GB 18279-2023
Development, validation and routine control requirements for ethylene oxide medical device sterilization processes for healthcare product sterilization (English Version)

Standard No.
GB 18279-2023
Language
Chinese, Available in English version
Release Date
2023
Published By
General Administration of Quality Supervision, Inspection and Quarantine of the People‘s Republic of China
Latest
GB 18279-2023
Replace
GB 18279.1-2015 GB/T 18279.2-2015

GB 18279-2023 history

  • 2023 GB 18279-2023 Development, validation and routine control requirements for ethylene oxide medical device sterilization processes for healthcare product sterilization
  • 2015 GB 18279.1-2015 Sterilization of health care products.Ethylene oxide.Part 1:Requirements for development,validation and routine control of a sterilization process for medical devices
  • 2000 GB 18279-2000 Medical devices--Validation and routine control of ethylene oxide sterilization

GB 18279-2023 Development, validation and routine control requirements for ethylene oxide medical device sterilization processes for healthcare product sterilization has been changed from GB/T 18279.2-2015 Sterilization of health care products.Part 2:Guidance on the application of GB 18279.1.

Development, validation and routine control requirements for ethylene oxide medical device sterilization processes for healthcare product sterilization



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