This document provides guidelines for the biological evaluation of medical devices, specifically focusing on the testing methods for irritation and delayed-type hypersensitivity reactions. It outlines the general requirements for conducting these tests, including the selection of appropriate test methods, the preparation of test items, and the interpretation of results. The standard is applicable to a wide range of medical devices intended for contact with human tissues or skin. It addresses the necessary steps for the identification and assessment of potential adverse biological reactions caused by the device. The document also includes considerations for the use of alternative methods where applicable, ensuring that the testing procedures are both scientifically valid and ethically sound. This standard is part of a series that collectively supports the comprehensive biological evaluation of medical devices throughout their lifecycle.
*** Please note: This description may not be accurate, please refer to the official documentation.