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  • BSI
    25/30508968 DC BS EN 1422 Sterilizers for medical purposes - Ethylene oxide sterilizers - Requirements and test methods
    Edition: 2025
    $78.16
    / user per year

Description of 25/30508968 DC 2025

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, 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.

Standard Number25/30508968 DC
TitleBS EN 1422 Sterilizers for medical purposes - Ethylene oxide sterilizers - Requirements and test methods
StatusDefinitive
Publication Date2025-04-24
Identical National Standard OfEN 1422
CommitteeCH/198
PublisherBSI
Pages118



About BSI

BSI Group, also known as the British Standards Institution is the national standards body of the United Kingdom. BSI produces technical standards on a wide range of products and services and also supplies certification and standards-related services to businesses.
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