EN_IEC60601-1_&_MDD_Seminar

MedicalProductofProductSafetyandQuality1WelcomeWelcometotheseminarIEC/EN60601-1MDDPaulHung2003-03-05MedicalProductofProductSafetyandQuality2WhatisMedicalDevice?TheDefinitionsofMedicalDevice:1.Properapplicationintendedbythemanufacturer2.Diagnosis,prevention,monitoring,treatmentoralleviationofdisease3.Diagnosis,monitoring,treatment,alleviationoforcompensationforinjuryorhandicap4.Investigation,replacementormodificationoftheanatomyorofaphysiologicalprocess5.Controlofconception6.Notachieveitsprincipalintendedactioninoronthehumanbodybypharmacological,immunologicalormetabolicmeansMDD93/42/EECArticle1MedicalProductofProductSafetyandQuality3HowtogetintotheEuropeanMarket?Becauseofthe“Liberalization”and“Harmonization”,thebigEuropeanMarketwithoutfrontiersisvisible.But,howtogettheCEconformitymark??IntroductionofRequirementMedicalProductofProductSafetyandQuality4Structureoftheseminar1.MDDIEC60601-1MDD2.IEC60601-13.TechnicalDoc.4.Workshop5.BPMMedicalProductofProductSafetyandQuality5Whendoesitstart?June,1993Introduction:MDD(MedicalDevicesDirective)14.June.1998MedicalProductofProductSafetyandQuality693/42/EECMDD01.01,95TransitionalperiodCEmarking13.06,9814.06,98CEmarkingismandatoryIntroduction:NewMDDLegislationMedicalProductofProductSafetyandQuality7MDDProductSafety:IEC60601-1,EMC,EssentialRequirements..NotifiedBodyTÜVRheinlandISO9001EN46001MDDAuditMedicalDevice?Classl,lla,llborIII?EURep.VigilanceSysConsultantContract,DocumentWhatisMDD?MedicalProductofProductSafetyandQuality8ProductSafetyMDDActiveDeviceNonActiveDeviceSystemTechnicalDesign,Construction,Installation,Connectionrequirement,Maintenance,Repair,Handling,Component…ProductSafetyMedicalSelectionoftreatment,Dosageregulation,Devicesettingparameters...HygieneCare,Cleaninganddisinfectingofdevice,Sterilizationofcomponent...ISO9001:2000EN46001:1996ISO13485:200XMedicalProductofProductSafetyandQuality9AnnexI=EssentialRequirementSafetyFirstEliminateorreduceRisksasmuchaspossible:RiskAnalysis,RiskmanagementElectricalRisks,EnergyhazardsEMC,Physical/Chemical/Biologicalproperty,Radiation.Deviceshavingameasuringfunction:AccuracyInformationforpatients,users,services:Label,Instructionforuse,Packaging,ServicemanualProductsafeRequirementsMedicalProductofProductSafetyandQuality10ParticularRequirementofProductSafetyProductSafetyElectricalSafetyIEC60601-1&othersIEC60601-1-2EMCTechnicalaidsforDisabledpersonEN12182TechnicalAidsEN12183Manu.WheelchairEN12184Elec.WheelchairothersBiocompatibilityeval.EN30993-1/ISO10993ser.OthersMedicalProductofProductSafetyandQuality11IntroductionofstandardIEC60601-1&itsfamilyIEC60601-160601-1-160601-1-260601-1-360601-1-4GeneralrequirementCollateralrequirementParticularrequirementSystemEMCX-raySoftware60601-2-160601-2-260601-2-5060601-2-2260601-2-30MedicalElectronAcceleratorsHFSurgicalEquipmentMedicalLaserContinuousBPMInfantPhototherapyEquipmentMedicalProductofProductSafetyandQuality12TÜVRheinland:NotifiedBody&CertificationBodyAccreditationBodyTestingLab.CertificationBodyCBNotifiedBodyCE0197TÜVRheinlandMedicalProductofProductSafetyandQuality13IEC60601-1:1988+A1:1991+A2:19951.MDDIEC60601-1MDD2.IEC60601-13.TechnicalDoc.4.Workshop5.BPMMedicalProductofProductSafetyandQuality14WhyaretherequirementsofIEC60601-1sodifficulttomeet?ProductSafetyisveryimportantforMedicalDevice,becauseInabilityofPatientorOperatortodetectpotentialhazardsReactionofPatientisdelayed(Illness;Unconsciousness;Anaesthetized;Immobilize)Absenceofnormalskinprotection(e.g.lowskinresistance)SupportofbodyfunctionmaydependonreliabilityofequipmentApplicationofelectricalcurrentdirectlytothehumanbodySpecialenvironmentalconditionsAnnexAofIEC60601-1MedicalProductofProductSafetyandQuality15Electrical(maintopicofthislecture)Mechanical(cutting,bruise,….)Thermal(heatingtest)Fire(insulation,heating,abnormal,constructionoffireenclosure)EMC(IEC60601-1-2)Chemical(useofdangerousliquids,gas)HazardousOutputs(e.g.Laser,X-Ray,….)Biological(IEC60601-1clause48:Biocompatibility)HazardsTypecausedbyelectricaldevices:MedicalProductofProductSafetyandQuality16ApartofequipmentwhichcomesintophysicalcontactwithPatients.Ftype(floatingtype)AppliedPartshavehigherdegreeofprotection(leakagecurrent)BstandsforBody;CstandsforCardiacAppliedPartsIEC878-02-02IEC417-5333IEC878-02-03IEC417-5335IEC878-02-05TypeBequipmentTypeBFequipmentTypeCFequipmentIEC60601-1Cl.2.1.5MedicalProductofProductSafetyandQuality17LimitationofVoltageandEnergy/DischargeTestIEC60601-1Cl.15/IEC60950Cl.2.1.10IEC60601IEC60950Voltage60Vafter1st(37%ofV0)1s(PluggabletypeA)10s(PluggabletypeB)max.capacitancebetweenL/Nandenclosure(w/otesting)Y-Cap.interferencesuppressioncapacitor3000pF(250V)5000pF(125V)interferencesuppressioncapacitor0.1mFmax.capacitancebetweenLandN(w/otesting)X-Cap.interferencesuppressioncapacitor0.1mFinterferencesuppressioncapacitor0.1mFComparisonMedicalDevicesITequipmentMedicalProductofProductSafetyandQuality18LeakageCurrentLimitationIEC60601-1Cl.19N.CS.F.CN.CS.F.CN.CS.F.C0.010.050.010.050.010.050.10.50.10.50.010.050.010.050.010.050.010