ISO 18153:2003 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酶接触反应浓度值度量衡追踪

标准编号：ISO 18153:2003

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酶接触反应浓度值度量衡追踪

英文名称：In vitro diagnostic medical devices — Measurement of quantities in biological samples — Metrological traceability of values for catalytic concentration of enzymes assigned calibrators and control mate

发布日期：2003-08

标准范围

ISO 18153:2003规定了如何确保分配给校准器和控制材料的值的计量可追溯性，以建立或验证酶催化浓度测量的真实性。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。以下主题不在ISO 18153:2003的范围内:参考测量程序的设计或选择要求；涉及酶质量或酶免疫反应性的数量；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（精度控制材料）；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；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；涉及名词和序数标度的性质。

ISO 18153:2003 specifies how to assure the metrological traceability of values assigned to calibrators and control materials intended to establish or verify trueness of measurement of the catalytic concentration of enzymes.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.The following subjects are outside the scope of ISO 18153:2003: requirements for the design or selection of a reference measurement procedure; quantities involving mass of enzyme or immunoreactivity of enzymes; 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; metrological traceability of routine results to the product calibrator and their relations to any medical discrimination limit; properties involving nominal and ordinal scales.

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