ISO 25424:2009规定了用于医疗器械的低温蒸汽和甲醛（LTSF）灭菌过程的开发，验证和常规控制的要求。 ISO 25424:2009旨在由流程开发商，灭菌设备制造商，要消毒的医疗器械制造商和负责消毒医疗器械的组织应用。 ISO 25424:2009涵盖使用低温蒸汽和甲醛混合物作为灭菌剂的灭菌方法，其工作仅低于环境压力

ISO 25424:2009 specifies requirements for the development, validation and routine control of a Low Temperature Steam and Formaldehyde (LTSF) sterilization process for medical devices. ISO 25424:2009 is intended to be applied by process developers, manufacturers of sterilization equipment, manufacturers of medical devices to be sterilized and the organizations with responsibility for sterilizing medical devices. ISO 25424:2009 covers sterilization processes that use a mixture of low temperature steam and formaldehyde as sterilant, and which are working below ambient pressure only.