发布时间：2023-05-25 10:10:19
点击量：0
有样品要送检？试试一键送检，5分钟极速响应
在线提交检测需求
对接客服咨询检测
YY/T 0615的本部分规定了标示“菌”的菌加工医疗器械的要求。 注：医疗器械只有当使用了一个确认过的灭菌过程，才可以标示“菌”。YY/T 0567规定了菌加工的确认和常规控制
Requirements for medical devices to be dwsignated“SIERILE”.Part 2:Requirements for aseptically processed medical devices
Sterilization of medical devices. Requirements for medical devices to be designated «sterile». Part 1. Requirements for terminally sterilized medical devices
Sterilization of medical devices; sterility assurance level for medical devices labelled "Sterile"; requirements
Medical devices. Application of risk management to medical devices
YY/T 0615的本部分规定了标示“ 菌”最终灭菌医疗器械的要求。YY/T 0615第2部分规定了标示“ 菌”的菌加工医疗器械的要求。 注：医疗器械只有当使用了一个确认过的灭菌过程，才可以标示“ 菌”.GB 18278、GB 18279、GB 18280、GB/T 19974、ISO
Requirements for medical devices to be designated“STERILE”.part 1:Requirements for terminally sterilized 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
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 usability engineering to medical devices
Medical devices. Application of usability engineering 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
YY/T 0615的本部分规定了标示“菌”的菌加工医疗器械的要求。 注：医疗器械只有当使用了一个确认过的灭菌过程，才可以标示“菌”。YY/T 0567规定了菌加工的确认和常规控制
Requirements for medical devices to be dwsignated“SIERILE”.Part 2:Requirements for aseptically processed medical devices
Sterilization of medical devices. Requirements for medical devices to be designated «sterile». Part 1. Requirements for terminally sterilized medical devices
Sterilization of medical devices; sterility assurance level for medical devices labelled "Sterile"; requirements
Medical devices. Application of risk management to medical devices
YY/T 0615的本部分规定了标示“ 菌”最终灭菌医疗器械的要求。YY/T 0615第2部分规定了标示“ 菌”的菌加工医疗器械的要求。 注：医疗器械只有当使用了一个确认过的灭菌过程，才可以标示“ 菌”.GB 18278、GB 18279、GB 18280、GB/T 19974、ISO
Requirements for medical devices to be designated“STERILE”.part 1:Requirements for terminally sterilized 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
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 usability engineering to medical devices
Medical devices. Application of usability engineering 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
首页
点击咨询
