ANSI/AAMI/ISO TIR10993-20:2006
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
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BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 20: PRINCIPLES AND METHODS FOR IMMUNOTOXICOLOGY TESTING OF MEDICAL DEVICES
Hardcopy , PDF
English
05-09-2005
09-04-2024
Glossary of equivalent standards
Committee representation
Background of AAMI adoption of ISO/TS 10993-20
Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Risk assessment and risk management
5 Identification of hazards
6 Methods of assessment of immunotoxicity
6.1 General
6.2 Inflammation
6.3 Immunosuppression
6.4 Immunostimulation
6.5 Hypersensitivity
6.6 Auto-immunity
7 Extrapolation of data provided by pre-clinical assays
Annex A (informative) Current state of knowledge
Annex B (informative) Clinical experience with medical
devices
Annex C (informative) Flow chart for immunotoxicity testing
Bibliography
Gives an overview of immunotoxicology with particular reference to the potential immunotoxicity of medical devices.
| Committee |
WG 07
|
| DocumentType |
Standard
|
| ISBN |
1570202680
|
| Pages |
33
|
| PublisherName |
Association for the Advancement of Medical Instrumentation
|
| Status |
Superseded
|
| SupersededBy |
| Standards | Relationship |
| ISO/TS 10993-20:2006 | Identical |
| AAMI TIR17 : 2008 | COMPATIBILITY OF MATERIALS SUBJECT TO STERILIZATION |
| AAMI TIR17 : 2017 | COMPATIBILITY OF MATERIALS SUBJECT TO STERILIZATION |
| AAMI TIR17:2017(R2023) | Compatibility of materials subject to sterilization |
| ISO 10993-2:2006 | Biological evaluation of medical devices — Part 2: Animal welfare requirements |
| ISO 10993-10:2010 | Biological evaluation of medical devices — Part 10: Tests for irritation and skin sensitization |
| ISO 10993-11:2017 | Biological evaluation of medical devices — Part 11: Tests for systemic toxicity |
| ISO 10993-1:2009 | Biological evaluation of medical devices — Part 1: Evaluation and testing within a risk management process |
| ISO 14971:2007 | Medical devices — Application of risk management to medical devices |
| ISO 10993-6:2016 | Biological evaluation of medical devices — Part 6: Tests for local effects after implantation |
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