introduction to medical emc - ieee · 2017-12-15 · medical emc requirements • requirements are...

DarrylP.RayPrincipalConsultant

DarrylRayEMCConsulting,LLC

[email protected]

925-487-0072

www.dray-emc.com

1

Introduction to Medical EMC

Introduction toMedicalEMC,IEEESCVDec2017Copyright2017DarrylRayEMCConsulting,LLCdray-emc.com

Scope

Thispresentationfocuseson:

MedicalElectricalDevicesand

MedicalElectricalSystemsonly

2Introduction toMedicalEMC,IEEESCVDec2017Copyright2017DarrylRayEMCConsulting,LLCdray-emc.com

IEC 60601/80601 Series of Standards

• Safetystandards• Patient• Operator• Environment

• EssentialPerformancecovered

• Over80standards&growing

• 80601=JointIEC/ISOstandard


Medical Device Requirements Hierarchy

Precedence


Regulations

Particular StandardsDeviceSpecific (Vertical)

IEC/ISO80601-2-X

Collateral StandardsApplytoAllDevices(Horizontal)

IEC60601-1-X

Referenced Standards(e.g.IEC61000-4-X)

5

Requirements

60601-2-4

Particular requirements

Defibrillator/ monitors

60601-2-3


Short-wave therapy equipment

60601-2-2


HF surgical equipment

60601-2-1


Medical accelerators

Particularstandards

80+standards

Amendsthegeneralrequirementsforspecifictypesofequipmentandtakeprecedence!

60601-1-3General requirements



60601-1General requirements

GeneralStandardAppliestoallequipment


ISO Particular Standard Example – IEC 60601-2-54:2009

6 |Introduction toMedicalEMC,IEEESCVDec2017Copyright2017DarrylRayEMCConsulting,LLCdray-emc.com

Medical EMC Requirements

• RequirementsaregenerallyperIEC60601-1-2

• EN60601-1-2isequivalent

• Particularstandards(IEC80601-2-X)maymodifyimmunitylevelsandacceptancecriteria

• IEC60601-1-24th editionpublishedFebruary2014

7

What is Essential Performance (EP)?

Introduction toMedicalEMC,IEEESCVDec2017Copyright2017DarrylRayEMCConsulting,LLCdray-emc.com 8

• DealswithSafetyRelated Performance

devicecanbesusceptible butmuststaysafe

• DefinedBy:

• IEC/ISO80601-2-X(ifapplicable)• IEC60601-1Edition3.1(seecl3.27&4.3)• Manufacturemaybroadenthescope– Usingriskanalysis

• SomedeviceshavenoEssentialPerformance

• Relevance:ImmunityacceptancecriteriaislinkedtoEP

What is Essential Performance?


FromIEC60601-1:2005+A1:2012

Essential Performance - Example


FromIEC60601-2-37:2015

More on Essential Performance

11 |

• EMCSusceptibilitydoesnotalwaysequalfailure!

• EssentialPerformancecannotbe“compliedwith”

(mustbemaintained)

• TheRiskManagementFileshouldrelatetothedefinitionofEP

(entriesmuststateunacceptablerisk)

• ManytestlabsdonotunderstandEP


12 |IntroductiontoMedicalEMC,IEEESCVDec2017Copyright2017DarrylRayEMCConsulting,LLCdray-emc.com

3rd Editionhasbeenwithdrawn

Motivation

13

• Aimwastocreateasafety standardwithrespecttoEMdisturbances

• Drawbackswiththe3rdEdition;• BasicSafetyandEssentialPerformanceaspectshavenotbeen

adequatelyaddressed

• TestLevelsinthecurrentstandardarenearly20yearsold(NewEMenvironmentsunaccountedfor,e.g.cellphones)

• Mobiledeviceusagerestrictionsarenowgenerallyignored

• DevicesinthesameuselocationmeetdifferentimmunityLevels

IntroductiontoMedicalEMC,IEEESCVDec2017Copyright2017DarrylRayEMCConsulting,LLCdray-emc.com

The Real World!

