| 医用电气设备电击危害的风险控制 |
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| 引用本文： | 迟戈,李非,王亚南,魏晶.医用电气设备电击危害的风险控制[J].中国药物警戒,2008,5(6). |
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| 作者姓名： | 迟戈 李非 王亚南 魏晶 |
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| 作者单位： | 1. 辽宁省药品不良反应监测中心,辽宁,沈阳,110003
2. 辽宁省医疗器械产品质量监督检验所,辽宁,沈阳,110179 |
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| 摘 要： | 从生产设计、应用、监管三个方面论述医用电气设备在电击危害风险控制过程中应采取的有效手段，以保证医用电气设备的使用安全。分析、阐述了生产该类产品的企业在风险管理中应涉及的风险控制重点以及药械监管部门在该类产品上市前审批和上市后不良事件监测方面应重点监管的内容。
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| 关 键 词： | 医用电气设备 电击危害 风险控制 |
Risk Control of Medical Electrical Equipment Shock Hazard |
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| CHI Ge,LI Fei,WANG Ya-nan,WEI Jing.Risk Control of Medical Electrical Equipment Shock Hazard[J].Chinese JOurnal of Pharmacovigilance,2008,5(6). |
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| Authors: | CHI Ge LI Fei WANG Ya-nan WEI Jing |
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| Abstract: | Discussing on the effective measures in risk control of medical electrical equipment shock hazard to ensure safety of medical equipment process. Tip on the control direction in the risk management should be involved for such production enterprises and the content focused on monitoring and control should be the approval of pre-marketing products and post-marketing adverse events for drug administration departments. |
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| Keywords: | medical electrical equipment electric shock risk risk control |
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