ANSI/AAMI/ISO TIR10993-20:2006
Withdrawn
A Withdrawn Standard is one, which is removed from sale, and its unique number can no longer be used. The Standard can be withdrawn and not replaced, or it can be withdrawn and replaced by a Standard with a different number.
View Superseded by
BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 20: PRINCIPLES AND METHODS FOR IMMUNOTOXICOLOGY TESTING OF MEDICAL DEVICES
Hardcopy , PDF
09-04-2024
English
05-09-2005
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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 |
Withdrawn
|
| 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 |
| 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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