PhotocourtesyofDr.DavidHTScott,DepartmentofAnesthetics,TheRoyalInfirmaryofEdinburgh,UnitedKingdom

14 14

4th Edition - General

Immunityrequirementsnowbasedonthreeuserenvironments

• ProfessionalHealthcare(hospital&smallclinic)

• HomeHealthcare(mostlocationsoutsidethehospital/smallclinic)

• Special(determinedonacase-by-casebasis)


Intended Use Locations Examples


4th Edition - General

• ACinputvoltagerequirementsclarified• Streamlinedtoonevoltage/frequency

(exception:VoltageDips&Interrupts)

• Regulatorsmayrequiretestingusingnationalvoltages

• TestingofI/Oports(SIP/SOPS)clarified

• ThePotentialEqualizationConductorTerminal(if applicable) mustbeconnectedduringtesting


Potential Equalization Conductor Terminal

Ref.IEC60601-1Edition3.1,Figure2


4th Edition - Emissions

• MustcomplywithCISPR11,IEC6100-3-2/3

• Standbymodeshouldbeconsidered

• RequirementsofCISPR14-1limitedtoswitchingdevicesandmotors

• RequirementsofCISPR15eliminated

• ITEequipmentmustmeetCISPR32(notCISPR22)

• X-Raygeneratorsallowed20dBrelaxation(intermittentmode)


4th Edition - Immunity

• Immunitypass/failcriteriaisbasedonEssentialPerformanceandBasicSafetyonly

• Specificfailureattributesfrom3rd editionarenolongerspecified

• Immunity testlevelsarebasedonuselocation(notthedevicetype)



• Higherimmunitytestlevelsinsomeinstances

• Standbymodeshouldbeconsidered

• ESD• IncreasedESDtestlevels

• ModifiedESDtestmethodonconnectors



• TransmitterExclusionBandeliminated(RadiatedImmunityOnly)

• TestingonDCinputportconditionallyrequired(PermanentCables>3m)

• Provisionaddedtoaddresstestsamplesdamagedduringtesting

• Twonewimmunitytestsadded

• CloseFieldProximity

• 12VDCSurge



• Conductedimmunitylevelsincreasedinsomecases

• ModifiedVoltageDips&Interruptstesting

• MagneticImmunitytestlevelssignificantlyincreased

• ArtificialHandtestingrequirementsclarified


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






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


Comparison of Immunity Test Levels (cont.)


PhenomenonIEC60601-1-2:3rd Edition




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


ProximityFieldfromWirelessTransmitters(NewTest)

N/A9V/mto28V/m

15specific frequencies




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






Electrical Transients -Vehicle

12VPowered(NewTest)

N/A N/A ISO7637-2Pulses– 600Vmax.


Comparison of Immunity Levels (cont.)


ESD Testing on Connectors

29

ConnectorShell DischargeRequirements ConnectorUsage

Metallic ContactDischargetoShellOnly INTENDEDUSE

NonMetallic• AirDischarge toShell• AirDischarge toPins(ifReachablebyTestFinger)

INTENDED& NORMALUSE


IntendedUse– ClinicalUseOnlyNormalUse– IntendedUsePlus Maintenance,StandbyMode,etc.

4th Edition – ESD Testing Example

30

RJ45EthernetConnector(Non-Metallic)



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?


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

4th Edition – Risk Management


Integration with Non Medical Equipment

• MustnotcompromisethesystemEssentialPerformanceandBasicSafety

• Non-medicalequipmentmustcomplywithapplicablestandards

• ITE(multimedia)mustcomplywithCISPR32(notCISPR22)

4th Edition


What’s the EUT?


ACPowerInput

LAN Port

ACPowerSource

PCwithDisplay,Printer,Keyboard&Mouse

LANPort

LANCable

ACPowerSource

MedicalDevice

SoldasanAccessory

Testing with Non Medical Devices Attached


Clause4.2

• non-MEEQUIPMENTusedinanMESYSTEMshallcomplywithIECandISOEMCstandardsapplicabletothatequipment;

• non-MEEQUIPMENTusedinanMESYSTEMforwhichtheintendedEMENVIRONMENTcouldresultinthelossofBASICSAFETYorESSENTIALPERFORMANCEoftheMESYSTEMduetothenon-MEEQUIPMENTshallbetestedaccordingtotherequirementsofthiscollateralstandard.

Is Non Medical Equipment Required to be Tested?

