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| Chinese National Standard Category: Medical apparatus and devices in general |
| English Title: | Application of risk management for medical device connecting IT-network—Part 1：Safety, effectiveness and security in the implementation and use of connected medical devices or connected health software |
| Chinese Title: | 风险管理在接入IT网络的医疗器械中的应用 第1部分：联网医疗器械或健康软件在其实施和使用中的安全、有效性和网络安全 |
| Standard No.: | GB/T 44585.1-2024 |
| Category No.: | C30 |
| Issued by: | SAMR, SAC |
| Issued on: | 2024-09-29 |
| Implemented on: | 2026-4-1 |
| Status: | to be valid |
| Superseded by: | |
| Superseded on: | |
| Abolished on: | |
| Superseding: | |
| Word Count: | 21500 words |
| Similar Standards: | T/ZGKSL 012-2023 T/ZGKSL 017-2023 GB/T 46660-2025 GB/T 16886.17-2025 T/ZTCA 018-2024 T/GDMDMA 0012.1-2022 T/GDMDMA 0012.2-2021 T/GDMDMA 0012.5-2022 T/GDMDMA 0012.6-2022 T/GDMDMA 0012.7-2022 T/GDMDMA 0012.8-2022 T/GDMDMA 0012.9-2022 T/GDMDMA 0023-2022 T/GDMDMA 0012.11-2022 YY/T 1960-2025 DB3710/T 237-2024 T/SZZX 016-2023 T/SZZX 017-2024 T/SZZX 014-2023 DB12/T 3045-2025 |
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