发布时间：2024-05-27 17:49:26 - 更新时间：2024年06月29日 15:22
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General requirements of disinfectant of medical instruments
本标准适用于对体外诊断医疗器械(以下简称IVD MD)的性能评估，包括自我检测体外诊断医疗器械，进行性能评估。 本标准规定了制造商在性能评估研究中对研究计划、实施、评估和制定文件的职责和总体要求。 本标准不适用于对某一特定IVD MD或某一具体用途的评估方案。 考虑到IVD MD的性质和用途
General requirements of performance evaluation of in vitro diagnostic medical devices
Medical devices. Recognized essential principles of safety and performance of medical devices. General essential principles and additional specific essential principles for all non-IVD medical devices and guidance on the selection of standards
Medical devices - Recognized essential principles of safety and performance of medical devices - Part 1: General essential principles and additional specific essential principles for all non-IVD medical devices and guidance on the selection of standards
Medical devices—Application of risk management to medical devices
Medical devices. Application of usability engineering to medical devices
Medical devices. Application of usability engineering to medical devices
Medical devices. Application of usability engineering to medical devices
本标准为制造商规定了一个过程，以识别与医疗器械[包括体外诊断(IVD)医疗器械]有关的危险(源)，估计和评价相关的风险，控制这些风险，并监视控制的有效性。本标准的要求适用于医疗器械生命周期的所有阶段。本标准不用于临床决策。本标准不规定可接受的风险水平。本标准不要求制造商有一个适当的质量体系。然而
Medical devices.Application of risk management to medical devices
Medical devices. Application of risk management to medical devices
Medical devices - Application of usability engineering to medical devices
本标准为制造商规定了一个过程，以判定与医疗器械，包括体外诊断（IVD）医疗器械有关的危害，估计和评价相关的风险，控制这些风险，并监视控制的有效性。 本标准的要求适用于医疗器械生命周期的所有阶段。 本标准不用于临床决策。 本标准不规定可接受的风险水平。 本标准不要求制造商有一个适当的质量体系
Medical devices.Application of risk management to medical devices
Medical devices — Application of risk management to medical devices
General requirements of disinfectant of medical instruments
本标准适用于对体外诊断医疗器械(以下简称IVD MD)的性能评估，包括自我检测体外诊断医疗器械，进行性能评估。 本标准规定了制造商在性能评估研究中对研究计划、实施、评估和制定文件的职责和总体要求。 本标准不适用于对某一特定IVD MD或某一具体用途的评估方案。 考虑到IVD MD的性质和用途
General requirements of performance evaluation of in vitro diagnostic medical devices
Medical devices. Recognized essential principles of safety and performance of medical devices. General essential principles and additional specific essential principles for all non-IVD medical devices and guidance on the selection of standards
Medical devices - Recognized essential principles of safety and performance of medical devices - Part 1: General essential principles and additional specific essential principles for all non-IVD medical devices and guidance on the selection of standards
Medical devices—Application of risk management to medical devices
Medical devices. Application of usability engineering to medical devices
Medical devices. Application of usability engineering to medical devices
Medical devices. Application of usability engineering to medical devices
本标准为制造商规定了一个过程，以识别与医疗器械[包括体外诊断(IVD)医疗器械]有关的危险(源)，估计和评价相关的风险，控制这些风险，并监视控制的有效性。本标准的要求适用于医疗器械生命周期的所有阶段。本标准不用于临床决策。本标准不规定可接受的风险水平。本标准不要求制造商有一个适当的质量体系。然而
Medical devices.Application of risk management to medical devices
Medical devices. Application of risk management to medical devices
Medical devices - Application of usability engineering to medical devices
本标准为制造商规定了一个过程，以判定与医疗器械，包括体外诊断（IVD）医疗器械有关的危害，估计和评价相关的风险，控制这些风险，并监视控制的有效性。 本标准的要求适用于医疗器械生命周期的所有阶段。 本标准不用于临床决策。 本标准不规定可接受的风险水平。 本标准不要求制造商有一个适当的质量体系
Medical devices.Application of risk management to medical devices
Medical devices — Application of risk management to medical devices
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