ISO 17511临床检验量值溯源国际标准修订解读

doi:10.3877/cma.j.issn.2095-5820.2015.02.007

中华临床实验室管理电子杂志 ›› 2015, Vol. 03 ›› Issue (03) : 168 -170. doi: 10.3877/cma.j.issn.2095-5820.2015.02.007

所属专题：文献；

指南与规范

ISO 17511临床检验量值溯源国际标准修订解读

王军^†, 刘毅

收稿日期:2015-07-16 出版日期:2015-08-28
通信作者: 王军

Received:2015-07-16 Published:2015-08-28

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[1]	ISO. ISO 17511:2003, In vitro diagnostic medical devices-measurement of quantities in samples of biological origin-metrological traceability of values assigned to calibrators and control materials. ISO, 2003.
[2]	杨振华. 建设我国检验医学参考体系任重道远[J]. 临床检验, 2012, 30(10):734–736.
[3]	陈文祥, 申子瑜, 郭健. 临床检验量值溯源中的重要术语与概念及有关问题[J]. 中华检验医学杂志, 2005, 28(2):142–146.
[4]	陈宝荣 . 临床检验结果量值溯源存在的问题与思考[J]. 临床检验杂志, 2012, 30(12):943–945.
[5]	JCGM. JCGM 200:2012, International vocabulary of metrology-Basic and general concepts and associated terms (VIM). JCGM, 2012.
[6]	JCGM. JCGM 100:2008, Evaluation of measurement data—guide to the expression of uncertainty in measurement. JCGM, 2008.
[7]	ISO. ISO 18153:2003, In vitro diagnostic medical devices-measurement of quantities in samples of biological origin-metrological traceability of values catalytic concentration of enzymes assigned to calibrators and control materials. ISO, 2003.
[8]	ISO. ISO Guide 34: 2009, General requirements for the Conpetence of Reference Material Producers. ISO, 2009.
[9]	ISO. ISO 15194:2009, In vitro diagnostic medical devices-measurement of quantities in samples of biological origin-requirements for certified reference materials and the content of supporting documentation. ISO, 2009.
[10]	ISO. ISO 15193:2009, In vitro diagnostic medical devices-measurement of quantities in samples of biological origin-requirements for content and presentation of reference measurement procedures. ISO, 2009.

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