医疗器械可触及部分的确定方法研究

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Research on theDetermination Method ofAccessible Parts ofMedical Devices

DENG Zhenjin WUBitao TANG Guipeng ZHOU Yang CHEN Xinping SHI Rong XIE Lifeng （Hunan Institute forDrugControl）

Abstract：Objective：Fromtheperspectiveofmedicaldevicesafetytheaccessblepartsareaccuratelyandcompletelyfound， andtheleakage currentfowing intooroutof theseaccessbleparts orfowing between these accessible parts is measured， ensuringthatitdoesnotexceedthe specifiedlimitof thecontactcurrent.Method：Throughriskanalysisandresearchon standards，examplesareputforwardtoanalyzethedeterminationandtestmethodsofaccesibleparts.Result：Itcanhelpthe testinginstitutionsandthemanufacturingenterprisestoeffectivelyandaccuratelyidentifytheaccessibleparts，eliminate potentialsafetyrisks inmedical devices，and ensure thatthe productscomplywiththerelevantsafetystandards.Conclusion： Onlywith anin-depth andcomprehensive understanding ofthe standards development backgroundandaclear understanding oftheelectrical structureof the testedequipmentthrough structural inspection，canoneaccuratelyandcompletelyfind the accessble parts.This paperprovides guidance andreference formedical device testing institutions and manufacturers.

Keywords：accessible parts; touch current; normal use; normal condition; single fault condition

0 引言

可触及部分是指在正常使用或单一故障条件下，用户（包括患者和操作人员）可能用身体的一部分（如手指、手）直接或（项链、维修工具）间接接触的任何部分[1-2]。（剩余4857字）