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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: | valid |
| Superseded by: | |
| Superseded on: | |
| Abolished on: | |
| Superseding: | |
| Word Count: | 21500 words |
| Similar Standards: | T/CSBME 009-2019 T/CSBME 064-2022 T/CSBME 017-2020 GB/T 35533-2017 T/GDMDMA 0012.14-2022 GB 7954-1987 T/CSBME 026-2021 DB32/T 4271-2022 T/CQAP 2002-2022 T/CSBME 006-2019 T/CSBME 027-2021 T/CSBME 031-2021 T/CSBME 018-2020 YY 9706.278-2023 GB/T 44585.1-2024 YY/T 1833.5-2024 YY/T 1950-2024 YY/T 1940-2024 MZ/T 238-2025 GB/T 44827-2024 |
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