introduction to medical emc - ieee · 2017-12-15 · medical emc requirements • requirements are...
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DarrylP.RayPrincipalConsultant
DarrylRayEMCConsulting,LLC
925-487-0072
www.dray-emc.com
1
Introduction to Medical EMC
Introduction toMedicalEMC,IEEESCVDec2017Copyright2017DarrylRayEMCConsulting,LLCdray-emc.com
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Scope
Thispresentationfocuseson:
MedicalElectricalDevicesand
MedicalElectricalSystemsonly
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IEC 60601/80601 Series of Standards
• Safetystandards• Patient• Operator• Environment
• EssentialPerformancecovered
• Over80standards&growing
• 80601=JointIEC/ISOstandard
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Medical Device Requirements Hierarchy
Precedence
4Introduction toMedicalEMC,IEEESCVDec2017Copyright2017DarrylRayEMCConsulting,LLCdray-emc.com
Regulations
Particular StandardsDeviceSpecific (Vertical)
IEC/ISO80601-2-X
Collateral StandardsApplytoAllDevices(Horizontal)
IEC60601-1-X
Referenced Standards(e.g.IEC61000-4-X)
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5
Requirements
60601-2-4
Particular requirements
Defibrillator/ monitors
60601-2-3
Particular requirements
Short-wave therapy equipment
60601-2-2
Particular requirements
HF surgical equipment
60601-2-1
Particular requirements
Medical accelerators
Particularstandards
80+standards
Amendsthegeneralrequirementsforspecifictypesofequipmentandtakeprecedence!
60601-1-3General requirements
60601-1-2General requirements
60601-1-1General requirements
60601-1General requirements
GeneralStandardAppliestoallequipment
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ISO Particular Standard Example – IEC 60601-2-54:2009
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Medical EMC Requirements
• RequirementsaregenerallyperIEC60601-1-2
• EN60601-1-2isequivalent
• Particularstandards(IEC80601-2-X)maymodifyimmunitylevelsandacceptancecriteria
• IEC60601-1-24th editionpublishedFebruary2014
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What is Essential Performance (EP)?
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• DealswithSafetyRelated Performance
devicecanbesusceptible butmuststaysafe
• DefinedBy:
• IEC/ISO80601-2-X(ifapplicable)• IEC60601-1Edition3.1(seecl3.27&4.3)• Manufacturemaybroadenthescope– Usingriskanalysis
• SomedeviceshavenoEssentialPerformance
• Relevance:ImmunityacceptancecriteriaislinkedtoEP
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What is Essential Performance?
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FromIEC60601-1:2005+A1:2012
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Essential Performance - Example
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FromIEC60601-2-37:2015
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More on Essential Performance
11 |
• EMCSusceptibilitydoesnotalwaysequalfailure!
• EssentialPerformancecannotbe“compliedwith”
(mustbemaintained)
• TheRiskManagementFileshouldrelatetothedefinitionofEP
(entriesmuststateunacceptablerisk)
• ManytestlabsdonotunderstandEP
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3rd Editionhasbeenwithdrawn
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Motivation
13
• Aimwastocreateasafety standardwithrespecttoEMdisturbances
• Drawbackswiththe3rdEdition;• BasicSafetyandEssentialPerformanceaspectshavenotbeen
adequatelyaddressed
• TestLevelsinthecurrentstandardarenearly20yearsold(NewEMenvironmentsunaccountedfor,e.g.cellphones)
• Mobiledeviceusagerestrictionsarenowgenerallyignored
• DevicesinthesameuselocationmeetdifferentimmunityLevels
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The Real World!
