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ISO 15194:2002
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In vitro diagnostic medical devices — Measurement of quantities in samples of biological origin — Description of reference materials
体外诊断医疗器械.生物来源样品中数量的测量.标准物质的描述
ISO 15194:2002规定了标准物质描述的要求和格式。本标准适用于计量等级更高的标准物质,可分为一级测量标准和二级测量标准,可作为参考测量程序的校准器或控制材料。ISO 15194:2002不适用于作为体外诊断测量系统一部分的参考材料。
ISO 15194:2002还提供了有关如何收集赋值基本数据、如何显示赋值以及指定证书格式的说明。
ISO 15194:2002不适用于标准物质的生产。
ISO 15194:2002 specifies requirements and formats for the description of reference materials. It is applicable to reference materials of higher metrological order, classifiable as primary measurement standards and secondary measurement standards that function either as calibrators or control materials for reference measurement procedures. ISO 15194:2002 is not applicable to reference materials that are parts of an in vitro diagnostic measuring system.
ISO 15194:2002 also provides instructions on how to collect basic data for value assignment and how to present the assigned value as well as specifies the format for a certificate.
ISO 15194:2002 is not applicable to the production of the reference materials.