Nanomaterials when exposed to biological systems may produce oxidative stress, genotoxicity, and carcinogenicity, as nanoparticle toxicity is speculated to be different from larger particles of the same chemical composition due to the change of their physical properties from their smaller size and resultant higher surface area. Regulatory frameworks have become established to address the influx of nanomaterials to assess the potential benefit to human health but also where there is a risk to both human health and the environment. This article focuses on these regulatory frameworks, including the risk from inhalation, where these changes have already been implemented and reflected in the revised Organisation for Economic Co-operation and Development OECD 412 and OECD 413 guidelines as additional investigations and endpoints have been added to determine the risk posed by this novel group of materials. Integr Environ Assess Manag 2021;17:1098–1104. © 2021 SETAC

中文翻译：

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包括医疗器械在内的纳米材料的监管和临床前要求状态概述

纳米材料在暴露于生物系统时可能会产生氧化应激、遗传毒性和致癌性，因为纳米颗粒的毒性被推测与具有相同化学成分的较大颗粒不同，因为它们的物理性质发生了变化，因为它们的尺寸较小，因此表面积较大。已经建立了监管框架来解决纳米材料的涌入，以评估对人类健康的潜在益处以及对人类健康和环境都存在风险的情况。本文重点介绍这些监管框架，包括吸入风险、Integr Environ Assess Manag 2021；17：1098-1104。© 2021 SETAC