医用测量、控制和实验室电气设备的风险管理

Risk Management for Electrical Equipment in Medical Practice for Measurement,Control and Laboratory Use

本文立足于医用测量、控制和实验室电气设备特殊性,按照IEC61010-1标准第三版和ISO14971标准的要求,给出了该类产品涉及的风险范围、风险管理过程及实施方法。

For electrical equipment in medical practice for measurement , control and laboratory use , the manufacturer shall es-tablish a risk management process beyond the requirements specified in IEC 61010-1： 2010.The scope of risks that shall be ana-lyzed, the process and the key points of application of risk management are provided in this paper .