50.20 Proof sent to secretariat or FDIS ballot initiated: 8 weeks Aug 27, 2026
CEN
CEN/TC 102 Sterilizers and associated equipment for processing of medical devices
European Norm
11.080.10 Sterilizing equipment
Draft
1.1 This document specifies the requirements and the relevant tests for automatically controlled sterilizers employing ethylene oxide (EO) gas as the sterilant, either as a pure gas or a mixture with other gases (for example carbon dioxide or nitrogen) being used for the sterilization of medical devices and their accessories.
1.2 This document specifies requirements for ethylene oxide sterilizers (EO sterilizers) for:
— the performance and design of sterilizers intended to deliver a process capable of sterilizing medical devices;
— the equipment and controls of these sterilizers, needed for operation, control and monitoring of the sterilization processes;
— the test equipment and test procedures used to verify the sterilizer performance specified by this document.
1.3 This document does not cover sterilizers which employ the injection of EO or mixtures containing EO directly into packages or into a flexible chamber.
Legislation related to this standard
Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC
PUBLISHED
EN 1422:2014
IN_DEVELOPMENT
FprEN 1422
50.20
Proof sent to secretariat or FDIS ballot initiated: 8 weeks
Aug 27, 2026