Introduction toMedicalEMC,IEEESCVDec2017Copyright2017DarrylRayEMCConsulting,LLCdray-emc.com 37 |

ForImmunitytesting,useRiskAnalysistodetermineifEP/BScouldbecompromised:

• Ifyes– testingisrequired

• Ifno– testingisnotrequired

• Ifunknown– testingisrequired


Thetestplancontentsareinformative

4th Edition – Documentation

39

• Labelingrequirementsmodified&partiallystreamlined–EMCtablesdeleted

• EMCtestplanrequired,recommendedcontent

• EMCtestreportrequired,minimumcontentdefined

• RiskManagement– numerousEMCconsiderationsrequired


Documentation

4th Edition - Documentation

• CISPR11ClassAemissionswarningstatement(textdiffersfromCISPR11)

• Labelingrequirementsmodified(EMCtablesdeleted- butmaystillbeusedifdesired)

• EMCtestplanrequired- recommendedcontent


4th Edition - Documentation

• EMCtestreportrequired- minimumcontentspecified

• Referencedstandards- dated referencesspecified

• CISPR11Edition5.1specified,Edition6.1published

• Riskmanagementprocess– numerousEMCconsiderationsrequired



• NoLongerRequired;

• Emissionscompliancetable

• Immunitycompliancetable

• Immunity(transients)compliancetable

• Separationdistancetable

• NoLongerAllowed;

• I/OPortESDexemption&marking


abbreviated

IEC 60601-1-2, 4th Edition - Labelling


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

46

4th edition versus 3rd Edition

Does Compliance to the 4th Editionconstitute compliance to 3rd Edition?

Answer: No Way !


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


What Does All This Mean?

IntroductiontoMedicalEMC,IEEESCVDec2017Copyright2017DarrylRayEMCConsulting,LLCdray-emc.com 48 |

• LegacyProducts- ToComplywiththe4th Edition(minimum):• RetestingisRequired;

• w/PotentialEqualizationConductorattached(if applicable)• EmissionsinStandbyMode• ModifiedImmunityPass/Failcriteria• ModifiedImmunityTestRequirementsperclause8• NewTests– CloseFieldProximity&VehicleSurge

• LabelingModifications

• RiskManagement– Additionstothefile

• NewDesigns– recommend4thEdition– butconsiderinternationalrequirements

IEC TR 60601-4-2:2016

• Initialplan– Includedin60601-1-2:2016- AnnexJ

• Deletedatthelastminute

• Separatestandalonedocument

• IECversiononly– NocorrespondingENplanned

• RegulatoryRequirement?


IEC TR 60601-4-2:2016

• Thisisarecommendation– theterm“shall”isusedsparingly

• DonotconfusewithEssentialPerformance

• IntendedasacompaniontoIEC60601-1-2,4th Ed.

• Immunityonly– noemissionsrequirements

• Pass/FailcriteriamaybemorestringentthanspecifiedinIEC60601-1-2,4th Edition


IEC TR 60601-4-2:2016

• Pass/Failcriteriaisbasedon“Performance”

• EssentialPerformanceandBasicSafetyisnotrelevant

• ESDTestProcedureforconnectorsismodified

• WarningsymbolforESDisallowed(notallowedinIEC60601-1-2,4th Edition)


IEC TR 60601-4-2:2016

ConcurrenttestingwithsafetytestingofIEC60601-1-2ispossibleif:

• Sametestsetup• Samemodesofoperation


IEC TR 60601-4-2:2016

Difficulty=TestLevelsxFailureCriteria

ImmunityCompliance


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.


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


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


Phenomenon IECTR60601-4-2:1st Edition




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


Phenomenon IEC60601-4-2:1stEdition




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







RadiatedImmunity

3V/m

80MHz– 2.7GHz


3V/m

80MHz– 2.7GHz


10V/m

80MHz– 2.7GHz


ProximityFieldfromWirelessTransmitters

3V/mto9V/m15specific frequencies

9V/mto28V/m15specific frequencies


60

CriteriaA

CriteriaA






Surges12VDCPowered

PerISO 7637-2:2011,5.6 N/A PerISO 7637-2:2011


61

CriteriaA


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


IEC TR 60601-4-2 Summary

63

• IntendedasacompaniontoIEC60601-1-2

• CanbeusedtoestablishEMCperformancerequirements

• BasedonperformancenotEssentialPerformance

• Pass/FailcriteriamaybemorestringentthanIEC60601-1-2

• ESDtestprocedureforconnectorsdiffersfromIEC60601-1-2


The End

ThankYou!

64 |Introduction toMedicalEMC,IEEESCVDec2017Copyright2017DarrylRayEMCConsulting,LLCdray-emc.com

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.


Darryl P. Ray EMC Consulting, LLC• EMCDesign&Troubleshooting

• EMCTesting&Documentation

• RiskAnalysis

• EMCStandards

• EMCRegulatoryEngagement&Support

• MedicalDeviceEMCLabeling

• Training

• EMCLabDesign,ConstructionOversightandSetup


introduction to medical emc - ieee · 2017-12-15 · medical emc requirements • requirements are...

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