3D打印技术具有个性化定制的特点，能满足医疗领域个性化、精准化的需求。从3D打印标准化角度，分析了3D打印技术国际标准研制进展与国际通用标准体系框架，梳理了3D打印现行国际标准，剖析了中国3D打印在政策、标准化技术委员会、审批注册技术规范、培训体系等方面的投入与支持，并结合国际标准化工作展望了中国从通用标准、应用标准与审批注册规范等方面推动3D打印医疗器械产业发展，通过标准化路径推进3D打印技术在医疗领域广泛应用的策略。
As a rapid prototyping technique in additive manufacturing, 3D printing has the advantage of producing patient-specific devices and enabling customized medical services. Focusing on the standards for additive manufacturing, this paper analyzes the development of its international standard and the framework of general standard system for 3D printing, and introduces the policy, technical committee, provisions for registration and training system. A roadmap for the medical device development in China through combining domestic general standard, application standard and registration testing with the international 3D printing standards is put forward to promote 3D printing in medical field.
[1] 朱艳青, 史继富, 王雷雷, 等. 3D打印技术发展现状[J]. 制造技术与机床, 2015(12):50-57. Zhu Yanqing, Shi Jifu, Wang Leilei, et al. Current status of the three-dimensional printing technology[J]. Manufacturing Technology & Machine Tool, 2015(12):50-57.
[2] Wong K V, Hernandez A. A review of additive manufacturing[J]. ISRN Mechanical Engineering, 2012, 2012:1-10.
[3] 王灿友, 苏秦, 李涤尘. 3D打印标准化探究[J]. 信息技术与标准化, 2015(12):18-21. Wang Chanyou, Su Qin, Li Dichen. Discussion on standardization establishment of 3D printing[J]. Information Technology & Standardization, 2015(12):18-21.
[4] 余冬梅, 张建斌. 3D打印:定制化医疗修复[J]. 金属世界, 2016(1):21-28. Yu Dongmei, Zhang Jianbin. 3D printing:customized medical repair[J]. Metal World, 2016(1):21-28.
[5] 邓滨, 欧阳汉斌, 黄文华. 3D打印在医学领域的应用进展[J]. 中国医学物理学杂志, 2016, 33(4):389-392. Deng Bin, Ouyang Hanbin, Huang Wenhua. Application progress of three-dimensional printing in medical field[J]. Chinese Journal of Medical Physics, 2016, 33(4):389-392.
[6] 罗丽娟, 余森, 于振涛, 等. 3D打印钛及钛合金医疗器械的优势及临床应用现状[J]. 生物骨科材料与临床研究, 2015, 12(6):72-75. Luo Lijuan, Yu Sen, Yu Zhentao, et al. The advantage and clinical application of titanium medical devices prepared by 3D printing[J]. Orthopaedic Biomechanics Materials and Clinical Study, 2015, 12(6):72-75.
[7] 王微. 3D打印生命阶梯, 我们走到哪一步了[J]. 科技导报, 2016, 34(13):9-9. Wang Wei. 3D printing life ladder, Which step do we have arrived[J]. Science & Technology Review, 2016, 34(13):9-9.
[8] 孙小磊, 汪缨, 张晖, 等. 3D打印技术在临床中的应用现状及展望[J]. 中国医疗设备, 2017, 32(1):99-102. Sun Xiaolei, Wang Ying, Zhang Hui, et al. Clinical application status and prospect of 3D printing technology[J]. China Medical Devices, 2017, 32(1):99-102.
[9] 管吉, 杨树欣, 管叶, 等. 3D打印技术在医疗领域的研究进展[J]. 中国医疗设备, 2014, 29(4):71-72, 135. Guan Ji, Yang Shuxin, Guan Ye, et al. Research progress of 3D printing technology in medical domain[J]. China Medical Devices, 2014, 29(4):71-72, 135.
