ANSI/AAMI BE78-2002/(R)2008 – Biological Evaluation of Medical Devices – Part 10

This standard details the tests for irritation and delayed-type hypersensitivity in the biological evaluation of medical devices. It outlines the objectives and uses of AAMI standards and recommended practices, emphasizing the importance of safe and effective application of current technologies and the encouragement of new technologies. The document provides guidance for manufacturers on information to be provided with medical devices, basic safety and performance criteria, and measurement techniques. It also addresses the interpretation of standards and recommended practices, emphasizing the need for professional judgment and consideration of specific needs and resources. This standard was approved on October 1, 2002 by the Association for the Advancement of Medical Instrumentation and reaffirmed on December 3, 2008 by American National Standards Institute, Inc. Abstract: This standard describes the procedure for the assessment of medical devices and their constituent materials with regard to their potential to produce irritation and delayed-type hypersensitivity. Keywords: biological evaluation, hypersensitivity, irritation, medical devices.