医学实验室认可与测量不确定度：ISO 15189:2012对测量不确定度要求的改变

doi:10.3877.cma.j.issn.2095-5820.2014.03.008

中华临床实验室管理电子杂志 ›› 2014, Vol. 02 ›› Issue (03) : 166 -168. doi: 10.3877.cma.j.issn.2095-5820.2014.03.008

实验室认可

医学实验室认可与测量不确定度：ISO 15189:2012对测量不确定度要求的改变

杨振华¹^,^†(

)

1.100730 北京，卫生部临床检验中心

收稿日期:2014-08-02 出版日期:2014-08-28
通信作者: 杨振华

Accreditation of medical laboratory and measurement uncertainty: the changes of ISO15189:2012 requirement for measurement uncertainty

Zhenhua Yang¹^,^†()

1.National Center for Clinical Laboratories, Beijing 100730, China

Received:2014-08-02 Published:2014-08-28
Corresponding author: Zhenhua Yang

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杨振华. 医学实验室认可与测量不确定度：ISO 15189:2012对测量不确定度要求的改变[J/OL]. 中华临床实验室管理电子杂志, 2014, 02(03): 166-168.

Zhenhua Yang. Accreditation of medical laboratory and measurement uncertainty: the changes of ISO15189:2012 requirement for measurement uncertainty[J/OL]. Chinese Journal of Clinical Laboratory Management(Electronic Edition), 2014, 02(03): 166-168.

本文对比了ISO 15189:2007年第2版和2012年第3版对评定测量不确定度的要求，发现新版对测量不确定度的要求有重要修改和添加。贯彻ISO15189:2012新版要求将有力推动医学实验室对测量不确定度的理解和评估。

关键词: 测量不确定度, ISO 15189

This paper compares the requirement of measurement uncertainty in the 2nd edition ISO15189:2007 with the 3rd edition, ISO15189:2012. There are important changes and addition of new contents in the 3rd edition. Implementing the requirement in new edition would promote the medical laboratory to understand and estimate the measurement uncertainty.

Key words: Measurement uncertainty, ISO 15189

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2	International Organization for Standardization (ISO)/ International Electrotechnical Commission (IEC). ISO/IEC Guide 98-3:2008.Uncertainty of measurement - Part 3: Guide to the expression of uncertainty in measurement (GUM: 1995). http://www.bipm.org.
3	The expression of uncertainty in testing, LAB 12, United Kingdom Accreditation Service (UKAS), 2000. http://www.ukas.com.
4	中国合格评定国家认可委员会. CL 02-2013医学实验室质量和能力认可准则[S]. http://www.cnas.org.cn.
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