保健产品灭菌.低温汽化过氧化氢.医疗器械灭菌过程的开发、验证和常规控制要求

[中文适用范围]： 适用于医疗设备低温过氧化氢蒸汽灭菌过程的研发、验证和常规控制的要求 不包括高温高压灭菌等其他灭菌方法 [外文原描述]： 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.