The main content of the Guidelines for the Implementation of Biological Evaluation Criteria for Medical Devices is that in the past 20 years, with the development of modern science and technology, medical devices have been developing rapidly worldwide, and a large number of new types of medical devices have been widely used in clinical practice. While benefiting human beings, the improper selection of certain product materials or the influence of various processing residues have brought about a series of biological hazards to human beings that cannot be ignored. In order to ensure the safety and effectiveness of medical devices in clinical use, preclinical biological evaluation of medical devices and the global unification of evaluation methods has attracted great attention from governments and biological evaluation experts around the world, and for this reason, the International Organization for Standardization (ISO) formally established the ISO/TCl94 Technical Committee on Biological Evaluation of Medical Devices in 1989, and successively formulated and promulgated a series of ISO10993 standards. The ISO10993 series of standards have been formulated and promulgated successively. These standards have been gradually recognized and adopted by countries around the world.