3D打印医疗器械标准现状和产品质量控制研究

Additive Manufactured Medical Devices––Application, Standardization and Quality Control

增材制造技术(Additive Manufacturing,AM),即3D打印技术的出现和成熟促进了第四代智能医疗器械的产生和商业化。然而,该技术发展时间短,其制造原理较传统工艺有革命性变化,科研和生产经验匮乏,产品性能检验和评价领域缺乏标准,对产品的质量控制要点了解尚不全面。这种现状不仅为产品发展带来了巨大的困难,而且制约了产品上市的步伐,影响了行业发展。本文就增材制造医疗器械的市场现状及相关标准情况进行了概述,并对其产品质量控制要点进行详细分析。

The development of additive manufacturing （AM） raises the curtain for the 4th generation smart medical devices. However, it is yet in its infant stage with evolutionary changes in the fundamental mechanism. Research and manufacturing experiences are scarce compared to traditional manufacturing techniques. Standards for product properties and inspection are still being flamed. These together with the poor understanding of product quality control and process validation and verification severely impede the development of additive manufactured medical devices, especially in their commercialization. In this study, the latest development of additive manufactured medical device markets and relevant standards are described, and the major considerations concerning product quality control discussed.