本欧洲标准规定了用于医疗目的或可能接触血液或体液的材料的小型蒸汽灭菌器和灭菌循环的性能要求和试验方法。本欧洲标准适用于使用电加热器产生蒸汽或使用灭菌器外部系统产生蒸汽的自动控制小型蒸汽灭菌器。本欧洲标准适用于小型蒸汽灭菌器，主要用于灭菌室容积小于60L、不能容纳灭菌模块（300 mm×300 mm×600 mm）的医疗器械。其他标准（如EN ISO 13485、EN ISO 14971）规定了有关质量管理和风险管理的要求。本欧洲标准不适用于用于液体或药品灭菌的小型蒸汽灭菌器。本欧洲标准未规定与使用灭菌器区域相关的风险（如易燃气体）的安全要求。本欧洲标准未规定湿热灭菌的验证和常规控制要求。注:EN ISO 17665-1中给出了湿热灭菌的验证和常规控制要求。该欧洲标准没有规定其他湿法工艺的要求，也采用湿热作为工艺的一部分（即甲醛、环氧乙烷）。

This European Standard specifies the performance requirements and test methods for small steam sterilizers and sterilization cycles which are used for medical purposes or for materials that are likely to come into contact with blood or body fluids. This European Standard applies to automatically controlled small steam sterilizers that generate steam using electrical heaters or use steam that is generated by a system external to the sterilizer. This European Standard applies to small steam sterilizers used primarily for the sterilization of medical devices with a chamber volume of less than 60 l and unable to accommodate a sterilization module (300 mm × 300 mm × 600 mm). The requirements concerning the quality management and risk management are addressed by other standards (e.g. EN ISO 13485, EN ISO 14971). This European Standard does not apply to small steam sterilizers that are used to sterilize liquids or pharmaceutical products. This European Standard does not specify safety requirements related to risks associated with the zone in which the sterilizer is used (e.g. flammable gases). This European Standard does not specify requirements for the validation and routine control of sterilization by moist heat. NOTE Requirements for the validation and routine control of sterilization by moist heat are given in EN ISO 17665-1. This European Standard does not specify requirements for other sterilization processes that also employ moist heat as part of the process (i.e. formaldehyde, ethylene oxide).