Abstract: With the rapid development of material science and immunology, more and more biomaterials are being used in the field of regenerative medicine. The inflammatory and foreign body reactions caused by materials implanted in tissues are obstacles to tissue repair and regeneration, and are also important elements in the biocompatibility evaluation of products. The intensity and duration of the inflammatory response directly affects the histocompatibility and effectiveness of biomaterials. Macrophages are the key immune cells that dominate the inflammatory response and fibrosis, and the number and behaviour of macrophages can reflect whether the material has good biocompatibility. At present, many researchers aim to modulate and induce macrophages in biomaterials, and similarly, biomaterials compatibility evaluation should also focus on macrophages to optimize and improve existing biological evaluation methods and enhance biocompatibility evaluation. In this paper, the progress of biomaterials compatibility evaluation and the interaction between biomaterials and macrophages were reviewed, focusing on the "double-edged sword" role of macrophages in tissue repair and foreign body reaction, aiming to provide researchers in the biomaterials evaluation industry with optimized evaluation methods, innovative ideas and theoretical basis to advance the development of the medical device industry.

Key words: Biomaterial, 　Evaluation of tissue compatibility, 　Macrophage, 　Inflammatory reaction, 　Foreign body reaction