Biological evaluation of medical devices - Part 6: Tests for local effects after implantation (ISO 10993-6:2007)

This standard outlines procedures for evaluating the biological effects of medical devices following implantation. It focuses on local reactions that may occur at the site of implantation. The document provides guidance on testing methods and criteria for assessing the safety of medical devices in terms of their impact on the surrounding tissue. It includes information on the selection of test samples, the preparation of test specimens, and the evaluation of responses such as inflammation or fibrosis. The standard also addresses the interpretation of results and the documentation required for compliance. It is intended for use by manufacturers, regulatory bodies, and researchers involved in the biological evaluation of medical devices.