PhotocourtesyofDr.DavidHTScott,DepartmentofAnesthetics,TheRoyalInfirmaryofEdinburgh,UnitedKingdom
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4th Edition - General
Immunityrequirementsnowbasedonthreeuserenvironments
• ProfessionalHealthcare(hospital&smallclinic)
• HomeHealthcare(mostlocationsoutsidethehospital/smallclinic)
• Special(determinedonacase-by-casebasis)
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Intended Use Locations Examples
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4th Edition - General
• ACinputvoltagerequirementsclarified• Streamlinedtoonevoltage/frequency
(exception:VoltageDips&Interrupts)
• Regulatorsmayrequiretestingusingnationalvoltages
• TestingofI/Oports(SIP/SOPS)clarified
• ThePotentialEqualizationConductorTerminal(if applicable) mustbeconnectedduringtesting
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Potential Equalization Conductor Terminal
Ref.IEC60601-1Edition3.1,Figure2
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4th Edition - Emissions
• MustcomplywithCISPR11,IEC6100-3-2/3
• Standbymodeshouldbeconsidered
• RequirementsofCISPR14-1limitedtoswitchingdevicesandmotors
• RequirementsofCISPR15eliminated
• ITEequipmentmustmeetCISPR32(notCISPR22)
• X-Raygeneratorsallowed20dBrelaxation(intermittentmode)
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4th Edition - Immunity
• Immunitypass/failcriteriaisbasedonEssentialPerformanceandBasicSafetyonly
• Specificfailureattributesfrom3rd editionarenolongerspecified
• Immunity testlevelsarebasedonuselocation(notthedevicetype)
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4th Edition - Immunity
• Higherimmunitytestlevelsinsomeinstances
• Standbymodeshouldbeconsidered
• ESD• IncreasedESDtestlevels
• ModifiedESDtestmethodonconnectors
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4th Edition - Immunity
• TransmitterExclusionBandeliminated(RadiatedImmunityOnly)
• TestingonDCinputportconditionallyrequired(PermanentCables>3m)
• Provisionaddedtoaddresstestsamplesdamagedduringtesting
• Twonewimmunitytestsadded
• CloseFieldProximity
• 12VDCSurge
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4th Edition - Immunity
• Conductedimmunitylevelsincreasedinsomecases
• ModifiedVoltageDips&Interruptstesting
• MagneticImmunitytestlevelssignificantlyincreased
• ArtificialHandtestingrequirementsclarified
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Phenomenon IEC60601-1-2:3rd Edition
IEC60601-1-2:4th Edition
Prof.HealthcareEnvironment
HomeHealthcareEnvironment
ESD 8kVAirDischarge(max.)6kVContactDischarge
15kVAirDischarge(max.)8kVContactDischarge
EFT/Burst2kV- ACMains1kV- I/OPorts
5kHzor100kHzPRR
2kVACMains1kVI/OPorts100kHzPRR
Surges(ACMains) 2kV 2kV
Bold=ChangesFromthe3rd edition
Comparison of Immunity Levels
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Phenomenon IEC60601-1-2:3rd Edition
IEC60601-1-2:4th Edition
Prof.HealthcareEnvironment
HomeHealthcareEnvironment
Magnetic Immunity(50/60Hz) 3A/M 30A/M
ConductedImmunity3V(0.15- 80MHz)10VISMBands(LifeSupport)
3V(0.15- 80MHz)
6V(ISMBands)
3V(0.15- 80MHz)
6V (ISM +Amateur)
VoltageDips&Interrupts
•UT <5%,0.5periods
•UT =40%,5periods
•UT =70%,25periods
•UT<5%,5seconds
• UT=0%,0.5cycle(0,45, 90,135,180,225,270and315°)
• UT=0%;1cycleUT=70%;25/30cycles(@0degrees)
• UT=0%;250/300cycle
Bold=ChangesFromthe3rd edition
Comparison of Immunity Test Levels (cont.)
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PhenomenonIEC60601-1-2:3rd Edition
IEC60601-1-2:4th Edition
Prof.HealthcareEnvironment
HomeHealthcareEnvironment
RadiatedImmunity
3V/m- NotLifeSupport10V/m- LifeSupport
80MHz– 2.5GHz
80%@2Hz(or1kHz)AMModulation
3V/m
80MHz– 2.7GHz
80%@1kHzAMModulation
10V/m
80MHz– 2.7GHz
80%@1kHzAMModulation
ProximityFieldfromWirelessTransmitters(NewTest)
N/A9V/mto28V/m
15specific frequencies
Bold=ChangesFromthe3rd edition
Comparison of Immunity Test Levels (cont.)
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TestFrequency(MHz)
TestLevel(Volts/meter)
Modulation(@50%duty
cycle)
Communication Service(partiallist)
385 27 18Hz TETRA400
450 28 FM(5kHz deviation)
GMRS/FRS
710,745,780 9 217Hz LTE
810,870,930 28 18Hz GSM800
1720,1845,1970 28 217Hz GSM1800
2450 28 217Hz RFID
5240,5500,5785 9 217Hz WLAN
Close Field Proximity Test Levels
Basedon0.3mSeparationDistance
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Phenomenon IEC60601-1-2:3rd Edition
IEC60601-1-2:4th Edition
Prof.HealthcareEnvironment
HomeHealthcareEnvironment
Electrical Transients -Vehicle
12VPowered(NewTest)
N/A N/A ISO7637-2Pulses– 600Vmax.
