To implement the biosafety management requirements for clinical laboratories as stipulated in the Biosafety Law of the People's Republic of China, the National Health Commission revised and released the health industry standard WS/T 442-2024 "Guideline for clinical laboratory biosafety". This guideline outlines the basic requirements for biosafety risk management, facilities and equipment, and experimental activities in clinical laboratories of medical institutions. It serves as the basis for the construction of level 2 clinical biosafety laboratories and as a guideline for biosafety management. This article provides an interpretation and analysis of the background, development process, main content, and key points of the guideline, with the aim of helping various levels of medical institutions better understand and implement the relevant provisions of the standard, so as to promote the standardization of biological safety management in clinical laboratories, reduce occupational exposure risks, improve public health response capabilities, and provide safety assurance for the prevention and control of emerging infectious diseases.