DIN Standards Committee Quality Management, Statistics and Certification
DIN 58948-17
Sterilization - Low temperature sterilizers - Part 17: Requirements for the installation and operation of low temperature steam formaldehyde and formaldehyde sterilizers and their supply sources
Sterilisation - Niedertemperatur-Sterilisatoren - Teil 17: Bauliche Anforderungen und Anforderungen an die Betriebsmittel sowie den Betrieb von Niedertemperatur-Dampf-Formaldehyd-Sterilisatoren
Overview
The new edition of DIN EN 14180:2014 required the revision of DIN 58948-17. The standard specifies requirements for structural prerequisites for the operating equipment as well as for the operation of low temperature steam formaldehyde sterilizers (LTFS sterilizers) in healthcare facilities. The requirements for the structural conditions as well as for the operating equipment (for example steam, water) include all information on the local conditions that are necessary for the installation of an LTFS sterilizer. As a prerequisite for the operation of LTFS sterilizers requirements have been specified, among other things, for the personnel and for commissioning as well as for the tests to be performed. For requirements and test procedures for low temperature steam formaldehyde sterilizers, reference is made to DIN EN 14180. The requirements for validation are specified in DIN EN ISO 25424. The standard is also suitable for demonstrating compliance with certain requirements of the German Medical Devices Act (MPG). It is not applicable to the sterilization of liquids, pastes and powders. The standard has been prepared by Working Committee NA 063-04-02 AA "Niedertemperatur-Sterilisatoren" ("Low-temperature sterilizers") at DIN Standards Committee Medicine (NAMed).
