医疗器械大动物实验研究进展
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1.无锡明慈心血管病医院;2.江苏美凤力医疗科技有限公司

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泰州市科技支撑计划(社会发展)项目(TS202205)


Research progress in large - scale animal experimental research on medical devices
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Affiliation:

1.Wuxi Mingci Cardiovascular Hospital;2.Jiangsu Medphoenix Medical Technology Co., Ltd

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Taizhou Science and Technology Support Program (Social Development) Project(TS202205)

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    摘要:

    随着我国成为全球医疗器械的第二大市场,国产医疗器械行业也随之不断发展。大动物研究作为医疗器械临床前评价的重要环节,直接影响着医疗器械的研究和应用。大动物因其体型、解剖结构、生理功能等方面与人类更加接近,被广泛用于医疗器械安全性和可行性的评估。在大动物实验研究中,选择适合的实验动物和建立合适的动物疾病模型是保证实验顺利进行的基础。本文对医疗器械大动物实验研究中实验动物的选择和疾病模型的建立进行了系统梳理,指出了现有问题和不足,为医疗器械大动物实验研究提供了参考。

    Abstract:

    As China has become the second largest market for medical devices in the world, the domestic medical device industry has been growing. As an important part of preclinical evaluation of medical devices, large animal research directly affects the research and application of medical devices. Large animals are widely used in the evaluation of safety and feasibility of medical devices because they are closer to humans in terms of body size, anatomical structure and physiological functions. In large animal experimental research, the selection of suitable experimental animals and the establishment of suitable animal disease models are the basis for ensuring the smooth progress of experiments. In this paper, the selection of experimental animals and the establishment of disease models in medical device large animal experimental research are systematically sorted out, and the existing problems and deficiencies are pointed out.

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  • 收稿日期:2024-01-23
  • 最后修改日期:2024-04-08
  • 录用日期:2024-12-19
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