本欧洲标准规定了使用环氧乙烷（EO）气体作为灭菌剂的自动控制灭菌器的要求和相关测试，作为纯气体或与其他气体的混合物，用于医疗器械及其附件的灭菌。 本欧洲标准规定了在超低压或大气压下工作的环氧乙烷灭菌器（EO灭菌器）的要求: - 灭菌器的性能和设计，确保过程能够消毒医疗器械; - 灭菌过程的验证和常规控制所需的这些灭菌器的设备和控制。 选择本欧洲标准中描述的测试负载来表示用于评估医疗设备的EO消毒器的性能的许多负载。但是，特定负载可能需要使用其他测试负载。 本欧洲标准没有规定确定加工产品无菌可能性所必需的那些试验，也没有规定在释放无菌产品之前所需的常规质量控制试验。这些主题在prEN ISO 11135:2012中得到解决。 本欧洲标准没有规定与设计相关的职业安全要求

This European Standard specifies the requirements and the relevant tests for automatically controlled sterilizers employing ethylene oxide (EO) gas as the sterilant, either as a pure gas or a mixture with other gases, being used for the sterilization of medical devices and their accessories. This European Standard specifies requirements for ethylene oxide sterilizers (EO-sterilizers) working at super or sub-atmospheric pressure for: - the performance and design of sterilizers to ensure that the process is capable of sterilizing medical devices; - the equipment and controls of these sterilizers necessary for the validation and routine control of the sterilization processes. The test loads described in this European Standard are selected to represent a number of loads for the evaluation of the performance of EO sterilizers for medical devices. However, specific loads may require the use of other test loads. This European Standard does not specify those tests which are necessary to determine the probability of a processed product being sterile, nor the routine quality control tests required prior to release of sterile product. These topics are addressed in prEN ISO 11135:2012. This European Standard does not specify requirements for occupational safety associated with the design and operation of EO sterilization facilities. NOTE 1 For further information on safety, see examples in the Bibliography. National or regional regulations can exist. This European Standard does not cover sterilizers which employ the injection of EO or mixtures containing EO directly into packages or into a flexible chamber. NOTE 2 See EN ISO 14937. This European Standard is not intended as a checklist for suitability of an existing EO sterilizer when assessing compliance with prEN ISO 11135:2012. This standard is not intended to be applied retrospectively. This European Standard does not cover analytical methods for determining levels of residual EO and/or its reaction products. NOTE 3 For further information see ISO 10993 7.