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医用增材制造医疗器械的质控重点与标准化工作进展

韩倩倩 李茂 王春仁 杨昭鹏

组织工程与重建外科杂志2018,Vol.14Issue(3):121-122,135,3.
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

韩倩倩 1李茂 1王春仁 1杨昭鹏1

作者信息

  • 1. 102629 北京市 中国食品药品检定研究院医疗器械检定所
  • 折叠

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)

组织工程与重建外科杂志

OACSTPCD

1673-0364

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