期刊文献+
任意字段
题名或关键词
题名
关键词
文摘
作者
第一作者
机构
刊名
分类号
参考文献
作者简介
基金资助
栏目信息

ISO 17511临床检验量值溯源国际标准修订解读 被引量：4

原文传递
导出
摘要 ISO 17511体外诊断医疗器械生物样品中量的测量校准品和控制物质赋值的计量学溯源性（in vitro diagnostic medical devices-measurement of quantities in biological samples-metrological traceability of values assigned to calibrators and control materials）第1版于2003年发布，
作者 王军 刘毅
机构地区 北京市医疗器械检验所
出处 《中华临床实验室管理电子杂志》 2015年第3期168-170,共3页 Chinese Journal of Clinical Laboratory Management(Electronic Edition）
关键词 国际标准 量值溯源 临床检验 解读 修订 生物样品 医疗器械 体外诊断
分类号 R446 [医药卫生—诊断学]
  • 相关文献

参考文献10

  • 1ISO. ISO 17511:2003, In vitro diagnostic medical devices-measurement of quantities in samples of biological origin-metrologicaltraceability 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].临床检验杂志,2012,30(10):734-736. 被引量：3
  • 3陈文祥,申子瑜,郭健,杨振华.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. 被引量：35
  • 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. 被引量：17
  • 5JCGM. JCGM 200:2012, International vocabulary of metrology-Basicand general concepts and associated terms (VIM). JCGM, 2012.
  • 6JCGM. JCGM 100:2008, Evaluation of measurement data—guide tothe expression of uncertainty in measurement. JCGM, 2008.
  • 7ISO. ISO 18153:2003, In vitro diagnostic medical devices-measurement of quantities in samples of biological origin-metrologicaltraceability of values catalytic concentration of enzymes assigned tocalibrators and control materials. ISO, 2003.
  • 8ISO. ISO Guide 34: 2009, General requirements for the Conpetence ofReference Material Producers. ISO, 2009.
  • 9ISO. ISO 15194:2009, In vitro diagnostic medical devices-measurement of quantities in samples of biological origin-requirementsfor certified reference materials and the content of supportingdocumentation. ISO, 2009.
  • 10ISO. ISO 15193:2009, In vitro diagnostic medical devices-measurement of quantities in samples of biological origin-requirementsfor content and presentation of reference measurement procedures.ISO, 2009.

二级参考文献11

  • 1International Organization for Standardization. In Vitro Diagnostic Medical Devices- Measurement of Quantities in Samples of Biological Origin-Description of Reference Materials. ISO 15194, 2003.
  • 2International Organization for Standardization. Clinical Laboratory Medicine-Requirements for Reference Measurement Laboratories. 1SO 15195,2003.
  • 3International Organization for Standardization. General Requirements for the Competence of Testing and Calibration Laboratories. ISO 17025, 1999.
  • 4International Organization for Standardization. Medical Laboratories-Particular Requirements for Quality and Competence. ISO 15189, 2003.
  • 5Dybkaer R. Vocabulary for use in measurement procedures and description of reference materials in laboratory medicine. Eur J Clin Chem Clin Biochem ,1997, 35 : 141-173.
  • 6JJF1001—1998.通用计量术语及定义.中华人民共和国国家计量技术规范.[S].国家质量技术监督局,..
  • 7International Organization for Standardization. In Vitro Diagnostic Medical Devices-Measurement of Quantities in Samples of Biological Origin -Metrological Traceability of Values Assigned to Calibrators and Control Materials. ISO 17511. 2003.
  • 8International Organization for Standardization. In Vitro Diagnostic Medical Devices- Measurement of Quantifies in Samples of Biological Origin-Metrological Traceability of Values Catalytic Concentration of Enzymes Assigned to Calibrators and Control Materials. 1SO 18153, 2003.
  • 9International Organization for Standardization. In Vitro Diagnostic Medical Devices- Measurement of Quantities in Samples of Biological Origin-Presentation of Reference Measurement Procedures. ISO 15193, 2003.
  • 10吕京,陈宝荣,史光华,邵燕,胡滨,李月玲,孙慧颖.利用代表样品评定常规检验结果的不确定度[J].临床检验杂志,2011,29(9):643-649. 被引量：5

共引文献51

同被引文献30

引证文献4

二级引证文献9

中华临床实验室管理电子杂志
2015年 第3期

相关作者

内容加载中请稍等...

相关机构

内容加载中请稍等...

相关主题

内容加载中请稍等...

浏览历史

内容加载中请稍等...
;
使用帮助 返回顶部