金属增材制造医疗器械的特点及风险防控要点

Characteristic and Risk Points of Metal Additive Manufacturing Medical Devices

近年来金属增材制造技术快速发展,因其具有一体成型、节约材料、可定制化等特点,逐渐应用于医疗器械领域.我国增材制造技术也处于世界领先水平,已有多种应用该技术的创新医疗器械产品问世.文章回顾金属增材制造技术的发展,归纳总结金属增材制造医疗器械的优势及现有应用,并针对实际生产中可能出现的风险点进行梳理,以期对企业生产安全的提高及监管部门核查效率的提升提供帮助.

In recent years,metal additive manufacturing technology has developed rapidly.Because of its integrated molding,material saving,and customization,it has gradually been used in the field of medical device.Chinese additive manufacturing technology is also at the world’s leading level,and a variety of innovative medical devices which use this technology have come out.This article reviews the development of metal additive manufacturing technology,summarizes the advantages and current applications of metal additive manufacturing medical devices,and sorts out the risk points that may occur in actual production.In order to provide assistance to the improvement of production safety of enterprises and inspection efficiency of regulatory authorities.