Customer Service:
Mon - Fri: 8:30 am - 6 pm EST

 Most recent

ANSI/AAMI/ISO TIR10993-20:2006

Biological evaluation of medical devices - Part 20: Principles and methods for immunotoxicology testing of medical devices

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.

Content Provider
Association for the Advancement of Medical Instrumentation [aami]

Others Also Bought

Biological evaluation of medical devices - Part 19: Physicochemical, morphological, and topographical characterization ...
Biological evaluation of medical devices - Part 2: Animal welfare requirements
Biological evaluation of medical devices - Part 16: Toxicokinetic study design for degradation products and le ...
Document History
We have no document history for this standard.
Included in Packages
This standard is not included in any packages.
Amendments & Corrections
We have no amendments or corrections for this standard.

As the voice of the U.S. standards and conformity assessment system, the American National Standards Institute (ANSI) empowers its members and constituents to strengthen the U.S. marketplace position in the global economy while helping to assure the safety and health of consumers and the protection of the environment.