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定制式和患者匹配增材制造医疗器械医工交互全过程构成要素与控制方法 |
Component Elements and Control Method of the Whole Process of Interaction between Medical and manufacturing in the Customized and personalized Additional Manufacturing medical device |
投稿时间:2019-03-26 修订日期:2019-09-10 |
DOI: |
中文关键词: 增材制造医疗器械,定制式医疗器械,医工交互 |
英文关键词: Additional Manufacturing medical device,Customized and personalized medical device,Interaction between Medical and manufacturing |
基金项目:十三五国家重点研发计划课题支持 课题编号:2016YFC1103201,2016YB1101704,中国食品药品检定研究院学科带头人基金 2015X2 |
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中文摘要: |
随着人类对健康的要求提升,医疗器械的个性化需求是必然趋势。增材制造等新技术的使用为这个趋势的实现提供了可能。我国已经高度重视定制式和患者匹配式增材制造医疗器械的技术研究、产品开发和临床应用,相关技术指导原则和监管规定即将出台。医疗器械的个性化定制涉及临床诊断、影像数据、设计开发、制造等多个医工领域,因此,医工交互的规范性和交互信息有效性显得非常关键。我们首先要把握的是医工交互全过程的构成要素以及对这些要素的控制的考虑,这既是完成医疗器械个性化定制的前置条件,也是实施监管的前提。本文将以现阶段经验为基础,总结出定制式增材制造医疗器械在设计开发和制造过程中的重要环节医工交互环节应考到的基本问题。可以有效提高沟通效率,明确各方责任,同时提高数据传输的安全性和稳定性。 |
英文摘要: |
Along with the requirement of health, the personalized medical device is the main treatment in clinic. The additive manufacturing provides the realization of the personalized medical device. These years, China pay high attention to the personalized and customized medical device. And the matching technical documents will be published. During the manufacturing process of the personalized medical divice, there are sever important components. The clinical diagnosis、the data of imageology、the design and development and the manufacturing are involved in the realization of personalized medical device. The standardization and efficacy of the interaction between medical and manufacturing are vital. First we have to define the whole elements in the interaction between medical and manufacturing and the consideration of these elements. This is not only the precondition of completing individualized customization of medical devices, but also the precondition of implementing supervision. This article defined the important elements and how the elements work with each other. |
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