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本文件规定了医疗器械(包括作为医疗器械的软件和体外诊断医疗器械)风险管理的术语、原则和过程。 本文件中描述的过程旨在帮助医疗器械制造商识别与医疗器械相关的危险,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。 本文件的要求适用于医疗器械生命周期的所有阶段。 本文件描述的过程适用于与医疗器械相关
Medical devices—Application of risk management 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
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
This International Standard specifies a procedure by which a manufacturer can identify the hazards associated with medical devices
Medical devices - Application of risk management to medical devices
This International Standard specifies a procedure by which a manufacturer can identify the hazards associated with medical devices
Medical devices - Application of risk management to medical devices
This International Standard specifies a procedure by which a manufacturer can identify the hazards associated with medical devices
Medical devices - Application of risk management to medical devices
Medical Devices - Application of Risk Management to Medical Devices (Incorporates Amendment A1: 2003)
Medical devices - Application of risk management to medical devices
This International Standard specifies a process for a manufacturer to identify the hazards associated with medical devices, including in vitro
Medical devices - Application of risk management to medical devices
Medical devices. Application of risk management to medical devices
This International Standard specifies a process for a manufacturer to identify the hazards associated withmedical devices, including in vitro
Medical devices - Application of risk management to medical devices (ISO 14971:2007, Corrected version 2007-10-01)
Specifies a process for a manufacturer to identify the hazards associated with medical devices, including in vitro diagnostic (IVD) medical devices
Medical devices - Application of risk management to medical devices
Medical devices — Application of risk management to medical devices
Medical devices — Application of risk management to medical devices
この規格は，製造業者がインビトロ診断機器を合む医療機器及びその附属品に関連するハザードを特定し，リスクの推定と評価を行い，これらのリスクをコントロールし，そのコントロールの有効性を監視する手順について規定する
Medical devices -- Application of risk management to medical devices
本文件规定了医疗器械(包括作为医疗器械的软件和体外诊断医疗器械)风险管理的术语、原则和过程。 本文件中描述的过程旨在帮助医疗器械制造商识别与医疗器械相关的危险,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。 本文件的要求适用于医疗器械生命周期的所有阶段。 本文件描述的过程适用于与医疗器械相关
Medical devices—Application of risk management 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
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
This International Standard specifies a procedure by which a manufacturer can identify the hazards associated with medical devices
Medical devices - Application of risk management to medical devices
This International Standard specifies a procedure by which a manufacturer can identify the hazards associated with medical devices
Medical devices - Application of risk management to medical devices
This International Standard specifies a procedure by which a manufacturer can identify the hazards associated with medical devices
Medical devices - Application of risk management to medical devices
Medical Devices - Application of Risk Management to Medical Devices (Incorporates Amendment A1: 2003)
Medical devices - Application of risk management to medical devices
This International Standard specifies a process for a manufacturer to identify the hazards associated with medical devices, including in vitro
Medical devices - Application of risk management to medical devices
Medical devices. Application of risk management to medical devices
This International Standard specifies a process for a manufacturer to identify the hazards associated withmedical devices, including in vitro
Medical devices - Application of risk management to medical devices (ISO 14971:2007, Corrected version 2007-10-01)
Specifies a process for a manufacturer to identify the hazards associated with medical devices, including in vitro diagnostic (IVD) medical devices
Medical devices - Application of risk management to medical devices
Medical devices — Application of risk management to medical devices
Medical devices — Application of risk management to medical devices
この規格は，製造業者がインビトロ診断機器を合む医療機器及びその附属品に関連するハザードを特定し，リスクの推定と評価を行い，これらのリスクをコントロールし，そのコントロールの有効性を監視する手順について規定する
Medical devices -- Application of risk management to medical devices
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