GB/T 19703-2020
ActiveIn vitro diagnostic medical devices—Measurement of quantities in samples of biological origin—Requirements for certified reference materials and the content of supporting documentation
体外诊断医疗器械 生物源性样品中量的测量 有证参考物质及支持文件内容的要求
Application Summary AI generated
This standard specifies the requirements for certified reference materials used in in vitro diagnostic medical devices, ensuring their traceability and suitability for calibrating measurement procedures. It is applied in clinical laboratories and by medical device manufacturers to validate the accuracy of diagnostic tests performed on biological samples such as blood or urine. The standard also defines the content of supporting documentation, enabling consistent quality control and regulatory compliance across healthcare testing environments.
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Transparency note: The application summary and key sentences on this page were automatically generated by AI from the standard's original text. This content has not been human-verified and should not be used for compliance or regulatory purposes. Always refer to the official standard document from the issuing authority.