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

doi:10.3969/j.issn.1673-0364.2018.03.001

Journal of Tissue Engineering and Reconstructive Surgery ›› 2018, Vol. 14 ›› Issue (3): 121-135.doi: 10.3969/j.issn.1673-0364.2018.03.001

• Review • Next Articles

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

HAN Qianqian,LI Mao,WANG Chunren,YANG Zhaopeng

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)

Abstract

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

CLC Number:

R318.6

HAN Qianqian,LI Mao,WANG Chunren,YANG Zhaopeng. The Progress of Standardization and Quality Control of Additive Manufacturing Medical Device[J]. Journal of Tissue Engineering and Reconstructive Surgery, 2018, 14(3): 121-135.

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