标准编号：ISO 14971:2007
中文名称：医疗设备 对医疗设备风险管理的应用
英文名称：Medical devices — Application of risk management to medical devices
发布日期：2007-03
标准范围
This International Standard specifies a process for a manufacturer to identify the hazards associated withmedical devices, including in vitro diagnostic (IVD) medical devices, to estimate and evaluate the associatedrisks, to control these risks, and to monitor the effectiveness of the controls.The requirements of this International Standard are applicable to all stages of the life-cycle of a medicaldevice.This International Standard does not apply to clinical decision making.This International Standard does not specify acceptable risk levels.This International Standard does not require that the manufacturer have a quality management system inplace. However, risk management can be an integral part of a quality management system.
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