Standard Number: YY 0503-2023(YY0503-2023)
Chinese:环氧乙烷灭菌器
English:Ethylene oxide sterilizer
Effective Date:2025-07-01
ICS:11.080.10
Standard Applicability:This document specifies the classification and requirements of ethylene oxide sterilizers (hereinafter referred to as sterilizers) and describes the corresponding test methods. This document applies to automatically controlled sterilizers that use ethylene oxide gas (either pure ethylene oxide gas or mixtures with other gases) as the sterilizing agent. The sterilizers can be used for production sterilization in the medical device industry and sterilization in medical institutions. This document does not apply to sterilization methods and equipment in which ethylene oxide or mixtures containing ethylene oxide are injected directly into packages or flexible cavities. This document does not stipulate the pressure vessel requirements of the sterilizer, nor does it stipulate the waste disposal requirements of waste gas and waste water generated in the sterilization of ethylene oxide and the residual amount of ethylene oxide.
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