目的 探讨医美类医疗器械生物学评价的要点，保障其在临床应用中的安全性和有效性，为行业监管及技术审查提供科学依据，助力行业规范发展。方法 系统梳理已上市的医美类医疗器械，结合国内外相关法规及技术标准，进一步探讨医美类医疗器械生物相容性试验中的常见问题和解决方案。结果 医美类医疗器械的生物学评价需重点关注评价路径的选择、试验液的制备等因素，在进行具体的生物相容性试验时需充分考虑产品的物理化学特性与临床使用场景。结论 生物学评价是医美类医疗器械能在临床上安全应用的重要保障，需结合器械特性科学合理的进行生物学评价。

Objective To explore the key points of biological evaluation for medical aesthetic devices, ensuring their safety and efficacy in clinical applications, providing scientific evidence for industry regulation and technical review, and promoting standardized industry development. Methods Systematically analyze market-approved medical aesthetic devices, integrate domestic and international regulations and technical standards, and further investigate common issues and solutions in biocompatibility testing. Results The biological evaluation of medical aesthetic devices requires focused attention on factors such as the selection of evaluation pathways and preparation of test solutions. Specific biocompatibility testing must fully consider the devices' physicochemical properties and clinical application scenarios. Conclusion Biological evaluation is a critical safeguard for the safe clinical application of medical aesthetic devices. It must be conducted scientifically and rationally based on device characteristics to ensure compliance with safety requirements.