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高频手术设备标准GB9706.4-2009条款59.104.5检测方法研究

The Research of Clause 59.104.5 Detection Method of High Frequency Surgical Equipment
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摘要 高频手术设备在电外科手术中得到了越来越广泛的应用,设计不当会引起灼伤,附件中性电极的性能直接影响到产品的安全性。高频手术设备标准GB9706.4-2009条款59.104.5是测试中性电极接触部位的温升,避免患者接触部位受到热损伤风险。本文旨在对此检测方法进行研究。 High frequency surgical equipment has been widely used in electrosurgery, improper design can cause burn, the performance of accessory of neutral electrode directly affects the safety of products. The clause 59.104.5 of high frequency surgical equipment standard GB9706.4-2009 is to test the temperature rise of the neutral electrode application site, and to avoid risk of thermal injury at the neutral electrode application site.This paper aims to study this test method.
作者 陈聪
出处 《中国医疗器械信息》 2015年第11期46-49,共4页 China Medical Device Information
关键词 高频手术设备 中性电极 温升 high frequency surgical equipment Neutral electrode temperature rise
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参考文献2

  • 1GB9706.4—2009《医用电气设备第二部分:高频手术设备安全专用要求》.
  • 2IEC 60601-2-2 Medical electrical equipment-Part 2-2: Particular requirements for the safety of high frequency surgical equipment.

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