[10] Conese M. Bioprinting:A further step to effective regenerative medicine and tissue engineering[J]. Advancements in Genetic Engineering, 2014, doi:10.4172/2169-0111.1000e112.
[11] 韩倩宜, 李淑萍, 肖雄夫, 等. 3D打印技术在植入式医疗器械中的应用[J]. 科技导报, 2017, 35(2):72:79. Han Qianyi, Li Shuping, Xiao Xiongfu, et al. 3D printing:The application in medicine devices[J]. Science & Technology Review, 2017, 35(2):72-79.
[12] 赖炎鑫, 朱鹏志."3D打印"在医疗器械领域中的现状及前景展望[J]. 中国医疗器械信息, 2017(10):112-114. Lai Yanxin, Zhu Pengzhi. Clinical application status and prospect of 3D printing in medical device[J]. China Medical Device Information, 2017(10):112-114.
[13] 蒋海洪, 李晓. 对3D打印医疗器械管理的政策建议[J]. 科技导报, 2017, 35(14):11-12. Jiang Haihong, Li Xiao. Policy suggestions on the management of 3D printing in medical devices[J]. Science & Technology Review, 2017, 35(14):11-12.
[14] 钟新周, 聂婷, 陈玲, 等. 发展3D打印医学产品的问题与对策[J]. 经济研究导刊, 2016(8):57-58. Zhong Xinzhou, Nie Ting, Chen Ling, et al. Problems and countermeasures of developing 3D printing medical products[J]. Economic Research Guide, 2016(8):57-58.
[15] ASTM. Committee F42 on additive manufacturing technologies[EB/OL].[2018-03-16]. https://www.astm.org/COMMITTEE/F42.htm.
[16] ISO. Standards catalogue:ISO/TC261 Additive manufacturing[EB/OL].[2018-03-16]. https://www.iso.org/committee/629086/x/catalogue/.
[17] SASAM. Additive Manufacturing:SASAM standardisation roadmap[R]. AM Platform, 2015.
[18] FDA. Technical considerations for Additive Manufactured medical devices[S]. Food and Drug Administration, 2017.
[19] Fitzgerald S. FDA approves first 3D-printed epilepsy drug experts assess the benefits and caveats[J]. Neurology Today, 2015, 15(18):26-27.
[20] 工业和信息化部. 关于印发《国家增材制造产业发展推进计划(2015-2016年)》的通知(工信部联装
[2015] 53号)[EB/OL]. (2015-02-11)[2018-03-16]. http://www.miit.gov.cn/n1146295/n1652858/n1652930/n3757018/c3763342/content. html.
[21] 国务院. 国务院关于印发《中国制造2025》的通知(国发
[2015] 28号)[A/OL]. (2015-05-08)[2018-03-16]. http://www.gov.cn/zhengce/content/2015-05/19/content_9784.htm.
[22] 陕西省工业和信息化厅. 国家增材制造创新中心(筹)落户陕西[EB/OL]. (2017-01-04)[2018-03-16]. http://www.sxgxt.gov.cn/zwhd/36501.jhtml.
[23] 工业和信息化部. 十二部门关于印发《增材制造产业发展行动计划(2017-2020年)》的通知(工信部联装
[2017] 311号)[A/OL]. (2017-11-30)[2018-03-16]. http://www.miit.gov.cn/n1146290/n4388791/c5956898/content.html.
[24] 国家食品药品监督管理总局医疗器械技术审评中心. 关于对《定制式增材制造医疗器械注册技术审查指导原则》(征求意见稿)公开征求意见的通知[EB/OL]. (2018-02-26)[2018-03-16]. http://www.cmde.org.cn/CL0004/6954.html.
[25] 国家食品药品监督管理总局. 国家食品药品监督管理总局关于发布需进行临床试验审批的第三类医疗器械目录的通告(2014年第14号)[A/OL]. (2014-08-25)[2018-03-16]. http://www.sda.gov.cn/WS01/CL0087/105374.html.
