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| Chinese National Standard Category: |
| English Title: | Sterilization of health care products—Radiation—Part 1: Requirements for the development,validation and routine control of a sterilization process for medical devices |
| Chinese Title: | 医疗产品灭菌 辐射 第1部分：医疗器械灭菌过程的开发、确认和常规控制要求 |
| Standard No.: | GB 18280.1-2025 |
| Category No.: | |
| Issued by: | SAMR;SAC |
| Issued on: | 2025-12-02 |
| Implemented on: | 2029-1-1 |
| Status: | to be valid |
| Superseded by: | |
| Superseded on: | |
| Abolished on: | |
| Superseding: | GB 18280.1-2015 Sterilization of health care products―Radiation―Part 1:Requirements for development,validation and routine control of a sterilization process for medical devices |
| Word Count: | 15500 words |
| Similar Standards: | SY/T 7614-2025E JTG/T 3302-2025 GB 4482-1984 GB/T 4074.28-4074.31-1983 GB/T 4074.23-1983 GB/T 4074.16-1983 GB/T 6411-1986 DB34/T 2391-2015 DB34/T 992-2009 DB34/T 1021-2009 DB43/T 1503-2018 DB43/T 1536-2018 DB43/T 2313-2022 DB42/T 1921.5-2022 DB43/T 601-2010 DB43/T 1759-2020 DB43/T 876.4-2014 DB43/T 876.5-2014 DB13/T 3031—2022 DB35/T 1137-2011 |
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