China National Standards

China Medical Device Software Industry Standards English PDF List


  •  China "Medical Device Software" Industry Standards English PDF List:
  • Standard  Code Standard Title Standard Class Order
    YY/T 1907-2023 Artificial Intelligence Medical Devices Coronary CT Image Processing Software Algorithm Performance Testing Methods {译}
    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
    China Pharmaceutics Industry Standards
    Medical Device Software

    English PDF
    YY/T 0664—2020 Medical Device Software Software Lifecycle Process {译}
    医疗器械软件 软件生存周期过程
    China Pharmaceutics Industry Standards
    Medical Device Software

    English PDF
    YY/T 1406.1-2016 Medical Device Software—Part 1:Guidance on the application of YY/T 0316 to medical device software
    医疗器械软件 第1部分:YY/T0316应用于医疗器械软件的指南
    China YY-Medicine & Medical Device Industry Standards
    Medical Device Software

    English PDF
    YY/T 0664-2008 Medical Device Software. Software life cycle processes
    医疗器械软件 软件生存周期过程
    China Medicine & Medical Device Standards
    Medical Device Software

    English PDF

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