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2013年国际标准化组织(ISO)发布ISO 15197:2013标准,2014年美国食品药品监督管理局(FDA)发布指导草案(OTC),均对自测用血糖监测(SMBG)系统性能评价提出更加严格准确度要求。本文主要介绍这两个规范性文件对SMBG系统准确度的评价方法,以了解目前国际上对SMBG系统准确度的要求。
In 2013, ISO 15197: 2013 was promulgated by the International Organization for Standardization (ISO) and in 2014, the US Food and Drug Administration (FDA) issued a draft guidance on the performance evaluation of self-test blood glucose monitoring (SMBG) system. Degree requirements. This article mainly introduces the evaluation methods of these two normative documents on the accuracy of the SMBG system to understand the current international requirements for the accuracy of the SMBG system.