DIN Standards Committee Quality Management, Statistics and Certification
DIN 58948-7
Sterilization - Low temperature sterilizers - Part 7: Requirements for the installation and operation of ethylene oxide sterilizers and their supply sources
Sterilisation - Niedertemperatur-Sterilisatoren - Teil 7: Bauliche Anforderungen und Anforderungen an die Betriebsmittel sowie den Betrieb von Ethylenoxid-Sterilisatoren
Overview
The new edition of DIN EN 1422:2014 required the revision of DIN 58948-7. This standard specifies requirements for structural conditions, equipment and the operation of ethylene oxide sterilizers (EO sterilizers) in healthcare facilities. The requirements for the structural prerequisites as well as for the equipment (for example steam, water) include all information on the local conditions necessary for the installation of an EO sterilizer. As a prerequisite for the operation of EO sterilizers, requirements for personnel and commissioning as well as for the tests to be carried out have been defined. For requirements and test methods for ethylene oxide sterilizers, please refer to DIN EN 1422. The requirements for validation are specified in DIN EN ISO 11135-1. This standard is also suitable for demonstrating compliance with certain requirements of the 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).
