中性电极的热性能评估与标准符合性研究

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Study on Thermal Performance Evaluation and Standards Compliance of NeutralElectrodes

LI Jianing1DING Yi² WANG Pengfei³ ZHANG Chao³* （1.Centre Testing International Group Co.，Ltd.;2.ProSteri Testing Shanghai Co.，Ltd.; 3. KingPo Technology Development Co.， Ltd.）

Abstract：With the widespreadapplicationof high-frequency electrosurgical devices inclinicalsurgery，thethermal performance and standards compliance of neutral electrodes，as critical safety components，are directly related to patient safety.BasedonthestandardGB97o6.202-2021，Medicalelectricalequipment—Part2-2：Particularrequirementsforthe basicsafetyandessentialperformanceof highfrequencysurgicalequipmentandhighfrequencysurgicalaccesories，this papersystematically interprets the heating mechanisms and standards compliance of neutral electrodes，and analyzes the scientificrationaleandimplementationrequirementsofthetestingcriteriaspecifiedinthestandard.Ithighlights theroot causes of discrepancies between the standard safety threshold （temperature rise ≤6∘C ）and the clinical theoretical limit （temperature rise ≤12∘C ，evaluatestherationalityof graded test current levels（ 350Ω-700mA ）validatedbythethermal factormodel Θ=I2×t） ，and explores the risk characteristics ofhigh-current modes （>30A2S） . It aims to provide anin-depth interpretationof thecorerequirementsof the standard clauses，offercriticalguidance forneutral electrodemanufacturers inachieving standards compliance，optimize product designpathways，andensure the safetyand compliancein clinical application，thereby providing technical assurance for the safe implementation of high-frequency electrosurgical procedures.

Keywords： neutral electrode; thermal performance; high-current mode

0 引言

高频电外科设备是一种通过高频电流（通常200kHz～5MHz ）作用于生物组织实现切割与凝血功能的医疗器械。（剩余5273字）