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Chinese National Standard Category: Public medical equipment

English Title: Sterilization of health-care products—Ethylene oxide—Requirements for the development,validation and routine control of a sterilization process for medical devices
Chinese Title: 医疗保健产品灭菌 环氧乙烷 医疗器械灭菌过程的开发、确认和常规控制要求
Standard No.: GB 18279-2023
Category No.: C47
Issued by: SAMR; SAC
Issued on: 2023-09-08
Implemented on: 2026-10-1
Status: to be valid
Superseded by:
Superseded on:
Abolished on:
Superseding: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
GB/T 18279.2-2015 Sterilization of health care products―Part 2:Guidance on the application of GB 18279.1
Word Count:40000 words
Similar Standards: T/GIEHA 025-2021   GB 2638-1981   T/GIEHA 019-2020   T/GIEHA 018-2020   T/GIEHA 034-2022   T/CSBME 023-2020   GB/Z 18029.28-2021   T/CSBME 022-2020   GB 8599-2023   GB 18279-2023   WS/T 835-2024   GB/T 19973.1-2023   YY/T 1268-2023   YY/T 0567.6-2022   YY/T 1464-2022   YY/T 1733-2020   YY/T 0567.2-2021   YY/T 0802-2020   YY/T 1737-2020   T/CIQA 17-2021  
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