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标准化助推3D打印在医疗领域的应用
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陈斌
作者信息
    机械工业仪器仪表综合技术经济研究所, 北京 100055
作者简介:
陈斌,博士,研究方向为医疗设备技术,电子信箱:chenbin@instrnet.com
Promoting 3D printing application in medical field by standardisation
  • CHEN Bin
  • Affiliations
      Instrumentation Technology & Economy Institute, Beijing 100055, China
    出版时间: 2019-03-13 doi: 10.3981/j.issn.1000-7857.2019.05.004
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    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。
    3D打印  /  医疗器械  /  标准化  /  审批注册
    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.
    3D printing  /  medical device  /  standardization  /  registration
    陈斌. 标准化助推3D打印在医疗领域的应用. 科技导报, 2019 , 37 (5) : 31 -38 . DOI: 10.3981/j.issn.1000-7857.2019.05.004
    CHEN Bin. Promoting 3D printing application in medical field by standardisation[J]. Science & Technology Review, 2019 , 37 (5) : 31 -38 . DOI: 10.3981/j.issn.1000-7857.2019.05.004

      国家重点研发计划项目(2017YFC0111003)

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    doi: 10.3981/j.issn.1000-7857.2019.05.004
    • 接收时间:2018-03-28
    • 首发时间:2019-04-01
    • 出版时间:2019-03-13
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    • 收稿日期:2018-03-28
    • 修回日期:2018-12-20
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    鹅膏菌科Amanitaceae 2 11 5.26 鹅膏菌属 Amanita 10 4.78
    小菇科 Mycenaceae 2 12 5.74 丝盖伞属 Inocybe 5 2.39
    多孔菌科 Polyporaceae 8 14 6.70 蜡蘑属 Laccaria 5 2.39
    红菇科 Russulaceae 3 23 11.00 小皮伞属 Marasmius 6 2.87
    小菇属 Mycena 11 5.26
    光柄菇属 Pluteus 5 2.39
    红菇属 Russula 17 8.13
    栓菌属 Trametes 5 2.39
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