ISO 14971:2007 医疗设备 对医疗设备风险管理的应用

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

ISO 14971:2007规定了制造商识别与医疗设备（包括体外诊断（IVD）医疗设备）相关的危害、估计和评估相关风险、控制这些风险以及监控控制有效性的过程。ISO 14971:2007的要求适用于医疗器械生命周期的所有阶段。

ISO 14971:2007 specifies a process for a manufacturer to identify the hazards associated with medical devices, including in vitro diagnostic (IVD) medical devices, to estimate and evaluate the associated risks, to control these risks, and to monitor the effectiveness of the controls.The requirements of ISO 14971:2007 are applicable to all stages of the life-cycle of a medical device.

标准预览图