为了贯彻落实《中华人民共和国生物安全法》对病原微生物实验室的生物安全管理要求，国家卫生健康委员会修订并发布了卫生行业标准WS/T 442-2024《临床实验室生物安全指南》。该卫生行业标准规定了医疗机构临床实验室生物安全风险管理、设施设备和实验活动管理等的基本要求，是临床生物安全二级实验室的建设依据和生物安全管理体系运行的准则。本文就该行业标准修订背景、编写情况、主要内容和要点难点等进行解读和分析，以帮助各级医疗机构更充分地理解和执行该标准的相关规定，促进临床实验室生物安全管理规范化、降低职业暴露风险、提升公共卫生应急响应能力，为新发突发传染病防控提供安全保障。

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.