GB/T 44672-2024
ActiveIn vitro diagnostic medical devices—Requirements for international harmonisation protocols establishing metrological traceability of values assigned to calibrators and human samples
体外诊断医疗器械 建立校准品和人体样品赋值计量溯源性的国际一致化方案的要求
Application Summary AI generated
This standard specifies requirements for protocols that establish metrological traceability of values assigned to calibrators and human samples in in vitro diagnostic (IVD) medical devices, ensuring consistency across different measurement systems. It is applied by IVD manufacturers and clinical laboratories to harmonize test results internationally, particularly for assays like glucose or cardiac markers where accurate patient diagnosis and treatment depend on reliable, comparable measurements. The standard supports regulatory compliance and global interoperability of diagnostic data in healthcare settings.
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