BS EN ISO 18153-2003 体外诊疗装置.生物样品的定量测量.校准仪和控制系统指定酶的催化浓度的测量溯源性

标准号：BS EN ISO 18153-2003
中文标准名称：体外诊疗装置.生物样品的定量测量.校准仪和控制系统指定酶的催化浓度的测量溯源性
英文标准名称：In vitro diagnostic medical devices - Measurement of quantities in biological samples - Metrological traceability of values for catalytic concentration of enzymes assigned to calibrators and control materials
标准类型：C39
发布日期：2003/8/19 12:00:00
实施日期：2003/8/19 12:00:00
中国标准分类号：C39
国际标准分类号：07.100.10
适用范围：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.