DS/ISO 20417:2021 医疗器械 制造商需提供的信息
Medical devices – Information to be supplied by the manufacturer
UNE-EN ISO 20417:2021 医疗器械 制造商需提供的信息
Medical devices - Information to be supplied by the manufacturer (ISO 20417:2021, Corrected version 2021-12)
NF EN ISO 20417:2021 医疗器械 制造商需提供的信息
Dispositifs médicaux - Informations à fournir par le fabricant
SANS 15223:2006 医疗器械．需要与医疗器械一起提供的标签，标识和信息用符号
Identifies symbols conventionally used to convey information essential for safe and effective use of medical devices. It is primarily intended for use
Medical devices - Symbols to be used with medical device labels, labelling and information to be supplied
DD ISO/TS 10993-20:2006 医疗器械的生物学评价 医疗器械免疫毒理学检测原理和方法
Biological evaluation of medical devices. Principles and methods for immunotoxicology testing of 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
KS C CISPR 23-2004 工业、科学、医疗器械限定值的设定
서 문 이 규격은 1987년 12월에 초판으로 발행된 CISPR 23 Determ
Electromagnetic compatibility(EMC)-Determination of limits for industrial, scientific and medical equipment
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
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
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
DS/ISO 20417:2021 医疗器械 制造商需提供的信息
Medical devices – Information to be supplied by the manufacturer
UNE-EN ISO 20417:2021 医疗器械 制造商需提供的信息
Medical devices - Information to be supplied by the manufacturer (ISO 20417:2021, Corrected version 2021-12)
NF EN ISO 20417:2021 医疗器械 制造商需提供的信息
Dispositifs médicaux - Informations à fournir par le fabricant
SANS 15223:2006 医疗器械．需要与医疗器械一起提供的标签，标识和信息用符号
Identifies symbols conventionally used to convey information essential for safe and effective use of medical devices. It is primarily intended for use
Medical devices - Symbols to be used with medical device labels, labelling and information to be supplied
DD ISO/TS 10993-20:2006 医疗器械的生物学评价 医疗器械免疫毒理学检测原理和方法
Biological evaluation of medical devices. Principles and methods for immunotoxicology testing of 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
KS C CISPR 23-2004 工业、科学、医疗器械限定值的设定
서 문 이 규격은 1987년 12월에 초판으로 발행된 CISPR 23 Determ
Electromagnetic compatibility(EMC)-Determination of limits for industrial, scientific and medical equipment
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
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
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
编辑：北检院编辑部
