Sterilization of medical devices - Low temperature steam and formaldehyde - Requirements for development, validation and routine control of a sterilization process for medical devices
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.