| 医用测量、控制和实验室电气设备的风险管理 |
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| 引用本文： | 梁振士,刘毅,孙京昇,刘培.医用测量、控制和实验室电气设备的风险管理[J].医疗装备,2014(9):57-59. |
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| 作者姓名： | 梁振士 刘毅 孙京昇 刘培 |
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| 作者单位： | 北京市医疗器械检验所,北京101111 |
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| 摘 要： | 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。
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| 关 键 词： | 医用测量 控制和实验室电气设备 风险管理 |
Risk Management for Electrical Equipment in Medical Practice for Measurement,Control and Laboratory Use |
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| LIANG Zhen-shi,LIU Yi,SUN Jing-sheng,LIU Pei.Risk Management for Electrical Equipment in Medical Practice for Measurement,Control and Laboratory Use[J].Medical Equipment,2014(9):57-59. |
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| Authors: | LIANG Zhen-shi LIU Yi SUN Jing-sheng LIU Pei |
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| Institution: | (Beijing Institute of Medical Device Testing Beijing 101111 ) |
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| Abstract: | 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 . |
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| Keywords: | Electrical Equipment in Medical Practice for Measurement Control and Laboratory Use Risk Management |
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