AAMI TIR10993 20 2006 R2021
$99.23
AAMI/ISO TIR10993-20:2006 (R2021) – Biological Evaluation Of Medical Devices – Part 20: Principles And Methods For Immunotoxicology Testing Of Medical Devices
| Published By | Publication Date | Number of Pages |
| AAMI | 2006 |
This standard covers current state of knowledge in the area of immunotoxicology, including information on methods of assessment and their predictive value; to identify what the problems are and how they have been dealt with in the past; and offers advice on how the problems should be addressed in future standards.
PDF Catalog
| PDF Pages | PDF Title |
|---|---|
| 1 | AAMI/ISO TIR10993-20:2006/(R)2021, Biological evaluation of medical devices – Part 20: Principles and methods for immunotoxicology testing of medical devices |
| 2 | Title page |
| 3 | Copyright information |
| 4 | AAMI technical information report ANSI technical report |
| 5 | Contents |
| 6 | Glossary of equivalent standards |
| 8 | Committee representation |
| 10 | Background of AAMI adoption of ISO/TS 10993-20:2006 |
| 11 | Foreword |
| 13 | Introduction |
| 14 | 1 Scope 2 Normative references 3 Terms and definitions |
| 15 | 4 Risk assessment and risk management |
| 16 | 5 Identification of hazards |
| 18 | 6 Methods of assessment of immunotoxicity 6.1 General |
| 19 | 6.2 Inflammation 6.3 Immunosuppression |
| 21 | 6.4 Immunostimulation 6.5 Hypersensitivity 6.6 Auto-immunity 7 Extrapolation of data provided by pre-clinical assays |
| 23 | Annex A (informative) Current state of knowledge A.1 Immunology |
| 24 | A.2 Immunotoxicology |
| 25 | A.3 Human health consequences of changes in the immune system |
| 27 | Annex B (informative) Clinical experience with medical devices |
| 29 | Annex C (informative) Flow chart for immunotoxicity testing |
| 30 | Bibliography |
