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科技导报 |科技建议 2017 , 35 (14) : 11 -12
对3D打印医疗器械管理的政策建议
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蒋海洪1, 李晓2
作者信息
    1. 上海健康医学院;
    2. 国家食品药品监督管理总局高级研修学院
作者简介:
蒋海洪,上海健康医学院,讲师;李晓,国家食品药品监督管理总局高级研修学院,助教
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    出版时间: 2017-07-28
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    3D打印技术,又称为增材制造技术,是一种通过三维数据,通常由逐层加工的方式结合材料以制造构件的技术。近年来,随着技术的发展,3D打印已率先在医疗领域获得应用上的突破。这主要因为医疗行业个性定制化需求显著,鲜有标准的量化生产,而个性化、小批量和高精度恰是3D打印技术的优势所在[1]。目前,3D打印在医疗器械领域的应用主要包括:体外医疗器械,如医疗模型、假肢、齿科手术模板等;个性化植入物,如颅骨修复、颈椎人工椎体及人工关节等;常规植入物,如关节柄的表面修饰、种植牙、补片等;加入细胞3D打印人体器官等[2]
    蒋海洪, 李晓. 对3D打印医疗器械管理的政策建议. 科技导报, 2017 , 35 (14) : 11 -12 .

      本研究受中国药品监督管理研究会“3D打印医疗器械对监管法规的影响研究”项目资助。

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    • 首发时间:2017-07-29
    • 出版时间:2017-07-28
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    2种不同金属材料的力学参数

    Family
    属数
    Number of
    genus
    种数
    Number of
    species
    占总种数比例
    Percentage of
    total species (%)

    Genus
    种数
    Number of
    species
    占总种数比例
    Percentage of total
    species (%)
    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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