BS EN 45502-2-1-2003 装饰用高压层压板材(HPL).基于热固性树脂的薄板材(通常称为层压板材).内墙、外墙和天花板终饰用压实层压板材和HPL复合板材
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【英文标准名称】:Activeimplantablemedicaldevices-Part2-1:Particularrequirementsforactiveimplantablemedicaldevicesintendedtotreatbradyarrhythmia(cardiacpacemakers)
【原文标准名称】:装饰用高压层压板材(HPL).基于热固性树脂的薄板材(通常称为层压板材).内墙、外墙和天花板终饰用压实层压板材和HPL复合板材
【标准号】:BSEN45502-2-1-2003
【标准状态】:作废
【国别】:英国
【发布日期】:2003
【实施或试行日期】:2003
【发布单位】:英国标准学会(GB-BSI)
【起草单位】:
【标准类型】:()
【标准水平】:()
【中文主题词】:
【英文主题词】:Implants(surgical);Prostheticdevices;Prosthesis;Medicalequipment;Pacemakers;Cardiology;Electricalmedicalequipment;Heart;Pulsegenerators;Signalgenerators;Pulsecircuits;Accuracy;Electricalimpedance;Testequipment;Marking;Sensitivity
【摘要】:ThisPart2-1specifiesrequirementsthatareapplicabletothoseACTIVEIMPLANTABLEMEDICALDEVICESintendedtotreatbradyarrhythmias.TheteststhatarespecifiedinEN45502aretypetests,andaretobecarriedoutonsamplesofadevicetoshowcompliance.ThisPart2-1isalsoapplicabletosomenon-implantablepartsandaccessoriesofthedevices(seeNote1).ThecharacteristicsoftheIMPLANTABLEPULSEGENERATORorLEADshallbedeterminedbyeithertheappropriatemethoddetailedinthisPart2-1orbyanyothermethoddemonstratedtohaveanaccuracyequalto,orbetterthan,themethodspecified.Inthecaseofdispute,themethoddetailedinthisPart2-1shallapply.AnyfeaturesofanACTIVEIMPLANTABLEMEDICALDEVICEintendedtotreattachyarrhythmiasarecoveredbyEN45502-2-2.NOTE1ThedevicethatIscommonlyreferredtoasanactiveimplantablemedicaldevicemayinfactbeasingledevice,acombinationofdevices,oracombinationofadeviceordevicesandoneormoreaccessories.Notallofthesepartsarerequiredtobeeitherpartiallyortotallyimplantable,butthereisaneedtospecifysomerequirementsofnon-implantablepartsandaccessoriesiftheycouldaffectthesafetyorperformanceoftheimplantabledevice.NOTE2TheterminologyusedinthisEuropeanStandardisintendedtobeconsistentwiththeterminologyofDirective90/385/EEC.NOTE3InthisEuropeanStandard,termsprintedinsmallcapitallettersareusedasdefinedinClause3.Whereadefinedtermisusedasaqualifierinanotherterm,itisnotprintedinsmallcapitallettersunlesstheconceptthusqualifiedisalsodefined.
【中国标准分类号】:G33
【国际标准分类号】:11_040_40
【页数】:98P.;A4
【正文语种】:英语
【原文标准名称】:装饰用高压层压板材(HPL).基于热固性树脂的薄板材(通常称为层压板材).内墙、外墙和天花板终饰用压实层压板材和HPL复合板材
【标准号】:BSEN45502-2-1-2003
【标准状态】:作废
【国别】:英国
【发布日期】:2003
【实施或试行日期】:2003
【发布单位】:英国标准学会(GB-BSI)
【起草单位】:
【标准类型】:()
【标准水平】:()
【中文主题词】:
【英文主题词】:Implants(surgical);Prostheticdevices;Prosthesis;Medicalequipment;Pacemakers;Cardiology;Electricalmedicalequipment;Heart;Pulsegenerators;Signalgenerators;Pulsecircuits;Accuracy;Electricalimpedance;Testequipment;Marking;Sensitivity
【摘要】:ThisPart2-1specifiesrequirementsthatareapplicabletothoseACTIVEIMPLANTABLEMEDICALDEVICESintendedtotreatbradyarrhythmias.TheteststhatarespecifiedinEN45502aretypetests,andaretobecarriedoutonsamplesofadevicetoshowcompliance.ThisPart2-1isalsoapplicabletosomenon-implantablepartsandaccessoriesofthedevices(seeNote1).ThecharacteristicsoftheIMPLANTABLEPULSEGENERATORorLEADshallbedeterminedbyeithertheappropriatemethoddetailedinthisPart2-1orbyanyothermethoddemonstratedtohaveanaccuracyequalto,orbetterthan,themethodspecified.Inthecaseofdispute,themethoddetailedinthisPart2-1shallapply.AnyfeaturesofanACTIVEIMPLANTABLEMEDICALDEVICEintendedtotreattachyarrhythmiasarecoveredbyEN45502-2-2.NOTE1ThedevicethatIscommonlyreferredtoasanactiveimplantablemedicaldevicemayinfactbeasingledevice,acombinationofdevices,oracombinationofadeviceordevicesandoneormoreaccessories.Notallofthesepartsarerequiredtobeeitherpartiallyortotallyimplantable,butthereisaneedtospecifysomerequirementsofnon-implantablepartsandaccessoriesiftheycouldaffectthesafetyorperformanceoftheimplantabledevice.NOTE2TheterminologyusedinthisEuropeanStandardisintendedtobeconsistentwiththeterminologyofDirective90/385/EEC.NOTE3InthisEuropeanStandard,termsprintedinsmallcapitallettersareusedasdefinedinClause3.Whereadefinedtermisusedasaqualifierinanotherterm,itisnotprintedinsmallcapitallettersunlesstheconceptthusqualifiedisalsodefined.
【中国标准分类号】:G33
【国际标准分类号】:11_040_40
【页数】:98P.;A4
【正文语种】:英语
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