发布时间：2024-05-27 17:49:26 - 更新时间：2024年06月29日 15:22
点击量：0
有样品要送检？试试一键送检，5分钟极速响应
在线提交检测需求
对接客服咨询检测
Medical device software. Process reference model of medical device software life cycle processes (IEC 62304)
Medical devices software. Part 1. Guidance on the application of ISO 14971 medical devices software
本部分为YY/T 0316-2016《医疗器械风险管理对医疗器械的应用》中包含的要求应用于有关YY/T 0664-2008《医疗器械软件软件生存周期过程》中所指的医疗器械软件提供了指南，本部分并不增加或改变YY/T 0316-2016或YY/T 0664-2008的要求。 当软件作为医疗器械／系统
Medical device software.Part 1:Guidance on the application of ISO 14971 to medical device software
"This technical report provides guidance for the application of the requirements contained in ISO 14971:2007@ Medical devices?? Application of risk
Medical device software - Part 1: Guidance on the application of ISO 14971 to medical device software
Medical device software — Part 1: Guidance on the application of ISO 14971 to medical device software
Medical device software - Part 1: Guidance on the application of ISO 14971 to medical device software
Medical device software - Part 3: Process reference model of medical device software life cycle processes (IEC 62304)
Medical device software — Part 3: Process reference model of medical device software life cycle processes (IEC 62304)
Medical device software - Part 2: Validation of software for medical device quality systems
Medical device software — Part 2: Validation of software for medical device quality systems
本标准适用于医疗器械软件的开发和维护。 当软件本身是医疗器械，或当软件是最终医疗器械的嵌入部分或组成部分时，本标准适用于该医疗器械软件的开发和维护。 本标准不覆盖医疗器械的确认和最终发行，即使当该医疗器械完全由软件组成时
Medical devices software.Software life cycle processes
Amendment 1 - Medical device software - Software life cycle processes
This standard defines the life cycle requirements for MEDICAL DEVICE SOFTWARE. The set of PROCESSES, ACTIVITIES, and TASKS described in this standard
Medical device software - Software life-cycle processes
Medical device software. Process reference model of medical device software life cycle processes (IEC 62304)
Medical devices software. Part 1. Guidance on the application of ISO 14971 medical devices software
本部分为YY/T 0316-2016《医疗器械风险管理对医疗器械的应用》中包含的要求应用于有关YY/T 0664-2008《医疗器械软件软件生存周期过程》中所指的医疗器械软件提供了指南，本部分并不增加或改变YY/T 0316-2016或YY/T 0664-2008的要求。 当软件作为医疗器械／系统
Medical device software.Part 1:Guidance on the application of ISO 14971 to medical device software
"This technical report provides guidance for the application of the requirements contained in ISO 14971:2007@ Medical devices?? Application of risk
Medical device software - Part 1: Guidance on the application of ISO 14971 to medical device software
Medical device software — Part 1: Guidance on the application of ISO 14971 to medical device software
Medical device software - Part 1: Guidance on the application of ISO 14971 to medical device software
Medical device software - Part 3: Process reference model of medical device software life cycle processes (IEC 62304)
Medical device software — Part 3: Process reference model of medical device software life cycle processes (IEC 62304)
Medical device software - Part 2: Validation of software for medical device quality systems
Medical device software — Part 2: Validation of software for medical device quality systems
本标准适用于医疗器械软件的开发和维护。 当软件本身是医疗器械，或当软件是最终医疗器械的嵌入部分或组成部分时，本标准适用于该医疗器械软件的开发和维护。 本标准不覆盖医疗器械的确认和最终发行，即使当该医疗器械完全由软件组成时
Medical devices software.Software life cycle processes
Amendment 1 - Medical device software - Software life cycle processes
This standard defines the life cycle requirements for MEDICAL DEVICE SOFTWARE. The set of PROCESSES, ACTIVITIES, and TASKS described in this standard
Medical device software - Software life-cycle processes
首页
点击咨询
