1.1？包含内容 1.1.1？本文件规定了使用汽化过氧化氢（VH2O2）作为灭菌剂的医疗器械低温灭菌过程的开发、验证和常规监控要求。 1.1.2？本文件适用于工艺开发人员、灭菌设备制造商、待灭菌医疗器械制造商、进行VH2O2灭菌工艺验证的组织以及负责灭菌医疗器械的组织。 注意VH2O2灭菌器可用于医疗和工业设施，本文件承认这两种应用之间的相似性和差异。 1.2？除外责任 1.2.1？本文件不涉及使用其他杀菌剂或过氧化氢溶液与其他化学品组合作为杀菌剂的工艺。 注意参见ISO14937，用于指导此类流程的验证。 1.2.2？本文件未规定海绵状脑病病原体灭活过程的开发、验证和常规控制要求，例如羊瘙痒、牛海绵状脑炎和克雅氏病。已在特定国家就处理可能受到这些制剂污染的材料提出了具体建议。 注意一些VH2O2灭菌器的工艺表明，海绵状脑病的病原体（例如羊瘙痒病、牛海绵状脑炎和克雅氏病）在一定程度上失活。然而，这种灭活是特定于过程、周期和测试协议的，因此这种灭活不在本文件的范围内，也没有提供具体的测试方法（更多信息请参见[14]、[26]和[30]）。 1.2.3？本文件未规定将医疗器械指定为无菌的要求。 注意例如，见EN 556–1或ANSI/AAMI ST67。 1.2.4？本文件未规定与VH2O2灭菌设备的设计和操作相关的职业安全要求。 注意有关安全的更多信息，请参阅参考书目中的示例。国家或地区法规也可能存在。 1.2.5？本文件不适用于所含产品的内容物，即灭菌过程任何阶段灭菌室内的环境都不会直接接触产品的产品，例如密封瓶中的溶液。 1.2.6？本文件不包括用于房间、外壳或环境空间的过氧化氢净化系统。 注意这些去污系统在环境条件下运行（例如温度和压力），通常使用与本文件中所述VH2O2灭菌过程不同的方法。

1.1  Inclusions 1.1.1    This document provides requirements for the development, validation and routine monitoring and control of a low temperature sterilization process for medical devices using vaporized hydrogen peroxide (VH2O2) as the sterilizing agent. 1.1.2    This document is intended to be applied by process developers, manufacturers of sterilization equipment, manufacturers of medical devices to be sterilized, organizations performing process validation of VH2O2 sterilization, and organizations responsible for sterilizing medical devices. NOTE      VH2O2 sterilizers can be used in both health care and industrial facilities, and this document acknowledges the similarities and differences between the two applications. 1.2  Exclusions 1.2.1    Processes that use other sterilizing agents, or hydrogen peroxide solution in combination with other chemicals as the sterilizing agent are not addressed in this document. NOTE      See ISO 14937 for guidance on validation of such processes. 1.2.2    This document does not specify requirements for development, validation and routine control of a process for inactivating the causative agents of spongiform encephalopathies, e.g. scrapie, bovine spongiform encephalopathy and Creutzfeldt-Jakob disease. Specific recommendations have been produced in particular countries for the processing of materials potentially contaminated with these agents. NOTE      Some VH2O2 sterilizers have processes that demonstrate some level of inactivation of the causative agents of spongiform encephalopathies, e.g. scrapie, bovine spongiform encephalopathy and Creutzfeldt-Jakob Disease. However, this inactivation is process, cycle, and test protocol specific, therefore this inactivation is outside the scope of this document, and no specific test methods are provided (see [14], [26], and [30] for more information). 1.2.3    This document does not specify requirements for designating a medical device as sterile. NOTE      See for example EN 556–1 or ANSI/AAMI ST67. 1.2.4    This document does not specify requirements for occupational safety associated with the design and operation of VH2O2 sterilization equipment. NOTE      For further information on safety, see examples in the Bibliography. National or regional regulations can also exist. 1.2.5    This document does not apply to the contents of contained product, i.e. product for which the environment within the sterilizer chamber during any stage of the sterilization process does not come into direct contact with the product, such as a solution in a sealed bottle. 1.2.6    This document does not cover hydrogen peroxide decontamination systems for use in rooms, enclosures or environmental spaces. NOTE      These decontamination systems operate at ambient conditions (e.g. temperature and pressure) and in general utilise an approach that is different to that of VH2O2 sterilization processes addressed in this document.