ISO 25424 discusses the sterilization of health care products. ISO 25424 layouts requirements for the development, validation, and routine control of a low-temperature steam and formaldehyde (LTSF) sterilization process for medical devices using a mixture of low-temperature steam and formaldehyde as a sterilizing agent and which operates below ambient pressure.
ISO 25424 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.
Note: Although the scope of ISO 25424 is limited to medical devices, it specifies requirements and provides guidance that can be applied to other products and equipment.
ISO 25424 on sterilization of health care products is useful for:
A sterile medical device is one that is free of viable microorganisms. International Standards that specify requirements for validation and routine control of sterilization processes require, when it is necessary to supply a sterile medical device, that adventitious microbiological contamination of a medical device prior to sterilization be minimized.
ISO 25424 provides best practices guidelines on quality management system elements, sterilizing agent characterization, process characterization, equipment characterization, product definition, process definition, validation, product release from sterilization, maintaining process effectiveness, routine monitoring, and control for sterilization process for medical devices. This helps maintain the quality of medical devices and minimizes the risk of transmission of any infectious substance.
BS EN ISO 25424:2019 supersedes ISO 25424:2009, which has been withdrawn. BS EN ISO 25424:2019 has some technical changes with respect to ISO 25424:2009. These include:
EN ISO 25424
ISO 25424:2018