Bold=ChangesFromthe3rd edition
Comparison of Immunity Levels (cont.)
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ESD Testing on Connectors
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ConnectorShell DischargeRequirements ConnectorUsage
Metallic ContactDischargetoShellOnly INTENDEDUSE
NonMetallic• AirDischarge toShell• AirDischarge toPins(ifReachablebyTestFinger)
INTENDED& NORMALUSE
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IntendedUse– ClinicalUseOnlyNormalUse– IntendedUsePlus Maintenance,StandbyMode,etc.
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4th Edition – ESD Testing Example
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RJ45EthernetConnector(Non-Metallic)
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EMC Risk Management – Tabular Summary
Clause Requirement
4.1 VerifythatRMentries arepresent intheRMF
4.2 NonMEEquipmentusedwithMedicalElectrical Systems
4.3.1 Verifytestconfiguration
8.1 Effectsobservedduringimmunitytesting shallbeanalyzed
8.1Pass/FailCriteriaandmethodofmonitoringshallbelisted intheRMF
8.1Assess theEMenvironmentandaddadditionalEMCtests asnecessary
8.1 Willatleast (1)ofeachtypeofportbeconnectedduringtesting?
8.1Areanyspecial environmentsdefinedthatjustifynon-standardtest levels?
8.1Will theMEintendeduse includetypesoftransportation(sea,air,vehicle)orusednearRFIDoranti-theft devices?
8.1Will theMEbeused intheemergencymedical servicesenvironment?
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EMC Risk Management - Tabular Summary
Clause Requirement
8.1 Isthedwelltime forbasedonthetimerequiredfortheMEtobeexercisedandadequatelyrespondtothetestsignal?
8.5 Assessment ofsubsystemtesting
8.7 Selection ofoperatingmodes
8.8 UseofNonMEequipment
8.9 Aremodified immunitytest levelsandmodulations used?
8.10 Takeintoconsideration currentcommunication services
Table3 Equipmentthat isdamagedduringimmunitytesting
Table4 Modified immunity levelsmaybeused
Table9 Considerreduceddistance tomobile communicationdevices
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4th Edition – Risk Management
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Integration with Non Medical Equipment
• MustnotcompromisethesystemEssentialPerformanceandBasicSafety
• Non-medicalequipmentmustcomplywithapplicablestandards
• ITE(multimedia)mustcomplywithCISPR32(notCISPR22)
4th Edition
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What’s the EUT?
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ACPowerInput
LAN Port
ACPowerSource
PCwithDisplay,Printer,Keyboard&Mouse
LANPort
LANCable
ACPowerSource
MedicalDevice
SoldasanAccessory
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Testing with Non Medical Devices Attached
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Clause4.2
• non-MEEQUIPMENTusedinanMESYSTEMshallcomplywithIECandISOEMCstandardsapplicabletothatequipment;
• non-MEEQUIPMENTusedinanMESYSTEMforwhichtheintendedEMENVIRONMENTcouldresultinthelossofBASICSAFETYorESSENTIALPERFORMANCEoftheMESYSTEMduetothenon-MEEQUIPMENTshallbetestedaccordingtotherequirementsofthiscollateralstandard.
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Is Non Medical Equipment Required to be Tested?
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ForImmunitytesting,useRiskAnalysistodetermineifEP/BScouldbecompromised:
• Ifyes– testingisrequired
• Ifno– testingisnotrequired
• Ifunknown– testingisrequired
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Thetestplancontentsareinformative
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4th Edition – Documentation
39
• Labelingrequirementsmodified&partiallystreamlined–EMCtablesdeleted
• EMCtestplanrequired,recommendedcontent
• EMCtestreportrequired,minimumcontentdefined
• RiskManagement– numerousEMCconsiderationsrequired
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Documentation
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4th Edition - Documentation
• CISPR11ClassAemissionswarningstatement(textdiffersfromCISPR11)
• Labelingrequirementsmodified(EMCtablesdeleted- butmaystillbeusedifdesired)
• EMCtestplanrequired- recommendedcontent
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4th Edition - Documentation
• EMCtestreportrequired- minimumcontentspecified
• Referencedstandards- dated referencesspecified
• CISPR11Edition5.1specified,Edition6.1published
• Riskmanagementprocess– numerousEMCconsiderationsrequired
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• NoLongerRequired;
• Emissionscompliancetable
• Immunitycompliancetable
• Immunity(transients)compliancetable
• Separationdistancetable
• NoLongerAllowed;
• I/OPortESDexemption&marking
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abbreviated
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IEC 60601-1-2, 4th Edition - Labelling
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Declaring Compliance to IEC 60601-1-2
Item Edition3 Edition4
Testplan X(suggestedcontent)
Allapplicable testsmustpass X X
Testreport X X(specifiedcontent)
Labelling compliance X X
RiskManagement File(addressingEMC)
X
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46
4th edition versus 3rd Edition
Does Compliance to the 4th Editionconstitute compliance to 3rd Edition?
