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Withdrawn
A Withdrawn Standard is one, which is removed from sale, and its unique number can no longer be used. The Standard can be withdrawn and not replaced, or it can be withdrawn and replaced by a Standard with a different number.
A Withdrawn Standard is one, which is removed from sale, and its unique number can no longer be used. The Standard can be withdrawn and not replaced, or it can be withdrawn and replaced by a Standard with a different number.
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
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
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