DD ISO/TS 10993-20:2006

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

Provides an overview of immunotoxicology with particular reference to the potential immunotoxicity of medical devices. It gives guidance on methods for testing for immunotoxicity of various types of medical devices.

This part of ISO10993 presents an overview of immunotoxicology with particular reference to the potential immunotoxicity of medical devices. It gives guidance on methods for testing for immunotoxicity of various types of medical devices.

This part of ISO10993 is based on several publications written by various groups of immunotoxicologists over the last few decades in which the development of immunotoxicology as a separate entity within toxicology took place.

The current state of knowledge with regard to immunotoxicity is described in AnnexA. A summary of clinical experience to date with immunotoxicology associated with medical devices is given in AnnexB.

NOTE See also Bibliographic Reference [11].