T/ZZB 2701-2022 Industrial ethylene oxide sterilizer

Scope

Main technical content: This document specifies the terms and definitions, classification and marking, basic requirements, technical requirements, test methods, inspection rules, marking, user manuals and packaging, transportation, storage, and disposal of industrial ethylene oxide sterilizers. This document applies to industrial ethylene oxide sterilizers (hereinafter referred to as sterilizers) that use ethylene oxide liquefied gas for sterilization and have a maximum working pressure of less than 100 kPa. The sterilizer has a volume of more than 1 m3 and is suitable for sterilization in the medical device industry. This document does not apply to ethylene oxide sterilizers with a volume of ≤1 m3 used for sterilizing medical devices in clinical settings. Note: Unless otherwise specified, all pressures referred to in this standard are relative pressures. The content of this document includes minimum performance and structural requirements for operating the sterilizer above or below atmospheric pressure: - Ensuring that the sterilization process can be used to sterilize the items to be sterilized; - The necessary equipment and control devices for implementing and monitoring the sterilization process. This document does not specify the packaging materials for ethylene oxide sterilization. For related requirements, please refer to GB 19633. This document does not specify the sterilization materials. For related requirements of the sterilization materials, please refer to the standard YY/T 1267-2015. This document does not specify the sterilization confirmation and routine control. For related requirements, please refer to GB 18279.1 and GB 18279.2. This document does not discuss the residual amount of ethylene oxide in medical devices. Note: National and industry standards specify the residual amount of ethylene oxide for certain medical device products, and these requirements should be adopted accordingly.

Development Information

Related Standards