中華人民共和國國家標準(中國大陸GB標準)英文版 |
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YY/T 1754.3-2023 医疗器械临床前动物研究 第3部分:用于评价补片组织学反应与生物力学性能的动物腹壁切口疝模型(中英文版) Preclinical Animal Studies of Medical Devices Part 3: Animal Model of Incisional Abdominal Hernia for Evaluation of Mesh Histological Response and Biomechanical Properties |
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YY/T 1874-2023 有源植入式医疗器械 电磁兼容 植入式心脏起搏器、植入式心律转复除颤器和心脏再同步器械的电磁兼容测试细则(中英文版) Active Implantable Medical Devices - Electromagnetic Compatibility - Electromagnetic Compatibility Test Rules for Implantable Cardiac Pacemakers, Implantable Cardioverter-Defibrillators and Cardiac Resynchronization Devices |
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YY 0970-2023 医疗保健产品灭菌 一次性使用动物源性医疗器械的液体化学灭菌剂 医疗器械灭菌过程的特征、开发、确认和常规控制的要求(中英文版) Sterilization of healthcare products - Liquid chemical sterilants for single-use medical devices of animal origin - Requirements for the characterization, development, validation and routine control of medical device sterilization processes |
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YY/T 0870.7-2023 医疗器械遗传毒性试验 第7部分:哺乳动物体内碱性彗星试验(中英文版) Genotoxicity Tests for Medical Devices - Part 7: Alkaline Comet Test in Mammals |
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YY/T 1473-2023 医疗器械标准化工作指南 涉及安全内容的标准制定(中英文版) Guidelines for Standardization of Medical Devices Standardization Involving Safety Content |
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YY/T 1842.7-2023 医疗器械 医用贮液容器输送系统用连接件 第7部分:血管内输液用连接件(中英文版) Medical devices - Connections for medical reservoir delivery systems - Part 7: Connections for intravascular infusion |
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YY/T 1907-2023 人工智能医疗器械 冠状动脉CT影像处理软件 算法性能测试方法(中英文版) Artificial Intelligence Medical Devices Coronary CT Image Processing Software Algorithm Performance Testing Methods |
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YY/T 0698.5—2023 最终灭菌医疗器械包装材料 第5部分:透气材料与塑料膜组成的可密封组合袋和卷材 要求和试验方法(中英文版) Packaging materials for terminally sterilized medical devices Part 5: Sealable combination bags and rolls composed of breathable materials and plastic films Requirements and test methods |
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YY/T 0466.1—2023 医疗器械 用于制造商提供信息的符号 第1部分:通用要求(中英文版) Medical devices Symbols for information provided by manufacturers Part 1: General requirements |
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YY/T 1914-2023 人类辅助生殖技术用医疗器械 器具类产品通用要求(中英文版) Medical devices for human assisted reproductive technology - General requirements for device products |
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YY/T 1912-2023 用于软组织再生医疗器械的生物学评价与试验(中英文版) Biological evaluation and testing of medical devices for soft tissue regeneration |
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YY/T 1842.3—2023 医疗器械 医用贮液容器输送系统用连接件 第3部分:胃肠道应用(中英文版) Medical devices - Connectors for medical liquid storage container delivery systems - Part 3: Gastrointestinal applications |
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WS/T 363.16—2023 卫生健康信息数据元目录 第16部分:药品与医疗器械(中英文版) Health Information Data Meta Catalog Part 16: Drugs and Medical Devices |
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WS/T 364.16—2023 卫生健康信息数据元值域代码 第16部分:药品与医疗器械(中英文版) Health information data element value field code Part 16: Drugs and medical devices |
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YY/T 1879-2022 医疗器械唯一标识的创建和赋予(中英文版) Creation and assignment of unique identifiers for medical devices |
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YY/T 1854-2022 聚氯乙烯医疗器械中偏苯三酸三辛酯(TOTM)溶出量测试方法(中英文版) Test method for dissolution of trioctyl trimellitate (TOTM) in polyvinyl chloride medical devices |
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YY/T 1833.3-2022 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(中英文版) Artificial Intelligence Medical Devices Quality Requirements and Evaluation Part 3: General Requirements for Data Labeling |
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YY/T 1842.6-2022 医疗器械 医用贮液容器输送系统用连接件 第6部分:神经应用(中英文版) Medical devices - Connections for medical reservoir delivery systems - Part 6: Neurological applications |
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YY/T 1852-2022 人类辅助生殖技术用医疗器械 培养用液中铵离子的测定(中英文版) Medical devices for human assisted reproductive technology Determination of ammonium ions in culture solution |
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YY/T 1833.2-2022 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(中英文版) Artificial Intelligence Medical Devices Quality Requirements and Evaluation Part 2: General Requirements for Datasets |
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