Workshop 4
IEC 60601-1-2, 4th Edition
Darryl P. Ray
PrincipalConsultant
DarrylRayEMCConsulting, LLC
Carlsbad, CA
[email protected]
+1-925-487-0072
www.dray-emc.com
APECConference2016LongBeach,CA- OverviewofIEC60601-1-24thEdition- Copyright2016DarrylRayEMCConsulting,LLC
APECConference2016LongBeach,CA- OverviewofIEC60601-1-24thEdition- Copyright2016DarrylRayEMCConsulting,LLC
Relevance to Power
• IEC60601-1-2isforMedicalEquipmentandMedicalSystems
Only
• Thisstandarddoesnotapplytosub-systems
• ManyoftheEMCtestsarerelatedtothepowerports
power
APECConference2016LongBeach,CA- OverviewofIEC60601-1-24thEdition- Copyright2016DarrylRayEMCConsulting,LLC
Essential Performance
• DealswithSafety performance;
(FreedomFromunacceptablerisk)
• DefinedBy:
• IEC60601-1Edition3.1
• IEC/ISO80601-2-X
• ManufacturesmaydefineusingRiskAnalysis
• Relevance:ImmunityacceptancecriteriaislinkedtoEssential
PerformanceandBasicSafety
APECConference2016LongBeach,CA- OverviewofIEC60601-1-24thEdition- Copyright2016DarrylRayEMCConsulting,LLC
Essential Performance
FromIEC60601-1:2005+A1:2012
3.27EssentialPerformance
performanceofaclinicalfunction,otherthanthatrelatedto
basicsafetywherelossordegradationbeyondthelimits
specifiedbythemanufacturerresultsinanunacceptablerisk
APECConference2016LongBeach,CA- OverviewofIEC60601-1-24thEdition- Copyright2016DarrylRayEMCConsulting,LLC
Basic Safety
FromIEC60601-1:2005+A1:2012
3.10BasicSafety
freedomfromunacceptableriskdirectlycausedbyphysical
hazardswhenmeequipmentisusedundernormalconditionand
singlefaultcondition
APECConference2016LongBeach,CA- OverviewofIEC60601-1-24thEdition- Copyright2016DarrylRayEMCConsulting,LLC
The Environment
Requirementsnowbasedonthreeuse environments;
• ProfessionalHealthcare
(hospital&smallclinic)
• HomeHealthcare
(mostlocationsoutsidethehospital/smallclinic)
• Special
(determinedonacasebycasebasis)
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Immunity Testing
• Immunitypass/failcriteriaisbasedonEssentialPerformance
andBasicSafetyonly
• Specificfailureattributesfrom3rd editioneliminated
• Immunity levelsarebasedonuselocation
(notthedevicetype)
APECConference2016LongBeach,CA- OverviewofIEC60601-1-24thEdition- Copyright2016DarrylRayEMCConsulting,LLC
Immunity Testing
• Higherimmunitylevelsinsomeinstances
• Standbymodeshouldbeconsidered
• ESD;
• IncreasedESDtestlevels
• ModifiedESDtestmethodonconnectors
APECConference2016LongBeach,CA- OverviewofIEC60601-1-24thEdition- Copyright2016DarrylRayEMCConsulting,LLC
Immunity Testing
• Newtest:CloseField Proximity
• 15specifictestfrequencies
• 9V/mto28V/m
• Mostlypulsemodulations
• Newtest:
Surgefordevicesconnectedto12Vvehiclepower
power
APECConference2016LongBeach,CA- OverviewofIEC60601-1-24thEdition- Copyright2016DarrylRayEMCConsulting,LLC
Immunity
• Conductedimmunitylevelsincreasedinsomecases
• ModifiedVoltageDips&Interruptstesting
power
• MagneticImmunitytestlevelssignificantlyincreased
• ArtificialHandtestingrequirementsclarified
APECConference2016LongBeach,CA- OverviewofIEC60601-1-24thEdition- Copyright2016DarrylRayEMCConsulting,LLC
References to Other Standards
Standard
References
IEC60601-1-2,3rd Edition
Undated
IEC60601-1-2,4th Edition
Dated
UndatedReference =Thecurrentversioninpublication,nograndfathering
APECConference2016LongBeach,CA- OverviewofIEC60601-1-24thEdition- Copyright2016DarrylRayEMCConsulting,LLC
Comparison of Emissions Limits
Phenomenon
IEC60601-1-2:
3rd Edition
power
Conducted &
Radiated Emissions
IEC60601-1-2:4th Edition
Prof.Healthcare
Environment
HomeHealthcare
Environment
CISPR 11, Edition 6.1
CISPR 11, Edition 5.1
(sample size implications)
power
Harmonics
IEC 61000-3-2
Class A
IEC 61000-3-2
Class A
power
Flicker
IEC 61000-3-3
IEC 61000-3-2
Bold = Changes From the 3rd edition
APECConference2016LongBeach,CA- OverviewofIEC60601-1-24thEdition- Copyright2016DarrylRayEMCConsulting,LLC
Comparison of Immunity Levels
power
power
IEC60601-1-2:4th Edition
Phenomenon
IEC60601-1-2:
3rd Edition
ESD
8 kV Air Discharge (max.)
