本欧洲标准规定了主要用于卫生保健的大型蒸汽灭菌器的要求和相关测试，用于灭菌一个或多个灭菌模块中包含的医疗设备及其附件。选择本欧洲标准中描述的试验载荷来代表大多数负载（即由金属，橡胶和多孔材料组成的包装物），用于评估医疗设备的通用蒸汽灭菌器。然而，特定负载（例如重金属物体或长和/或窄管腔）将需要使用其他测试负载。 本欧洲标准适用于设计用于容纳至少一个灭菌模块或具有至少60升的室容积的蒸汽灭菌器。 大型蒸汽灭菌器也可用于医疗器械的商业生产。 本欧洲标准没有规定要使用，含有或暴露于可能引起燃烧的易燃物质或物质的设备的要求。本欧洲标准没有规定用于处理生物废物或人体组织的设备的要求。 本欧洲标准没有描述控制灭菌器各个阶段的质量管理体系。 注1注意事项

This European Standard specifies requirements and the relevant tests for large steam sterilizers primarily used in health care for the sterilization of medical devices and their accessories contained in one or more sterilization modules. The test loads described in this European Standard are selected to represent the majority of loads (i.e. wrapped goods consisting of metal, rubber and porous materials) for the evaluation of general purpose steam sterilizers for medical devices. However, specific loads (e.g. heavy metal objects or long and/or narrow lumen) will require the use of other test loads. This European Standard applies to steam sterilizers designed to accommodate at least one sterilization module or having a chamber volume of at least 60 l. Large steam sterilizers can also be used during the commercial production of medical devices. This European Standard does not specify requirements for equipment intended to use, contain or be exposed to flammable substances or substances which could cause combustion. This European Standard does not specify requirements for equipment intended to process biological waste or human tissues. This European Standard does not describe a quality management system for the control of all stages of the manufacture of the sterilizer. NOTE 1 Attention is drawn to the standards for quality management systems e.g. EN ISO 13485. NOTE 2 Environmental aspects are addressed in Annex A.