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.
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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).
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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
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DOI: https://doi.org/10.1038/laban0303-26
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