Biological evaluation of medical devices - Part 4: Selection of tests for interactions with blood (ISO 10993-4:2002+Amd.1:2006) (includes Amendment A1:2006)

This standard provides guidance on the selection of tests for evaluating the biological safety of medical devices that interact with blood. It outlines the principles and criteria for determining the appropriate tests based on the potential risks associated with blood contact. The document includes information on relevant test methods, their application, and the interpretation of results. It also addresses the evaluation of hemocompatibility, including effects on blood cells, coagulation, and platelet function. The standard is structured to assist manufacturers and regulatory bodies in ensuring that medical devices meet safety requirements when in contact with blood. It incorporates amendments and corrections to ensure consistency and accuracy in the testing procedures.