BS EN ISO 25424:2018+A1:2022 PDF

Scope: 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. provides guidance that can be applicable to other products and equipment. equipment, manufacturers of medical devices to be sterilized and the organizations with responsibility for sterilizing medical devices (see ISO 14937:2009, Table E.1). 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. Such requirements are given in EN 556‑1. production of medical devices. manufacture or reprocessing, but those elements of such a system that are required are normatively referenced at appropriate places in the text. Attention is drawn to the standards for quality management systems (see process. Further guidance is given in E.4 of ISO 14937:2009. and operation of LTSF sterilization facilities. requirements. the preparatory measures (see ISO 17664).

BS EN ISO 25424:2018+A1:2022 history

2022 BS EN ISO 25424:2019+A1:2022 Sterilization of health care products. Low temperature steam and formaldehyde. Requirements for development, validation and routine control of a sterilization process for medical devices
1970 BS EN ISO 25424:2019 Sterilization of medical devices. Low temperature steam and formaldehyde. Requirements for development, validation and routine control of a sterilization process for medical devices
2011 BS EN ISO 25424:2011 Sterilization of medical devices. Low temperature steam and formaldehyde. Requirements for development, validation and routine control of a sterilization process for medical devices
2007 BS EN 15424:2007 Sterilization of medical devices. Low temperature steam and formaldehyde. Requirements for development, validation and routine control of a sterilization process for medical devices