首页|医用丝素蛋白材料在医疗器械中的应用及其审评关注点

医用丝素蛋白材料在医疗器械中的应用及其审评关注点

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源自蚕丝的丝素蛋白医用材料在医疗器械领域的应用成为研究热点.丝素蛋白材料主文档备案日益增多,一批丝素蛋白医疗器械获批上市,表现出良好的应用前景.文章介绍了医用丝素蛋白材料在医疗器械中的研究和应用,境内外医疗器械产品上市情况,及丝素蛋白敷料类产品的审评关注点,供行业参考.
Application of Silk Fibroin in Medical Devices and Its Evaluation Focus
The application of silk fibroin derived from silk has become a research hotspot in the field of medical devices.The main document filing of silk fibroin is gradually increasing,and a batch of silk fibroin medical devices have been approved for market,showing good application prospects.This article introduces the investigation and application of silk fibroin in medical devices,the market situation of medical device products at home and abroad,and the evaluation focus of silk fibroin dressings,for reference by relevant industries.

silk fibroinmedical devicesmedicated dressingsmedical devices evaluation

郑超、谢昕、张坤智、晁园、王越、齐伟明

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浙江省医疗器械审评中心 (浙江 杭州 310009)

丝素蛋白 医疗器械 医用敷料 医疗器械审评

2024

中国医疗器械信息
中国医疗器械行业协会

中国医疗器械信息

影响因子:0.375
ISSN:1006-6586
年,卷(期):2024.30(15)