EN ISO 14971-2012 标准详情
- 标准号:EN ISO 14971-2012
- 中文标题:医疗设备 - 应用风险管理的医疗器械
- 英文标题:medical devices - application of risk management to medical devices
- 标准类别:欧盟标准EN
- 发布日期:2012-07-06
Describes 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 effectivene
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