AAMI 10993 15 2000 RA 2011
$75.64
ANSI/AAMI/ISO 10993-15:2000/(R)2011 – 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 | 2000 | 22 |
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 10993-15:200/(R)2011, Biological evaluation of medical devices—Part 15: Identification and quantification of degradation products from metals and a |
| 2 | The Objectives and Uses of AAMI Standards and Recommended Practices |
| 3 | ANSI/AAMI/ISO 10993-15:2000 Approved 16 October 2000 |
| 4 | Copyright page |
| 5 | Contents |
| 7 | Glossary of equivalent standards |
| 9 | Committee representation |
| 10 | Background of AAMI adoption of ISO 10993-15:2000 |
| 11 | Foreword |
| 12 | Introduction |
| 13 | 1 Scope 2 Normative references |
| 14 | 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) |
| 15 | 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 |
| 16 | 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 |
| 18 | 8 Analysis 9 Test report |
| 19 | Annex A, Schematic diagram of the electrochemical measuring circuit |
| 20 | Annex B, Schematic drawing of an electrolytic cell |
| 21 | Annex C, Electrolytes for the electrochemical tests |
| 22 | Bibliography |
