纳米银材料的安全性评价与管理规范现状初探-中国材料进展

文章信息/Info

Title:: Current Status of the Safety Evaluation and Regulation for Nanosilver-containing Materials

摘要:: 纳米银具有显著优于银离子化合物的杀菌性能，近年来，产业界和学术界对利用纳米银提高生物医药、电子、家用产品的抗菌性能方面进行了广泛的探索和开发。但是，随着纳米银生产数量的增加和各种医用与日用产品进入市场，人们接触纳米银机会也随之增多，纳米银对于健康、环境和安全的影响受到了学术界及政府管理机构的密切关注。纳米银的生物安全性、临床应用必要性和有效性、在产品中的结合方式与结合稳定性的检测与评价标准、以及含纳米银医疗器械的管理规范是需要认真而慎重考虑的关键问题。本文概要介绍了纳米银的毒理学研究进展，总结和评述了国际上对于纳米银及其他纳米材料用于生物医药和日常生活用品的安全性评价标准和监管政策现状。

Abstract:: The nanosilver has been widely explored for being used as a powerful antibacterial agent in medical healthcare, electronic and household products due to its much stronger antimicrobial performance than conventional silver compounds. Meanwhile, the increasing exposure of nanosilver raises the serious concern with impacts upon the health, safety, and environment of the nanosilver-containing products. In the development of nanosilver-containing products, the bio-safety, necessity and effectiveness in clinical practices, and standardization and regulation should be carefully considered. In this article, the antimicrobial mechanism and the research progress in nanosilver toxicology was introduced. The standardization for physicochemical characterization and safety evaluation for nanomaterials as well as the regulation was addressed.