YY 0503-2023 Active

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 (whether pure ethylene oxide gas or a mixture with other gases) as a sterilizing agent. Sterilizers can be used for sterilization in medical device production and in medical institutions. This document does not apply to the sterilization methods and equipment that directly inject ethylene oxide or mixtures containing ethylene oxide into packaging or flexible chambers. This document does not specify the pressure vessel requirements for sterilizers, nor does it specify the requirements for the treatment of waste gas, wastewater, and other waste generated during ethylene oxide sterilization, or the residual amount of ethylene oxide. Note: If the housing of the sterilizer meets the definition of a pressure vessel in special equipment, the sterilizer must meet the requirements of the corresponding regulations for pressure vessels.