Plain metallic biomaterials:opportunities and challenges  

作　　者：Jiazhen Zhang Bao Zhai Jintao Gao Zheng Li Yufeng Zheng Minglong Ma Yongjun Li Kui Zhang Yajuan Guo Xinli Shi Bin Liu Guobiao Gao Lei Sun 

机构地区：[1]Center for Medical Device Evaluation,National Medical Product Administration,Beijing 100081,China [2]Guangdong-Hong Kong-Macao Greater Bay Area,Center for Medical Device Evaluation and Inspection of NMPA,Shenzhen 518045,China [3]School of Materials Science and Engineering,Peking University,Beijing 100871,China [4]State Key Laboratory of Nonferrous Metals and Process,GRINM Group Corporation Limited(General Research Institute for Nonferrous Metals),Beijing 100088,China

出　　处：《Regenerative Biomaterials》2023年第1期140-147,共8页再生生物材料（英文版）

基　　金：supported by the first batch of Chinese Drug Regulatory Science Action Plan(Regulatory science research on new materi-als for medical device);This work was also supported by the sec-ond batch(“5.5 Research on technical evaluation of recombinant collagens,cartilage repair materials and antimicrobial orthope-dic/dental materials”)of Chinese Drug Regulatory Science Action Plan of NMPA.

摘　　要：The‘plainification of materials’has been conceptualized to promote the sustainable development of materials.This perspective,for the first time in the field of biomaterials,proposes and defines‘plain metallic biomaterials(PMBs)’with demonstrated research and application case studies of pure titanium with high strength and toughness,and biodegradable,fine-grained and high-purity magnesium.Then,after discussing the features,benefits and opportunities of PMBs,the challenges are analyzed from both technical and regulatory aspects.Regulatory perspectives on PMB-based medical devices are also provided for the benefit of future research,development and commercialization.

关 键 词：plainification metallic biomaterials regulatory science medical devices pure titanium high-purity magnesium 

分 类 号：R318.08[医药卫生—生物医学工程]