组织工程与重建外科杂志

组织工程与重建外科杂志 ›› 2018, Vol. 14 ›› Issue (3): 121-135.doi: 10.3969/j.issn.1673-0364.2018.03.001

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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   

  1. 中国食品药品检定研究院医疗器械检定所
  • 收稿日期:2018-03-19 发布日期:2020-07-23
  • 作者简介:王春仁（E—mail：chunrenwang@263．net）;杨昭鹏（E-mail：Yangzp@nifdc．org．cn）。

The Progress of Standardization and Quality Control of Additive Manufacturing Medical Device

HAN Qianqian,LI Mao,WANG Chunren,YANG Zhaopeng   

  1. Medical Device Control, National Institute of Food and Drug Control, CFDA
  • Received:2018-03-19 Published:2020-07-23
  • Contact: 十三五重点研发计划(2016YFC1103202，2016YFC1103201)；中检院学科带头人基金(2015X2)

摘要： 可利用3D打印技术制造的医疗器械种类包括齿科器械、骨科器械和心血管器械等。由于技术的独特性,应该从工艺全环节对3D打印的医疗器械展开质量控制研究,涵盖原材料、工艺验证、设备、数据传输和风险管理等。此外,也有必要建立评价方法的相关标准和质量控制标准。质量控制研究和标准化工作有助于推进增材制造技术在医疗领域的安全有效应用。本文对医用增材制造医疗器械质量控制的关键点和标准化工作的进展进行阐述,以期为该行业的研发提供帮助。

关键词: 增材制造, 医疗器械, 标准, 质量评价

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.

Key words: Additive manufacturing, Medical device, Standard, Quality evaluation

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