ÖNORM EN ISO 25424

This document specifies 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 sterilizing agent and which operates below ambient pressure. This document 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 (see ISO 14937:2009, Table E.1). This document does not specify requirements for the development, validation and routine control of a process for inactivating the causative agents of spongiform encephalopathies such as 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. This document does not specify requirements for designating a medical device as “STERILE”. Such requirements are given in EN 556-1. This document does not specify a quality management system for the control of all stages of production of medical devices. This document does not specify requirements for occupational safety associated with the design and operation of LTSF sterilization facilities. This document does not cover analytical methods for determining levels or residues of formaldehyde and/or its reaction products. This document does not cover preparatory measures that might be necessary before sterilization such as cleaning, disinfection and packing.