【英文标准名称】:Activeimplantablemedicaldevices-Generalrequirementsforsafety,markingandinformationtobeprovidedbythemanufacturer
【原文标准名称】:活性可植入医疗装置.制造商提供的安全,标记和信息的一般要求
【标准号】:BSEN45502-1-1998
【标准状态】:现行
【国别】:英国
【发布日期】:1998-02-15
【实施或试行日期】:1998-02-15
【发布单位】:英国标准学会(GB-BSI)
【起草单位】:BSI
【标准类型】:()
【标准水平】:()
【中文主题词】:包装;性能;试验设备;无线电波危害;电气试验;静电学;可混用性;电磁兼容性;修复装置;电压;生物分析和试验;无菌设备;介电强度试验;外科植入物;超声检验;去纤颤器;脉冲电压试验;防护电气设备;电气安全;试验条件;电驱动装置;修复术;超声危害;医用电气设备;耐久性;泄漏电流;温度;交付;危害;热试验;设计;电荷;包装件;机械试验;可靠度;事故预防;耐久试验;环境试验;寿命;作标记;安全措施;医疗设备;使用说明
【英文主题词】:Accidentprevention;Catheters;Clinics;Definition;Definitions;Determinations;Electricfields;Electricalappliances;Electrodes;Gaspressure;Handling;Hospitals;Implants(surgical);Ionizingradiation;Marking;Markings;Medicalequipment;Medicalsciences;Osmoticpressure;Packages;Patients;Protection;Safety;Safetyrequirements;Specification(approval);Sterility;Surgicalimplants;Surveys;Technicaldocuments;Testing
【摘要】:ThisPart1ofEN45502specifiesrequirementsthataregenerallyapplicabletoACTIVEIMPLANTABLEMEDICALDEVICES.ForparticulartypesofACTIVEIMPLANTABLEMEDICALDEVICES,theseessentialrequirementsaresupplementedormodifiedbytherequirementsofparticularstandardswhichformadditionalpartsofthisEuropeanStandard.TheteststhatarespecifiedinEN45502aretypetestsandaretobecarriedoutonsamplesofadevicetoshowcompliance.ThisPartofEN45502isapplicablenotonlytoACTIVEIMPLANTABLEMEDICALDEVICESthatareelectricallypoweredbutalsotothosepoweredbyotherenergysources(forexamplebygaspressureorbysprings).ThisPartofEN45502isalsoapplicabletosomenon-implantablepartsandaccessoriesofthedevices(seenote1).NOTE1.ThedevicethatiscommonlyreferredtoasanACTIVEIMPLANTABLEMEDICALDEVICEmayinfactbeasingledevice,acombinationofdevices,oracombinationofadeviceordevicesandoneormoreaccessories.Notallofthesepartsarerequiredtobeeitherpartiallyortotallyimplantable,butthereisaneedtospecifysomerequirementsofnon-implantablepartsandaccessoriesiftheycouldaffectthesafetyorperformanceoftheimplantabledevice.NOTE2.TheterminologyusedinthisEuropeanStandardisintendedtobeconsistentwiththeterminologyofDirective90/385/EEC.NOTE3.InthisEuropeanStandard,termsprintedinSMALLCAPITALLETTERSareusedasdefinedinclause3.Whereadefinedtermisusedasaqualifierinanotherterm,itisnotprintedinsmallcapitallettersunlesstheconceptthusqualifiedisalsodefined.
【中国标准分类号】:C35
【国际标准分类号】:11_040_40
【页数】:32P.;A4
【正文语种】:英语