ISO 17511:2003 玻璃诊断医疗设备-生物样品数量测量-口径测量器和原料控制对数值度量衡追踪

标准编号：ISO 17511:2003

中文名称：玻璃诊断医疗设备-生物样品数量测量-口径测量器和原料控制对数值度量衡追踪

英文名称：In vitro diagnostic medical devices — Measurement of quantities in biological samples — Metrological traceability of values assigned to calibrators and control materials

发布日期：2003-08

标准范围

ISO 17511:2003规定了如何确保分配给用于建立或验证测量真实性的校准器和控制材料的值的计量可追溯性。校准器和控制材料由制造商提供，作为体外诊断医疗设备的一部分，或与体外诊断医疗设备一起使用。外部质量评估（调查）样本，具有经证明的可交换性，其值通过国际商定的参考测量系统或国际商定的常规参考测量系统分配，属于ISO 17511:2003的范围。ISO 17511:2003不适用于没有指定值且仅用于评估测量程序精度（其重复性或再现性）的控制材料（精密控制材料）；用于实验室内质量控制目的的控制材料，其供应间隔为建议的可接受值，每个间隔由实验室间就一个规定的测量程序达成共识获得，且限值在计量上不可追溯；在同一计量水平上，两个测量程序的结果之间的相关性，旨在测量相同的数量，因为这种“水平”相关性不提供计量溯源性；校准源于不同计量水平下两个测量程序结果之间的相关性，但数量具有不同特征的分析物；常规结果到产品校准器的计量溯源性及其与任何医学鉴别极限的关系；以及涉及标称标度的性质，即。e、 不涉及数量级的（如血细胞鉴定）。

ISO 17511:2003 specifies how to assure the metrological traceability of values assigned to calibrators and control materials intended to establish or verify trueness of measurement. The calibrators and control materials are those provided by the manufacturers as part of, or to be used together with, in vitro diagnostic medical devices.External quality assessment (survey) samples, with proven commutability, whose values have been assigned by means of internationally agreed reference measurement systems or internationally agreed conventional reference measurement systems fall within the scope of ISO 17511:2003.ISO 17511:2003 is not applicable to control materials that do not have an assigned value and are used only for assessing the precision of a measurement procedure, either its repeatability or reproducibility (precision control materials); control materials intended for intralaboratory quality control purposes and supplied with intervals of suggested acceptable values, each interval obtained by interlaboratory consensus with respect to one specified measurement procedure, and with limiting values that are not metrologically traceable; correlation between results of two measurement procedures at the same metrological level, purporting to measure the same quantity, because such "horizontal" correlation does not provide metrological traceability; calibration derived from correlation between the results of two measurement procedures at different metrological levels, but with quantities having analytes of different characteristics; metrological traceability of routine results to the product calibrator and their relations to any medical discrimination limit; and properties involving nominal scales, i.e. where no magnitude is involved (e.g. identification of blood cells).

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