关于ISO 15197：2013标准新增与修订指标的分析探讨

中国药物警戒 ›› 2014, Vol. 11 ›› Issue (3): 144-146.

关于ISO 15197：2013标准新增与修订指标的分析探讨

吴传松, 董劲春

国家食品药品监督管理总局医疗器械技术审评中心,北京 100044

收稿日期:2013-08-29 修回日期:2016-02-03 出版日期:2014-03-08 发布日期:2016-02-03
作者简介:吴传松,男,硕士,助理研究员,医疗器械技术审评。

Analysis and Discussion on New and Revised Index of ISO 15197:2013 Standard

WU Chuan-song DONG Jin-chun

Center For Medical Devices Evaluation of CFDA, Beijing 100044, China

Received:2013-08-29 Revised:2016-02-03 Online:2014-03-08 Published:2016-02-03

摘要/Abstract

摘要： 国际标准组织（ISO）近期发布的《体外诊断检测系统—用于糖尿病管理的自测用血糖监测系统通用技术要求》（ISO15197：2013标准）,对系统准确度,共识误差网络（CEG）要求以及用户性能评价要求进行了修订,增加红细胞压积和干扰物质的要求等内容。本文重点对ISO15197：2013标准中新增与修订指标的编制依据及其技术参数的变化进行分析探讨。

关键词: 血糖监测系统, 系统准确度

Abstract: AbstractsInternational Organization for Standardization(ISO) recently released "Invitro diagnostic test systems- Requirements for blood-glucose monitoring systems for self-testing in managing diabetes mellitus". The new standard revised the system accuracy and the consensus network error(CEG) and the user performance evaluation, and increased the hematocrit and the interfering substances etc. This article discussed the foundation of the ISO15197 2013 standard, and analysed the difference of the new and revised technical indicators.

Key words: blood glucose monitoring systems, the system accuracy

中图分类号:

R197.39

吴传松, 董劲春. 关于ISO 15197：2013标准新增与修订指标的分析探讨[J]. 中国药物警戒, 2014, 11(3): 144-146.

WU Chuan-song DONG Jin-chun. Analysis and Discussion on New and Revised Index of ISO 15197:2013 Standard[J]. Chinese Journal of Pharmacovigilance, 2014, 11(3): 144-146.

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