透析用留置针是血液净化中心常用耗材，其高分子材料导管留置血管时具有更好舒适度，赢得了医务工作者和患者认可，临床使用数量不断增加。面对该医疗器械缺少国家标准、行业标准的局面，明确其有效性、安全性关键项目，进行合理的技术评价，将保证透析用留置针在血液净化中心的安全使用。本文总结近期技术审评原则要求，介绍透析用留置针技术评价和检测要点、关键性能研究要求等，供监管、生产、技术审评、血液净化中心等单位参考。

Dialysis indwelling catheters are commonly used consumables in blood purification centers. Catheters of high-molecular-weight material provide better comfort when left in blood vessels, earning recognition from medical professionals and patients, leading to increasing clinical usage. In the face of the lack of national and industry standards for this medical device, identifying key effectiveness and safety criteria and conducting reasonable technical evaluations will ensure the safe use of dialysis catheters in blood purification centers. This article summarizes recent technical review principles, introduces key technical evaluation and testing points for dialysis indwelling catheters, as well as requirements for critical performance research, providing references for regulatory agencies, manufacturers, technical reviewers, and blood purification centers.