International standards in laboratory medicine.
International standards in laboratory medicine.
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检验医学的国际标准。
DOI：
10.1016/s0009-8981(01)00425-9
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发表时间：
2001
期刊：
影响因子：
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通讯作者：
A. Kallner
中科院分区：
文献类型：
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作者：
A. Kallner
国际标准在建立质量体系方面发挥着重要作用。ISO和CEN为医学实验室制定了相当多的标准。标准可以分层次地看待，但大多数标准是以类似的方式产生的，并由目标用户反复协商和审查。大多数标准是由行业和国家或国际组织提出的，而个人很少能影响内容。一个例外是一个会议，会议安排影响和改进建议的标准(国际标准化组织15196)在实验室医学质量规范。标准还可能影响分析工作中使用的试剂和试剂盒的方法实践和性能。一个很好的例子是关于校准器可追溯性的标准(国际标准化组织17511)，它说明了“测量不确定度”和“真实性”等概念的实际重要性。生物校准器，例如“世卫组织生物标准”，构成了一个特殊的问题，因为它们往往无法追溯到SI。应定义和参考参考程序。这将比参考只能追溯到母体制剂的参照物更有利。这将减少不确定度，并保证不同批次的校准器满足一定的计量标准。
International standards play an important role in establishing quality systems. A considerable number of standards have been created by ISO and CEN for medical laboratories. Standards can be looked upon in a hierarchal manner but most standards are produced in similarly with iterative consultations and review by the intended users. Most standards are suggested by industry and national or international organisations whereas individuals rarely can influence the contents. An exception is illustrated by a conference arranged to influence and improve the suggested standard (ISO 15196) on quality specifications in laboratory medicine. Standards may also influence the methodological practice and the performance of reagents and kits used in analytical work. A good example is the standard on traceability of calibrators (ISO 17511) that illustrates the practical importance of concepts like ‘uncertainty in measurements’ and ‘trueness’. Biological calibrators, e.g., ‘WHO biological standards’, constitute a special problem since they often cannot be traced to SI. A reference procedure should be defined and referred. This would be more advantageous than to refer to a reference material that can only be traced to a master preparation. This would reduce the uncertainty and guarantee that calibrators of different batches meet certain metrological criteria.