6 kV Contact Discharge
15 kV Air Discharge (max.)
8 kV Contact Discharge
EFT/Burst
2 kV - AC Mains
1 kV - I/O Ports
5 kHz or 100 kHz PRR
2 kV AC Mains
1 kV I/O Ports
100 kHz PRR
Surges
(AC Mains)
2 kV
2 kV
Prof.Healthcare
Environment
HomeHealthcare
Environment
Bold = Changes From the 3rd edition
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Comparison of Immunity Levels (cont.)
Phenomenon
IEC60601-1-2:
3rd Edition
MagneticImmunity
(50/60Hz)
3A/M
3V(0.15- 80MHz)
power
ConductedImmunity
10VISMBands
(LifeSupport)
• UT <5%,0.5periods
power
VoltageDips&
Interrupts
• UT =40%,5periods
• UT =70%,25periods
• UT <5%,5seconds
IEC60601-1-2:4th Edition
Prof.Healthcare
Environment
HomeHealthcare
Environment
30A/M
3V(0.15- 80MHz)
3V(0.15- 80MHz)
6V(ISMBands)
6V (ISM +Amateur)
• UT =0%,0.5cycle
(0,45, 90,135,180,225,270and315°)
• UT = 0%;1cycleUT =70%;25/30cycles
(@0degrees)
• UT =0%;250/300cycle
Bold = Changes From the 3rd edition
APECConference2016LongBeach,CA- OverviewofIEC60601-1-24thEdition- Copyright2016DarrylRayEMCConsulting,LLC
Comparison of Immunity Levels (cont.)
Phenomenon
RadiatedImmunity
ProximityField
fromWireless
Transmitters
(NewTest)
IEC60601-1-2:
3rd Edition
IEC60601-1-2:4th Edition
Prof.Healthcare
Environment
HomeHealthcare
Environment
3V/m- NonLifeSupport
10V/m- LifeSupport
3V/m
10V/m
80MHz– 2.5GHz
80MHz– 2.7GHz
80MHz– 2.7GHz
80%@2Hz(or1kHz)
AMModulation
80%@1kHz
AMModulation
80%@1kHz
AMModulation
N/A
9V/mto28V/m
15specificfrequencies
Bold=ChangesFromthe3rd edition
APECConference2016LongBeach,CA- OverviewofIEC60601-1-24thEdition- Copyright2016DarrylRayEMCConsulting,LLC
Comparison of Immunity Levels (cont.)
power
Phenomenon
IEC60601-1-2:
3rd Edition
Electrical Transients Vehicle
12VoltPowered
(NewTest)
N/A
IEC60601-1-2:4th Edition
Prof.Healthcare
Environment
HomeHealthcare
Environment
N/A
ISO7637-2
Pulses- 600Vmax.
Bold=ChangesFromthe3rd edition
APECConference2016LongBeach,CA- OverviewofIEC60601-1-24thEdition- Copyright2016DarrylRayEMCConsulting,LLC
3rd Edition vs. 4th Edition
Doescompliancetothe4th Edition
=
compliancetothe3rd Edition?
APECConference2016LongBeach,CA- OverviewofIEC60601-1-24thEdition- Copyright2016DarrylRayEMCConsulting,LLC
When Do We Have to Comply with the 4th Edition?
United States
Legacy Devices;
Never*
European Union
OtherRegions
Dec31,2018**
Varies With;
TheCountry***
Part2Standards
NewSubmittals;
April,2017
Notes:
*
PerFDApredicatescheme(substantialequivalence)
** DatespublishedintheOJarepending
*** Somecountriesmaynotacceptthe4th edition
APECConference2016LongBeach,CA- OverviewofIEC60601-1-24thEdition- Copyright2016DarrylRayEMCConsulting,LLC
TheEnd– ThankYou!
Questions?
APECConference2016LongBeach,CA- OverviewofIEC60601-1-24thEdition- Copyright2016DarrylRayEMCConsulting,LLC