DIN EN ISO 25424:2011-09

This International Standard has been originally prepared as a European Standard under the designation EN 15424 by Technical Committee CEN/TC 204 "Sterilization of medical devices" (secretariat: BSI, United Kingdom) and was published in 2007. In 2009, the European Standard was adopted without any modifications as ISO 25424 by ISO/TC 198 "Sterilization of health care products". For unification of the numbering, CEN/TC 204 decided to retroactively adopt the ISO standard as EN ISO 25424 without any amendments and as a replacement for EN 15424. This International Standard applies to sterilization processes which use a mixture of low-temperature steam and formaldehyde as sterilant, and which use a pressure below ambient pressure. It specifies the requirements which shall be considered for the development, validation and routine control of the elements, such as: - sterilant characterization - process and equipment characterization - product and process definition - validation (consisting of installation, operational and performance qualification) - product release from sterilization - routine monitoring and maintaining process effectiveness For microbiological performance qualification, the standard contains three normative methods. The normative part is supplemented by informative annexes (guidance on application of this standard and overview over the environmental aspects covered). Other informative annexes contain the comparison of clauses of the standard with the essential requirements of EU Directive 93/42/EEC concerning medical devices, EU Directive 90/385/EEC relating to active implantable medical devices and EU Directive 98/79/EEC on in-vitro diagnostic medical devices. At DIN, Working Committee NA 063-04-02 AA "Niedertemperatur-Sterilisatoren" ("Low-temperature sterilizers") at NAMed has been involved in the preparation of the standard.