T/ZZB 2701-2022
Industrial ethvlene oxide sterilizer (English Version)
- Standard No.
- T/ZZB 2701-2022
- Language
- Chinese, Available in English version
- Release Date
- 2022
- Published By
- Group Standards of the People's Republic of China
- Latest
- T/ZZB 2701-2022
- Scope
- This document specifies the terms and definitions, classification and labeling, basic requirements, technical requirements, test methods, inspection rules, signs, instructions for use and packaging, transportation, storage, scrap treatment, and quality commitment of industrial ethylene oxide sterilizers. . This document applies to industrial ethylene oxide sterilizers (hereinafter referred to as sterilizers) whose maximum working pressure is less than 100 kPa and which use ethylene oxide liquefied gas for sterilization. The sterilizer has a volume of >1 m3 and is suitable for sterilization in the industrial production of medical devices. This document does not apply to ethylene oxide sterilizers with a sterilizer volume ≤ 1 m3 and used for sterilization of clinical medical devices. Note: Unless otherwise specified, the pressures mentioned in this standard are relative pressures. The content of this document includes the minimum performance and structural requirements for sterilizers to operate above or below atmospheric pressure: ——to ensure that the sterilization process can be used to sterilize sterilized items; ——to perform the sterilization process Equipment and controls necessary for implementation and monitoring. This document does not specify packaging materials for ethylene oxide sterilization. For relevant requirements, see GB 19633. This document does not specify sterilization materials. For relevant requirements on sterilization materials, please refer to standard YY/T 1267-2015. This document does not specify sterilization confirmation and routine control. For relevant requirements, please refer to GB 18279.1 and GB 18279.2. This document does not discuss the issue of ethylene oxide residues in medical devices. Note: National standards and industry standards stipulate that the ethylene oxide residual content of certain medical device products should be adopted.
T/ZZB 2701-2022 history
- 2022 T/ZZB 2701-2022 Industrial ethvlene oxide sterilizer
