本文件规定了医疗机构医疗器械终端灭菌用灭菌器的通用要求。本文件涵盖在不同温度、高于、等于或低于大气压的密封容器内使用各种杀菌剂（单独或组合）的灭菌器。 本文件提供了一般性的高级要求和相应的测试方法。 本文件不提供工艺参数或灭菌周期参数的定量要求，或灭菌器性能测试、验证或常规控制的要求，因为这些取决于各自的灭菌方法。 本文件不取代或修改适用于灭菌器的已发布标准或其未来版本的要求或试验方法。 本文件不适用于: -使用辐射作为杀菌剂的灭菌器； -实验室设备消毒器； -用于准备培养基的消毒器； -用于实验室或其他废物生物去污的灭菌器，包括高风险类别病原体的去污； -用于房间生物去污的系统和隔离器系统； -用于就地灭菌的系统；或 -洗衣机消毒器。 注:虽然本文件规定了医疗应用中使用的灭菌器的要求，但仍有适用于工业应用的元素。

This document specifies the common requirements for sterilizers used for terminal sterilization of medical devices in health care facilities. This document covers sterilizers that operate with a variety of sterilizing agents (alone or in combination) within a sealed vessel at different temperatures, above, at, or below atmospheric pressure. This document provides high-level requirements and respective test methods that are general in nature. This document does not provide quantitative requirements for process parameters or parameters of the sterilization cycle, or requirements for performance testing, validation or routine control of sterilizers because these depend on the respective sterilization method. This document does not supersede or modify requirements or test methods of published standards applying to sterilizers, or future editions thereof. This document does not apply to: — sterilizers using radiation as the sterilizing agent; — sterilizers for laboratory equipment; — sterilizers used to prepare culture media; — sterilizers used for bio-decontamination of laboratory or other waste including decontamination of pathogens in a high risk category; — systems used for bio-decontamination of rooms and isolator systems; — systems used for sterilization in place; or — washer-disinfectors. NOTE Whilst this document provides requirements for sterilizers used in health care applications, there will be elements that are applicable to industrial applications.