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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| Superseded by: | |
| Superseded on: | |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: | DB2301/T 91-2021 FZ/T 50043-2018 Q/SY 1124.7-2008 T/CEC 752-2023 GB 14622-2026 GB 4569-2026 GB 18280.1-2025 GB 11417.2-2025 GB 11417.3-2025 YY 0781-2025 GB 15811-2025 GB 23101.2-2025 YY 0300-2025 YY 0621-2025 YY 0710-2025 YY 0780-2025 YY 0948-2025 YY 0989.6-2025 GB 24788-2025 GB 42125.11-2025 |
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