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| Standard Code | Standard Title | Standard Class | Order |
|---|---|---|---|
| YY/T 1833.4-2023 |
Artificial Intelligence Medical Devices Quality Requirements and Evaluation Part 4: Traceability {译} 人工智能医疗器械 质量要求和评价 第4部分：可追溯性 |
China Pharmaceutics Industry
Standards medical device quality |
 English PDF |
| YY/T 0468-2015 |
medical device quality management medical device terminology system data structure {译} 医疗器械 质量管理 医疗器械术语系统数据结构 |
China Pharmaceutics Industry
Standards medical device quality |
English PDF |
| YY/T 1833.3-2022 |
Artificial Intelligence Medical Devices Quality Requirements and Evaluation Part 3: General Requirements for Data Labeling {译} 人工智能医疗器械 质量要求和评价 第3部分：数据标注通用要求 |
China Pharmaceutics Industry
Standards medical device quality |
English PDF |
| YY/T 1833.2-2022 |
Artificial Intelligence Medical Devices Quality Requirements and Evaluation Part 2: General Requirements for Datasets {译} 人工智能医疗器械 质量要求和评价 第2部分：数据集通用要求 |
China Pharmaceutics Industry
Standards medical device quality |
English PDF |
| YY/T 1833.1-2022 |
Artificial intelligence medical devices - Quality requirements and evaluation - Part 1: Terminology {译} 人工智能医疗器械 质量要求和评价 第1部分：术语 |
China Pharmaceutics Industry
Standards medical device quality |
English PDF |
| YY/T 0595-2020 |
medical device quality Management System YY/T 0287-2017 Application Guide {译} 医疗器械 质量管理体系YY/T 0287-2017 应用指南 |
China Pharmaceutics Industry
Standards medical device quality |
English PDF |
| YY/T 0468-2015 |
Medical devices. Quality management. Medical device nomenclature data structure 医疗器械 质量管理 医疗器械术语系统数据结构 |
China Medicine & Medical Device
Standards medical device quality |
English PDF |
| YY/T 0595-2006 |
Medical devices. Quality management systems. Guidance on the application of YY/T0287-2003 医疗器械 质量管理体系 yy/t 0287-2003 应用指南 |
China Medicine & Medical Device
Standards medical device quality |
English PDF |
| YY/T 0287-2003 |
Medical devices. Quality management systems. Requirements for regulatory purposes 医疗器械 质量管理体系 用于法规的要求 |
China Medicine & Medical Device
Standards medical device quality |
English PDF |
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