Answer: No Way !
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When Do We Have to Comply with the 4th Edition?
United States European UnionCanada OtherRegions
Legacy Devices:Never*
NewSubmittals:January 1,2019
January 1,2019Variesby:
TheCountry**Part2Standards
Notes*PerFDAsubstantialequivalence (predicate)scheme**Somecountriesdonotpresentlyacceptthe4th Edition
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What Does All This Mean?
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• LegacyProducts- ToComplywiththe4th Edition(minimum):• RetestingisRequired;
• w/PotentialEqualizationConductorattached(if applicable)• EmissionsinStandbyMode• ModifiedImmunityPass/Failcriteria• ModifiedImmunityTestRequirementsperclause8• NewTests– CloseFieldProximity&VehicleSurge
• LabelingModifications
• RiskManagement– Additionstothefile
• NewDesigns– recommend4thEdition– butconsiderinternationalrequirements
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IEC TR 60601-4-2:2016
• Initialplan– Includedin60601-1-2:2016- AnnexJ
• Deletedatthelastminute
• Separatestandalonedocument
• IECversiononly– NocorrespondingENplanned
• RegulatoryRequirement?
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IEC TR 60601-4-2:2016
• Thisisarecommendation– theterm“shall”isusedsparingly
• DonotconfusewithEssentialPerformance
• IntendedasacompaniontoIEC60601-1-2,4th Ed.
• Immunityonly– noemissionsrequirements
• Pass/FailcriteriamaybemorestringentthanspecifiedinIEC60601-1-2,4th Edition
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IEC TR 60601-4-2:2016
• Pass/Failcriteriaisbasedon“Performance”
• EssentialPerformanceandBasicSafetyisnotrelevant
• ESDTestProcedureforconnectorsismodified
• WarningsymbolforESDisallowed(notallowedinIEC60601-1-2,4th Edition)
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IEC TR 60601-4-2:2016
ConcurrenttestingwithsafetytestingofIEC60601-1-2ispossibleif:
• Sametestsetup• Samemodesofoperation
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IEC TR 60601-4-2:2016
Difficulty=TestLevelsxFailureCriteria
ImmunityCompliance
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IEC TR 60601-4-2:2016
PerformanceCriteria
A) TheME EQUIPMENT orME SYSTEM shouldcontinuetomeettheperformancecriteriaduringandafterthefollowingtests,withouttheneedforOPERATOR intervention.
B) TheME EQUIPMENT orME SYSTEM shouldcontinuetomeettheperformancecriteriaafterthefollowingtests,withouttheneedforoperatorintervention.
C) TheME EQUIPMENT orME SYSTEM shouldcontinuetomeettheperformancecriteriaafterthefollowingtests.Operatorinterventionisallowed.
