AAMI 10993 13 2010 RA 2014
$65.83
ANSI/AAMI/ISO 10993-13-2010/(R)2014 – Biological evaluation of medical devices-Part 13: Identification and quantification of degradation products from polymeric devices
| Published By | Publication Date | Number of Pages |
| AAMI | 201 | 28 |
Describes general requirements for the design of tests in a simulated environment for identifying and quantifying degradation products from finished polymeric medical devices ready for clinical use.
PDF Catalog
| PDF Pages | PDF Title |
|---|---|
| 1 | ANSI/AAMI/ISO 10993-13:2010/(R)2014, Biological evaluation of medical devices — Part 13: Identification and quantification of degradation products from polymeric medical devices |
| 2 | Objectives and uses of AAMI standards and recommended practices |
| 3 | Title page |
| 4 | AAMI Standard Copyright information |
| 5 | Contents |
| 6 | Glossary of equivalent standards |
| 8 | Committee representation |
| 9 | Background of ANSI/AAMI adoption of ISO 10993-13 |
| 10 | Foreword |
| 12 | Introduction |
| 13 | 1 Scope 2 Normative references |
| 14 | 3 Terms and definitions 4 Degradation test methods 4.1 General procedures 4.1.1 Test design |
| 15 | 4.1.2 Sample preparation 4.1.3 Initial material characterization 4.1.4 Test solutions and apparatus 4.1.4.1 Test solutions 4.1.4.1.1 General 4.1.4.1.2 Test solutions for hydrolytic degradation |
| 16 | 4.1.4.1.3 Test solutions for oxidative degradation 4.1.4.2 Container 4.1.4.3 Balance 4.1.4.4 Drying apparatus 4.1.4.5 Vacuum source 4.1.4.6 Separation apparatus |
| 17 | 4.1.5 Number of test samples 4.1.6 Shape and size of test samples 4.1.7 Mass/volume ratio 4.1.8 Sample pre-treatment 4.1.9 pH range |
| 18 | 4.1.10 Determination of the mass balance 4.1.11 Final material characterization 4.2 Accelerated degradation test 4.2.1 Temperature 4.2.2 Test periods 4.3 Real-time degradation test in a simulated environment 4.3.1 Temperature |
| 19 | 4.3.2 Test period 5 Test procedures 5.1 General 5.2 Initial material characterization 5.3 Accelerated degradation test 5.3.1 Measurement of initial mass 5.3.2 Separation of sample, debris and solution 5.3.2.1 Separation by filtering 5.3.2.2 Separation by centrifuging |
| 20 | 5.3.3 Analysis 5.3.3.1 Determination of mass balance 5.3.3.2 Final material characterization (sample and debris) 5.3.4 Evaluation 5.3.4.1 General 5.3.4.2 Case 1 (No/No) 5.3.4.3 Case 2 (No/Yes) 5.3.4.4 Case 3 (Yes/No) |
| 21 | 5.3.4.5 Case 4 (Yes/Yes) |
| 22 | 5.4 Real-time degradation test in a simulated environment 5.4.1 Measurement of initial mass 5.4.2 Separation of sample, debris and solution 5.4.2.1 Separation by filtering 5.4.2.2 Separation by centrifuging 5.4.3 Analysis 5.4.3.1 Determination of mass balance 5.4.3.2 Final material characterization (sample and debris) 5.4.4 Evaluation 5.4.4.1 General 5.4.4.2 Case 1 (No/No) |
| 23 | 5.4.4.3 Case 2 (No/Yes) 5.4.4.4 Case 3 (Yes/No) 5.4.4.5 Case 4 (Yes/Yes) 6 Test report |
| 25 | Annex A Analytical methods |
| 26 | Annex B Environmental stress cracking (ESC) of polymers B.1 General B.2 Types of polymer impacted B.3 Models for testing |
| 27 | B.4 Evaluation of results B.4.1 Biological impact B.4.2 Device performance B.5 Reporting of results |
| 28 | Bibliography |
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