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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| Superseded by: | |
| Superseded on: | |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: |
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