Risk Management Process in a Microwave Thermal Ablation System for CE Marking

机译：用于CE标记的微波热消融系统中的风险管理过程

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Microwave thermal ablation (MWA) is a promising technique capable of achieving larger ablation zones quicker than other energy forms. The aim of this work is the risk management of a brand new microwave thermal ablation system, for the purpose of CE marking. The risk analysis will be driven by a multidimensional Failure Mode, Criticality and Effect analysis, which will take into account the effects on the patient, the operator and the hospital facility. All the principal mitigation interventions found will be described.

机译：微波热消融（MWA）是一种希望能够比其他能量形式更快地实现更大消融区域的有希望的技术。这项工作的目的是一个全新的微波热消融系统的风险管理，用于CE标记。风险分析将由多维失效模式，临界性和效果分析驱动，这将考虑对患者，操作员和医院设施的影响。将描述发现的所有本金缓解干预措施。

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《Mediterranean Conference on Medical and Biological Engineering and Computing》|2013年||共4页
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E. Iadanza; C. Ignesti; G. Biffi Gentili;
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中图分类生物医学工程;
关键词
Microwave; thermal ablation; CE marking; FMEA; risk management.;

机译：微波;热烧蚀;CE标记;FMEA;风险管理。;

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2. The comparative of the performance for predicted thermal models during microwave ablation process using a slot antenna [J] . Wutipong Preechaphonkul, Phadungsak Rattanadecho Case Studies in Thermal Engineering . 2020,第a期

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4. Risk Management Process in a Microwave Thermal Ablation System for CE Marking [C] . E. Iadanza, C. Ignesti, G. Biffi Gentili Mediterranean Conference on Medical and Biological Engineering and Computing . 2013

机译：用于CE标记的微波热消融系统中的风险管理过程
5. Antenna and System Design for Controlled Delivery of Microwave Thermal Ablation [D] . Fallahi, Hojjatollah. 2020

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6. A clinical study of thermal monitoring techniques of ultrasound-guided microwave ablation for hepatocellular carcinoma in high-risk locations [O] . Han Zhi-yu, Liang Ping, Yu Xiao-ling, -1

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8. Manual for the classification and prioritization of risks due to major accidents in process and related industries. Inter-Agency programme on the assessment and management of health and environmental risks from energy and other complex industrial systems [R] . 1996

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Risk Management Process in a Microwave Thermal Ablation System for CE Marking

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