YY 0503-2016 Ethylene oxide sterilizer

Scope

This standard specifies the terms and definitions, classification and marking, requirements, test methods, inspection rules, marking, user manuals, and packaging, transportation, and storage of ethylene oxide sterilizers. This standard applies to 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. These sterilizers are used for industrial production sterilization and medical sterilization. Note: Unless otherwise specified, the pressures referred to in this standard are all relative pressures. The content of this standard 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; - Equipment and control devices necessary for implementing and monitoring the sterilization process. This standard does not specify the packaging requirements for finally sterilized medical devices. For related requirements, please refer to GB/T 19633. This standard does not specify whether medical device materials are suitable for ethylene oxide sterilization. For related requirements, please refer to YY/T 1267. This standard does not specify requirements for sterilization validation and routine control. For related requirements, please refer to GB 18279. This standard does not discuss the residual amount of ethylene oxide in medical devices. Note: For certain medical device products, the national and industry standards specify the allowable residual amount of ethylene oxide, and these requirements should be followed accordingly.

Development Information

Replace the following standards

Superseded by the following standards

Referenced Standards

Related Standards