BS EN 1641:2009 牙科学.牙科用医疗器械.材料
This European Standard specifies general requirements for materials used in the practice of dentistry for the restoration of the form and function
Dentistry - Medical devices for dentistry - Materials
EN 1641:2009 牙科学.牙科用医疗器械.材料
This European Standard specifies general requirements for materials used in the practice of dentistry for the restoration of the form and function
Dentistry - Medical devices for dentistry - Materials
EN 1641:1996 牙科学.牙科用医疗器械.材料
Dentistry - Medical Devices for Dentistry - Materials
EN 1641:2004 牙科学.牙科用医疗器械.材料
Dentistry - Medical devices for dentistry - Materials
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
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
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
GB/T 42062-2022 医疗器械 风险管理对医疗器械的应用
Medical devices—Application of risk management to medical devices
YY/T 1474-2016 医疗器械 可用性工程对医疗器械的应用
IEC 62366:2014 医疗器械.医疗器械可用性工程的应用
Medical devices - Application of usability engineering 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
BS EN 1641:2009 牙科学.牙科用医疗器械.材料
This European Standard specifies general requirements for materials used in the practice of dentistry for the restoration of the form and function
Dentistry - Medical devices for dentistry - Materials
EN 1641:2009 牙科学.牙科用医疗器械.材料
This European Standard specifies general requirements for materials used in the practice of dentistry for the restoration of the form and function
Dentistry - Medical devices for dentistry - Materials
EN 1641:1996 牙科学.牙科用医疗器械.材料
Dentistry - Medical Devices for Dentistry - Materials
EN 1641:2004 牙科学.牙科用医疗器械.材料
Dentistry - Medical devices for dentistry - Materials
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
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
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
GB/T 42062-2022 医疗器械 风险管理对医疗器械的应用
Medical devices—Application of risk management to medical devices
YY/T 1474-2016 医疗器械 可用性工程对医疗器械的应用
IEC 62366:2014 医疗器械.医疗器械可用性工程的应用
Medical devices - Application of usability engineering 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
编辑：北检院编辑部
