GB/T 19702-2021
ActiveIn vitro diagnostic medical devices—Measurement of quantities in samples of biological origin—Requirements for content and presentation of reference measurement procedures
体外诊断医疗器械 生物源性样品中量的测量 参考测量程序的表述和内容的要求
Application Summary AI generated
This standard specifies the requirements for the content and presentation of reference measurement procedures used in in vitro diagnostic (IVD) medical devices. It is applied in clinical laboratories and by IVD manufacturers to ensure the accuracy, traceability, and comparability of measurements of quantities in biological samples, such as blood or urine. The standard supports the calibration and validation of diagnostic tests, particularly in contexts requiring high metrological reliability, like disease diagnosis or monitoring.
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