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 principles and 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 and materials intended for contact with human tissues or skin. It addresses the assessment of potential adverse reactions that may occur following exposure to medical devices, ensuring that the testing procedures are scientifically valid and reproducible. The document also includes information on the use of alternative methods and the consideration of ethical aspects in testing. It is intended to be used in conjunction with other relevant standards in the series for comprehensive biological evaluation of medical devices.
*** Please note: This description may not be accurate, please refer to the official documentation.