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国境卫生检疫实验室的量值溯源问题

Traceability of Measurements in the Lab of Frontier Health and Quarantine
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摘要 目的介绍量值溯源的基本概念及质量保证中的作用,分析卫生检疫实验室量值溯源工作的现状及相关问题。方法结合卫生检疫实验室标准化建设的实践,对量值溯源的各种标准、要求和文献进行综述分析。结果量值溯源是检测结果与公认标准联系的过程,通过一系列对比测量而实现,是实验室标准化建设、质量保证的重要手段。目前,卫生检疫实验室的量值溯源工作还处于初始阶段,由于生物样品的复杂性,只有少数项目有较完整的参考系统,另外,常规测量过程的特异性问题和参考物质的基质效应,也增加了该类实验室量值溯源的复杂程度。结论量值溯源作为质量保证的手段受到越来越多的重视,卫生检疫实验室应结合实际情况,建立起必要的参考系统。 Objective To introduce the initial concept of traceability of measurements and its effect on quality assurance, and analyze the fact and problem of traceability of measurements in the lab of frontier health and quarantine. Methods According to the standardization practice of the lab of frontier health and quarantine, analyzed and summarized all kinds of standard ,request and literature on traceability of measurements. Results Traceability of measurements is a link process between the test results and legalize standards via a series of comparison measurements , it is a main means of lab standardization and quality assurance. But now, the state of traceability of measurements in the lab of frontier health and quarantine is in the initial stage. Due to the complexity of biological pattern, a small amount of test has an integrated reference system. In addition, the differential in routine testing process and the matrix effect make traceability of measurements more complex. Conclusion As a main means of quality assurance, traceability of measurements is being paid more attention to. According to the actual, the lab of frontie'r health and quarantine should set up a series of necessary reference system.
作者 蔡鹏
出处 《旅行医学科学》 2005年第3期37-40,共4页
关键词 实验室 量值溯源 参考系统 Lab Traceability of measurements Reference system
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  • 1European Union. Directive 98/79/EC of the european parliament and of the council of 27 october 1998 on in vitro diagnostic medical devices.Official Journal of the European Communities, 1998, L331 : 1-37. 被引量:1
  • 2International Organization for Standardization. In vitro diagnostic medical devices-measurement of quantities in samples of biological originmetrological traceability of values assigned to calibrators and control materials. ISO/DIS 17511, International Organization for Standardization,Geneva,2000. 被引量:1
  • 3International Organization for standardization. In vitro diagnostic medical devices-measurement of quantities in samples of biological originmetrological traceability of values for catalytic concentration of enzymes assigned to calibrators and control materials. ISO/DIS 18153,International Organization for Standardization, Geneva, 2000. 被引量:1
  • 4International Organization for Standardization. General requirements for the competence of testing and calibration laboratories. ISO/IEC 17025,International organization for standardization, Geneva, 1999. 被引量:1
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  • 6Siekmann L. Traceability of calibration for IVD industry: Process for eredentialing reference materials, reference methods and reference laboratories in europe. In: proceedings of the workshop on measurement traceability for clinical laboratory testing and in vitro diagnostic test systems. National Institute of Standards and Technology, Gaithersburg MD, 2000. 85-101. 被引量:1
  • 7Eckfeldt JH. History of reference systema in clinical measurements. In :proceedings of the workshop on measurement traceability for clinical laboratory testing and in vitro diagnostic test systems. National institute of standards and Technology: Gaithersburg MD, 2000. 161-172. 被引量:1

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