3D打印技术在骨科医疗植入物方面的应用及其对民用飞机结构件适航认证的启示
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摘要
3D打印技术是一种先进的制造技术,在医疗、航空航天、汽车、模具、文化创意、教育等领域有广阔的应用前景。目前3D打印个性化骨科医疗植入物已有多起成功的应用案例,在如何通过主管部门审核方面积累了丰富的经验。民用飞机结构件与骨科医疗植入物在重要程度、审批方式、认证流程等方面有很多类似的地方,因此在进行民机3D打印结构件适航认证时可以借鉴骨科医疗植入物审批时的诸多宝贵经验。总结了3D打印骨科医疗植入物的应用现状、审批方式及面临的问题,分析了其借鉴价值,旨在为民用飞机3D打印结构件的适航认证提供参考。
As an advanced fabrication technique,3Dprinting has potential application in medical,aeronautics and astronautics industry,automobile,mould,innovation and education field,etc.Nowadays,lots of 3Dprinted bone medical implants have been applied in surgery practice.During the certification process,much precious experience has been accumulated.Civil aircraft components are somewhat similar with medical implants such as its importance,certification mode and procedure.The experiences in medical implants certification may be helpful for conducting airworthiness in civil aircraft components.In this paper,the application status,certification mode and challenge of 3Dprinted medical implants are summarized and its implication for civil aircraft components is demonstrated.
As an advanced fabrication technique,3Dprinting has potential application in medical,aeronautics and astronautics industry,automobile,mould,innovation and education field,etc.Nowadays,lots of 3Dprinted bone medical implants have been applied in surgery practice.During the certification process,much precious experience has been accumulated.Civil aircraft components are somewhat similar with medical implants such as its importance,certification mode and procedure.The experiences in medical implants certification may be helpful for conducting airworthiness in civil aircraft components.In this paper,the application status,certification mode and challenge of 3Dprinted medical implants are summarized and its implication for civil aircraft components is demonstrated.
引文
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3 王成焘.医学的3D打印革命[J].中国经济和信息化,2013(7):48.
4 汤啸天,王燎.3D打印技术与骨科植入物研发现状及其瓶颈突破思路[J].医学与法学,2015,7(6):66.
5 仰东萍,蔡宏.我国首个3D打印人体植入物获注册3D打印髋关节进入“量产”时代[N].健康报,2015.9.1:第002版综合新闻.
6 罗丽娟,余森,于振涛,等.3D打印钛合金人体植入物的应用与研究[J].钛工业进展,2015,32(5):1.
7 朱荣欣.中国医疗器械监管体系研究——以无锡为例[D].上海:同济大学,2008.
8 何韦静.我国医疗器械注册监管现状及审评体系建设研究[D].成都:成都中医药大学,2015.