GB/T 21415-2008
AbolishedIn vitro diagnostic medical devices - Measurement of quantities in biological samples - Metrological traceability of values assigned to calibrators and control materials
体外诊断医疗器械 生物样品中量的测量 校准品和控制物质赋值的计量学溯源性
Application Summary AI generated
This standard specifies the requirements for establishing and documenting the metrological traceability of values assigned to calibrators and control materials used in in vitro diagnostic (IVD) medical devices. It is applied by manufacturers of IVD products, such as clinical chemistry analyzers and immunoassay systems, to ensure that measurement results for biological samples (e.g., blood, urine) are traceable to higher-order reference standards, thereby supporting accuracy and comparability across different testing laboratories and healthcare settings.
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