DIN Standards Committee Health Technologies
Sterilizers for medical purposes - Ethylene oxide sterilizers - Requirements and test methods
Abstract
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.
Begin
2023-06-08
WI
00102181
Planned document number
FprEN 1422
Responsible national committee
NA 176-03-04 AA - Low temperature sterilizers
Responsible european committee
CEN/TC 102/WG 6 - Low temperature sterilizers
draft standard
Sterilizers for medical purposes - Ethylene oxide sterilizers - Requirements and test methods
2025-04
Order from DIN Media
previous edition(s)
Sterilizers for medical purposes - Ethylene oxide sterilizers - Requirements and test methods
2014-05
