China Youth Daily, Beijing, December 28 (China Youth Daily, China Youth Network reporter Li Ruoyi) The reporter learned from the State Administration for Market Regulation today that recently, the State Administration for Market Regulation (National Standards Committee) issued the "Application of Risk Management in Medical Laboratories" (GB T 43278-2023) and "Guidelines for the Evaluation of Measurement Uncertainty in Medical Laboratories" (GB Z 43280-2023) Two national standards, which are "Requirements for the Quality and Capability of Medical Laboratories" GB T An important supporting document for the 22576 series of standards.
According to reports, "The Application of Risk Management in Medical Laboratories" describes the requirements for laboratory design and development and risk management in the whole process before, during and after testing, aiming to help medical laboratories integrate risk management into their daily organization, operation and management, and provide practical risk management guidance and guarantee for the quality management and technical capabilities of medical laboratories.
Medical Laboratory Guidelines for Measurement Uncertainty Estimation provide guidelines for the assessment and expression of measurement uncertainty (MU) of medical laboratory measurements. The release of this standard will provide detailed guidance for medical laboratories to carry out uncertainty measurement, and also urge China's in vitro diagnostic equipment manufacturers to pay full attention to the traceability and uncertainty evaluation in the research and development stage, so as to jointly promote the scientific and standardized development of the industry.
The relevant person in charge of the State Administration for Market Regulation said that the two new standards are equivalent to the use of international standards, and the release and implementation of the standards will help China's industry users quickly follow up the international development trend, further improve the scientificity and reliability of China's laboratory test results, promote the improvement of China's medical laboratories and in vitro diagnostic industry, and help the implementation of relevant policies such as the "Healthy China Action", so as to benefit the lives and health of the people.
*: China Youth Daily client.