Abstract
The ISO intracutaneous reactivity test is the standard protocol for determining a medical device's potential for causing irritation. The authors present data indicating that the number of animals required per test can be reduced from three rabbits to two.
This is a preview of subscription content, access via your institution
Access options
Subscribe to this journal
We are sorry, but there is no personal subscription option available for your country.
Buy this article
- Purchase on Springer Link
- Instant access to full article PDF
Prices may be subject to local taxes which are calculated during checkout
Similar content being viewed by others
References
US Pharmacopeia 23/National Formulary 18 Part 87 (US Pharmacopeia Office, Rockville, MD, 2000).
Biological Evaluation of Medical Devices, Part 10: Tests for Irritation and Sensitization, ISO 10993-10 (AAMI, Arlington, VA, 1995).
Biological Evaluation of Medical Devices, Part 12: Sample Preparation and Reference Materials, ISO 10993-12 (AAMI, Arlington VA, 1996).
Draize, J.H. in Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics 46–59 (Association of Food and Drug Officials of the United States, Austin, TX, 1955).
Author information
Authors and Affiliations
Corresponding author
Rights and permissions
About this article
Cite this article
Upman, P., Anderson, J. & Tasse, L. An Analysis of ISO Intracutaneous Reactivity Test Results to Justify a Reduction in Animal Requirements. Lab Anim 32, 26–27 (2003). https://doi.org/10.1038/laban0303-26
Received:
Accepted:
Issue Date:
DOI: https://doi.org/10.1038/laban0303-26
This article is cited by
-
Biocompatibility testing of composite biomaterial designed for a new petal valve construction for pulsatile ventricular assist device
Journal of Materials Science: Materials in Medicine (2021)
