15:
Identification and quantification of degradation products from metals and alloys
3 Title page
4 AAMI Standard
Copyright information
5 Contents Page
6 Committee representation
8 Background of ANSI/AAMI adoption of ISO 10993-15:2019
9 Foreword
10 Introduction
11 1 Scope
2 Normative references
12 3 Terms and definitions
13 4 Degradation test methods
4.1 General
4.2 Prerequisites
14 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
15 5.3.4 Sample surface condition
6 Electrochemical tests
6.1 Apparatus
6.2 Sample preparation
6.3 Test conditions
6.4 Potentiodynamic measurements
16 Figure 1Plot of current density versus potential, showing the start of corrosion current at Ea and breakdown potential, Ep
17 Figure 2—Log current density versus potential plot showing the breakdown potential, Ep, at the inflection point of the curve
6.5 Potentiostatic measurements
18 7 Immersion test
7.1 Apparatus
7.2 Sample preparation
7.3 Immersion test procedure
19 8 Analysis
9 Test report
21 Annex A (informative) Electrolytes for the electrochemical tests
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)
22 Annex B (informative) Schematic diagram of the electrochemical measuring circuit
Figure B.1—Schematic diagram of the electrochemical measuring circuit
23 Annex C (informative) Schematic drawing of an electrolytic cell
Figure C.1—Schematic drawing of an electrolytic cell
24 Bibliography

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AAMI 10993 15 2019
$77.96