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关于ISO 15197:2013标准新增与修订指标的分析探讨 被引量：6

Analysis and Discussion on New and Revised Index of ISO 15197:2013 Standard
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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。 International 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.
作者 吴传松 董劲春
机构地区 国家食品药品监督管理总局医疗器械技术审评中心
出处 《中国药物警戒》 2014年第3期144-146,150,共4页 Chinese Journal of Pharmacovigilance
关键词 血糖监测系统 系统准确度 blood glucose monitoring systems the system accuracy
分类号 R197.39 [医药卫生—卫生事业管理]
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参考文献16

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  • 3Hasslacher C, Kulozik F, Platten P. Accuracy of Self Monitoring Blood Glucose Systems in a Clinical Setting:. Application of New Planned ISO Standards[J] .Clinical Laboratory,2013,59 (7-8): 727- 733.
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共引文献5

同被引文献50

  • 1张一波.糖尿病患者低血糖的预防和治疗[J].中华护理杂志,2006,41(4):380-381. 被引量：55
  • 2ISO.In vitro diagnostic test systems-Requirements for bloodglucosemonitoringsystems for self-testing in managing diabetes mellitus[EB/OL].(2013-05-14)[2013-08-26]http://www.iso.org/iso/home/store/catalogue_ics/catalogue_detail_ics.htm? csnumber=54976.
  • 3ISO.More accurate self-testing results for diabetes Patients with new ISO standard[EB/OL].(2013-06-19) http:// www.iso.org/iso/home/news _ index/news _ archive/news.htm? refid=Ref1749.
  • 4Danaei G,Finucane MM,Lu Y,et al.National,regional,and global trends in fasting plasma glucose and diabetes prevalence since 1980:systematic analysis of health examination surveys and epidemiological studies with 370 country-years and 2.7 million participants.Lancet,2011,378:31-40.
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  • 6Klonoff DC.The food and drug administration is now preparing to establish tighter performance requirements for blood glucose monitors.J Diabetes Sci Technol,2010,4:499-504.
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  • 10Hasslacher C,Kulozik F,Platten P.Accuracy of self monitoring blood glucose.systems in a clinical setting:application of new planned ISO-standards.Clini Lab,2013,59:727-733.

引证文献6

二级引证文献25

中国药物警戒
2014年 第3期

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