摘要
该文通过对3D打印过程各阶段中所使用软件及其作用进行描述,讨论了当3D打印运用于医疗器械生产时,对相关软件监管的建议。对于具有明确医疗用途的软件建议进行注册,对打印生产过程中所使用的软件则需要进行与打印产品的风险相适应的验证。
This article describes softwares and their functions in each phase of 3D printing process in medical device production,and gives the advices on supervision.For software with specific medical purposes,the registration of the software should be carried out.The softwares used in the printing process need to be verified according to the corresponding risk.
作者
朱颖峰
郑海音
ZHU Yingfeng;ZHENG Haiyin(Center for Certification&Evaluation,SHFDA,Shanghai,200020;Shanghai Hospital of Traditional Chinese Medicine,Shanghai,200071)
出处
《中国医疗器械杂志》
2018年第2期125-128,共4页
Chinese Journal of Medical Instrumentation
关键词
3D打印
医疗器械
软件
监管
3D printing
medical device
software
supervision
