本标准涵盖了医疗设施中一般用途环氧乙烷灭菌器的最低标签、安全、性能和测试要求，以及具有自动控制功能的环氧乙烷灭菌器。它还包括环氧乙烷灭菌剂源的标签、产品组成和容器要求，以及环氧乙烷排放控制系统的标签、性能、安全和安装要求。

This standard covers minimum labeling, safety, performance, and testing requirements for ethylene oxide sterilizers that are intended for general-purpose use in health care facilities and that have automatic controls. It also covers labeling, product composition, and container requirements for ethylene oxide sterilant sources, as well as labeling, performance, safety, and installation requirements for ethylene oxide emission control systems.