组织工程与重建外科杂志2018,Vol.14Issue(3):121-122,135,3.DOI:10.3969/j.issn.1673-0364.2018.03.001
医用增材制造医疗器械的质控重点与标准化工作进展
The Progress of Standardization and Quality Control of Additive Manufacturing Medical Device
摘要
Abstract
3D printing is used in the manufactory of medical device.This technology could be used in the fabrication of dental medical device,orthopedic and cardiovascular medical device.Because of the uniqueness of this technology,the research of quality control should cover raw material,the process control,facility,data transmission and risk control.Besides the quality control technology,it is important to set up standards.The process control and standardization could improve the risk control and quality of additive manufacturing in medical area.In this paper,the progress of standardization and quality control of additive manufacturing medical device was reviewed.关键词
增材制造/医疗器械/标准/质量评价Key words
Additive manufacturing/Medical device/Standard/Quality evaluation分类
医药卫生引用本文复制引用
韩倩倩,李茂,王春仁,杨昭鹏..医用增材制造医疗器械的质控重点与标准化工作进展[J].组织工程与重建外科杂志,2018,14(3):121-122,135,3.基金项目
十三五重点研发计划(2016YFC1103202,2016YFC1103201) (2016YFC1103202,2016YFC1103201)
中检院学科带头人基金(2015X2). (2015X2)