GOST ISO 14971-2011 医疗器械.医疗器械风险管理应用
Medical devices. Application of risk management to medical devices
BS EN 62366-1:2015 医疗器械. 医疗器械可用性工程应用
Medical devices. Application of usability engineering to medical devices
BS EN 62366-1:2015+A1:2020 医疗器械. 医疗器械可用性工程应用
Medical devices. Application of usability engineering to medical devices
GOST R IEC 62366-2013 医疗器械. 医疗器械可用性工程应用
Medical devices. Application of usability engineering to medical devices
YY/T 0316-2016 医疗器械 风险管理对医疗器械的应用
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
YY/T 0316-2008 医疗器械.风险管理对医疗器械的应用
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
GB/T 42062-2022 医疗器械 风险管理对医疗器械的应用
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
EN ISO 14971:2019 医疗器械.医疗器械风险管理的应用
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
EN ISO 14971:2009 医疗器械.医疗器械风险管理的应用
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
EN ISO 14971:2007 医疗器械.医疗器械风险管理的应用
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
EN ISO 14971:2000 医疗器械.医疗器械风险管理的应用
Medical Devices - Application of Risk Management to Medical Devices (Incorporates Amendment A1: 2003)
NF S99-211:2013 医疗器械.医疗器械风险管理的应用
Medical devices - Application of risk management to medical devices
BS EN ISO 14971:2009 医疗器械.医疗器械风险管理的应用
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
BS EN ISO 14971:2012 医疗器械.医疗器械风险管理的应用
Medical devices. Application of risk management to medical devices
EN ISO 14971:2012 医疗器械.医疗器械风险管理的应用
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)
GOST ISO 14971-2011 医疗器械.医疗器械风险管理应用
Medical devices. Application of risk management to medical devices
BS EN 62366-1:2015 医疗器械. 医疗器械可用性工程应用
Medical devices. Application of usability engineering to medical devices
BS EN 62366-1:2015+A1:2020 医疗器械. 医疗器械可用性工程应用
Medical devices. Application of usability engineering to medical devices
GOST R IEC 62366-2013 医疗器械. 医疗器械可用性工程应用
Medical devices. Application of usability engineering to medical devices
YY/T 0316-2016 医疗器械 风险管理对医疗器械的应用
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
YY/T 0316-2008 医疗器械.风险管理对医疗器械的应用
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
GB/T 42062-2022 医疗器械 风险管理对医疗器械的应用
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
EN ISO 14971:2019 医疗器械.医疗器械风险管理的应用
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
EN ISO 14971:2009 医疗器械.医疗器械风险管理的应用
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
EN ISO 14971:2007 医疗器械.医疗器械风险管理的应用
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
EN ISO 14971:2000 医疗器械.医疗器械风险管理的应用
Medical Devices - Application of Risk Management to Medical Devices (Incorporates Amendment A1: 2003)
NF S99-211:2013 医疗器械.医疗器械风险管理的应用
Medical devices - Application of risk management to medical devices
BS EN ISO 14971:2009 医疗器械.医疗器械风险管理的应用
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
BS EN ISO 14971:2012 医疗器械.医疗器械风险管理的应用
Medical devices. Application of risk management to medical devices
EN ISO 14971:2012 医疗器械.医疗器械风险管理的应用
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)
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