应用纳米材料的医疗器械研究现状与生物学评价探讨

Research Status of Nanomaterial Medical Device and Discussion on Biological Evaluation

摘要: 近年来，我国在基础纳米医学、纳米毒理学、纳米生物学等研究领域取得了重大进展，纳米技术被不断应用于生物材料和医疗器械领域，越来越多应用纳米材料的医疗器械被研发和生产。为了对纳米材料医疗器械的学术研究和产业发展有更全面和准确的了解，该研究梳理了医疗器械中常用的纳米材料以及国内外对应用纳米材料的医疗器械的监管情况，探讨了目前该类医疗器械在生物学评价方面面临的挑战，以期为相关产品的安全性评价与研究提供思路。

Abstract: In recent years, China has made great progress in basic nanomedicine, nanotoxicology and nanobiology research. Nanotechnology has been continuously applied in biomaterial and medical device, more and more medical devices applying nanomaterials are developed and manufactured. In order to gain more comprehension and accurate understanding of the research and industrial development in nanobiomaterial medical devices, this study reviewed the common nanomaterial in medical devices and the regulatory situation of nanomaterial medical devices at home and abroad, and discussed the current challenges in biological evaluation of nanomaterial medical devices, with a view to providing ideas for the safety evaluation and research of related products.