关键词: 疫苗冰箱, 世界卫生组织, 性能质量安全, 设备监控系统, 数据记录仪, 机器接口

Abstract: Recently, the World Health Organization has proposed for the first time in its vaccine refrigerator series standards the requirement for an Vaccine Cold Chain Equipment Monitoring System (EMS), with the aim of achieving standardization and interoperability of vaccine cold chain equipment data collection to support national EPI programs. The EMS monitoring system requirements proposed by WHO indicate that WHO’s control of the vaccine cold chain will adopt intelligent means towards data electronification, remote monitoring, and system integration. The WHO standards are not only applied in WHO projects, but also highly recognized in some countries and regions in Africa and Southeast Asia. They are one of the standards that are widely used in the export of vaccine refrigerators in China. This standard upgrade involves the upgrading of product hardware and software, which has a significant impact on enterprises. In order to facilitate relevant personnel to quickly familiarize themselves with and understand the standards, the WHO vaccine refrigerator EMS requirements were analyzed through literature analysis and standard interpretation methods. The WHO vaccine cold chain related standards and requirements required to achieve EMS requirements were sorted and summarized using comparative analysis methods. Examples were given to illustrate their verification methods, experimental equipment requirements, and issues to be noted in the experiments, providing reference for vaccine refrigerator enterprises to complete product development and pass verification smoothly. We also hope to provide reference for China to achieve full chain supervision of vaccine cold chain and improve the vaccine cold chain standard system for long-term development through the research of WHO vaccine cold chain series standards.

Key words: Vaccine refrigerator, World Health Organization(WHO), Performance,quality and safety(PQS), Equipment monitoring systems(EMS), Data logger, mMachine-to-machine interface