ISO/TS 10993-20:2006
Biological evaluation of medical devices - Part 20: Principles and methods for immunotoxicology testing of medical devices
- Standard No.
- ISO/TS 10993-20:2006
- Release Date
- 2006
- Published By
- International Organization for Standardization (ISO)
- Latest
- ISO/TS 10993-20:2006
- Scope
- This part of ISO 10993 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 ISO 10993 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 Annex A. A summary of clinical experience to date with immunotoxicology associated with medical devices is given in Annex B. NOTE See also Bibliographic Reference [11].
ISO/TS 10993-20:2006 history
- 2006 ISO/TS 10993-20:2006 Biological evaluation of medical devices - Part 20: Principles and methods for immunotoxicology testing of medical devices
