DD ISO/TS 10993-20:2006
Current
The latest, up-to-date edition.
Biological evaluation of medical devices Principles and methods for immunotoxicology testing of medical devices
Hardcopy , PDF
English
29-09-2006
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
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