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Performance Criteria by Test
56
Test PerformanceCriteria
ESD B
Radiated Immunity A
EFT/Burst B
Surge B
Conducted Immunity A
Magnetic Immunity A
VoltageDips B/C
Voltage Interrupts C
Close FieldProximity A
Surge – (12VDCPowered) B
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Pass/Failure Criteria Comparison
57
EUTResponse IEC60601-1-24TH Edition*
IECTR60601-4-21st Edition**
Shuts Off/LatchUp Pass Fail
CatastrophicFailure Pass Fail
FalseAlarms Pass Fail
Performance Anomalies DependsonEP Fail
*AssumesEssentialPerformance&BasicSafetyismaintained**Assumesperformancedegradationbeyondmanufacturesspecifications
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Phenomenon IECTR60601-4-2:1st Edition
IEC60601-1-2:4th Edition
Prof.HealthcareEnvironment
HomeHealthcareEnvironment
ESD8kVAirDischarge(max.)4kVContactDischarge
CriteriaB
15kVAirDischarge(max.)8kVContactDischarge
EFT/Burst
1kV- ACMains500V- I/OPorts
5kHzor100kHzPRRCriteriaB
2kVACMains1kVI/OPorts100kHzPRR
Surges(ACMains)
2kVCriteriaB
2kV
Comparison of Immunity Test Levels
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Phenomenon IEC60601-4-2:1stEdition
IEC60601-1-2:4th Edition
Prof.HealthcareEnvironment
HomeHealthcareEnvironment
Magnetic Immunity(50/60Hz)
3A/MCriteriaB
30A/M
ConductedImmunity3V(0.15- 80MHz)
CriteriaA
3V(0.15- 80MHz)
6V(ISMBands)
3V(0.15- 80MHz)
6V(ISM+Amateur)
VoltageDips&Interrupts
• UT =0%,0.5cycle(0,&180°)
• UT=0%;1cycle UT=70%;25/30cycles(@0degrees)
• UT =0%;250/300cycle
• CriteriaB/C
• UT=0%,0.5cycle(0,45,90,135,180,225,270and315°)
• UT= 0%;1cycle UT=70%;25/30cycles(@0degrees)
• UT=0%;250/300cycle
Comparison of Immunity Test Levels (cont.)
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Phenomenon IECTR60601-4-2:1st Edition
IEC60601-1-2:4th Edition
Prof.HealthcareEnvironment
HomeHealthcareEnvironment
RadiatedImmunity
3V/m
80MHz– 2.7GHz
80%@1kHzAMModulation
3V/m
80MHz– 2.7GHz
80%@1kHzAMModulation
10V/m
80MHz– 2.7GHz
80%@1kHzAMModulation
ProximityFieldfromWirelessTransmitters
3V/mto9V/m15specific frequencies
9V/mto28V/m15specific frequencies
Comparison of Immunity Test Levels (cont.)
60
CriteriaA
CriteriaA
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Phenomenon IECTR60601-4-2:1st Edition
IEC60601-1-2:4th Edition
Prof.HealthcareEnvironment
HomeHealthcareEnvironment
Surges12VDCPowered
PerISO 7637-2:2011,5.6 N/A PerISO 7637-2:2011
Comparison of Immunity Test Levels (cont.)
61
CriteriaA
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TestFrequency(MHz)
TestLevel(Volts/meter)
IEC TR60601-4-2,1st IEC60601-1-2,4th
385 6 27
450 9 28
710,745,780 3 9
810,870,930 9 28
1720,1845,1970 9 28
2450 9 28
5240,5500,5785 6 9
Close Field Proximity Test Levels
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IEC TR 60601-4-2 Summary
63
• IntendedasacompaniontoIEC60601-1-2
• CanbeusedtoestablishEMCperformancerequirements
• BasedonperformancenotEssentialPerformance
• Pass/FailcriteriamaybemorestringentthanIEC60601-1-2
• ESDtestprocedureforconnectorsdiffersfromIEC60601-1-2
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The End
ThankYou!
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Darryl P. Ray
• Darryl Ray is the founder and Principal Consultant for Darryl Ray EMC Consulting. Hehas more than 40 years EMC experience working in the medical device, ITE anddefense industries.
• He received a Bachelors of Engineering Technology degree from Wayne StateUniversity in Detroit, Michigan.
• He has performed engineering design testing and troubleshooting on over 100products.
• He has built 9 EMC labs including numerous anechoic chambers. He has authoredseveral papers for past IEEE EMC symposiums.
• He is a Senior Member of the IEEE and former chair of the IEEE Santa Clara ValleyEMC chapter.
• He is an active member of IEC TC62 SC 62A, Maintenance Team 23 pertaining to thedevelopment of IEC 60601-1-2. He is also a member of the US national committeesfor CISPR 11, 22, 24, 32 and 35.
• He is an iNarte Certified Master EMC Design Engineer.
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Darryl P. Ray EMC Consulting, LLC• EMCDesign&Troubleshooting
• EMCTesting&Documentation
• RiskAnalysis
• EMCStandards
• EMCRegulatoryEngagement&Support
• MedicalDeviceEMCLabeling
• Training
• EMCLabDesign,ConstructionOversightandSetup
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