Infineon IKD03N60RF Igbt with integrated diode in packages offering space saving advantage Datasheet

IGBT
IGBTwithintegrateddiodeinpackagesofferingspacesavingadvantage
IKD03N60RF
TRENCHSTOPTMRC-Seriesforhardswitchingapplicationsupto30kHz
Datasheet
IndustrialPowerControl
IKD03N60RF
TRENCHSTOPTMRC-DrivesFastSeries
IGBTwithintegrateddiodeinpackagesofferingspacesavingadvantage
Features:
C
TRENCHSTOPTMReverseConducting(RC)technologyfor600V
applicationsoffering
•OptimizedEon,EoffandQrrforlowswitchinglosses
•Operatingrangeof4to30kHz
•SmoothswitchingperformanceleadingtolowEMIlevels
•Verytightparameterdistribution
•Maximumjunctiontemperature175°C
•Shortcircuitcapabilityof5µs
•Bestinclasscurrentversuspackagesizeperformance
•QualifiedaccordingtoJEDECfortargetapplications
•Pb-freeleadplating;RoHScompliant(soldertemperature
260°C,MSL1)
G
E
C
CompleteproductspectrumandPSpiceModels:
http://www.infineon.com/igbt/
G
E
Applications:
Domesticandindustrialdrives:
•Compressors
•Pumps
•Fans
KeyPerformanceandPackageParameters
Type
IKD03N60RF
VCE
IC
VCEsat,Tvj=25°C
Tvjmax
Marking
Package
600V
2.5A
2.2V
175°C
K03R60F
PG-TO252-3
2
Rev.2.5,2014-03-12
IKD03N60RF
TRENCHSTOPTMRC-DrivesFastSeries
TableofContents
Description . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2
Table of Contents . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3
Maximum ratings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4
Thermal Resistance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4
Electrical Characteristics . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
Electrical Characteristics diagrams . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8
Package Drawing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .15
Testing Conditions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .16
Revision History . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .17
Disclaimer . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .17
3
Rev.2.5,2014-03-12
IKD03N60RF
TRENCHSTOPTMRC-DrivesFastSeries
Maximumratings
Parameter
Symbol
Value
Unit
Collector-emittervoltage,Tvj≥25°C
VCE
600
V
DCcollectorcurrent,limitedbyTvjmax
TC=25°C
TC=100°C
IC
5.0
2.5
A
Pulsedcollectorcurrent,tplimitedbyTvjmax
ICpuls
7.5
A
Turn off safe operating area
VCE≤600V,Tvj≤175°C,tp=1µs
-
7.5
A
Diodeforwardcurrent,limitedbyTvjmax
TC=25°C
TC=100°C
IF
5.0
2.5
A
Diodepulsedcurrent,tplimitedbyTvjmax
IFpuls
7.5
A
Gate-emitter voltage
VGE
±20
V
Short circuit withstand time
VGE=15.0V,VCC≤400V
Allowed number of short circuits < 1000
Time between short circuits: ≥ 1.0s
Tvj=150°C
tSC
PowerdissipationTC=25°C
Ptot
53.6
W
Operating junction temperature
Tvj
-40...+175
°C
Storage temperature
Tstg
-55...+150
°C
µs
5
Soldering temperature,
reflow soldering (MSL1 according to JEDEC J-STA-020)
°C
260
ThermalResistance
Parameter
Characteristic
Symbol Conditions
Max.Value
Unit
IGBT thermal resistance,1)
junction - case
Rth(j-c)
2.80
K/W
Diode thermal resistance,2)
junction - case
Rth(j-c)
6.80
K/W
Thermal resistance, min. footprint
junction - ambient
Rth(j-a)
75
K/W
Thermal resistance, 6cm² Cu on
PCB
junction - ambient
Rth(j-a)
50
K/W
1)
2)
Rth/Zth based on single cooling pulse. Please be aware that a correct Rth measurement of the IGBT, is not possible using a thermocouple.
Rth/Zth based on single cooling pulse. Please be aware that a correct Rth measurement of the Diode, is not possible using a thermocouple.
4
Rev.2.5,2014-03-12
IKD03N60RF
TRENCHSTOPTMRC-DrivesFastSeries
ElectricalCharacteristic,atTvj=25°C,unlessotherwisespecified
Parameter
Symbol Conditions
Value
Unit
min.
typ.
max.
600
-
-
V
VGE=15.0V,IC=2.5A
Tvj=25°C
Tvj=175°C
-
2.20
2.30
2.50
-
V
-
2.10
2.00
2.40
-
V
4.3
5.0
5.7
V
VCE=600V,VGE=0V
Tvj=25°C
Tvj=175°C
-
-
StaticCharacteristic
Collector-emitter breakdown voltage V(BR)CES VGE=0V,IC=0.20mA
Collector-emitter saturation voltage VCEsat
Diode forward voltage
VF
VGE=0V,IF=2.5A
Tvj=25°C
Tvj=175°C
Gate-emitter threshold voltage
VGE(th)
IC=0.05mA,VCE=VGE
Zero gate voltage collector current1) ICES
40.0 µA
1000.0
Gate-emitter leakage current
IGES
VCE=0V,VGE=20V
-
-
100
nA
Transconductance
gfs
VCE=20V,IC=2.5A
-
1.3
-
S
Integrated gate resistor
rG
Ω
none
ElectricalCharacteristic,atTvj=25°C,unlessotherwisespecified
Parameter
Symbol Conditions
Value
Unit
min.
typ.
max.
-
200
-
-
13
-
-
7
-
-
17.1
-
nC
-
7.0
-
nH
-
A
DynamicCharacteristic
Input capacitance
Cies
Output capacitance
Coes
Reverse transfer capacitance
Cres
Gate charge
QG
Internal emitter inductance
measured 5mm (0.197 in.) from
case
LE
Short circuit collector current
Max. 1000 short circuits
IC(SC)
Time between short circuits: ≥ 1.0s
1)
VCE=25V,VGE=0V,f=1MHz
VCC=480V,IC=2.5A,
VGE=15V
VGE=15.0V,VCC≤400V,
tSC≤5µs
Tvj=25°C
-
pF
23
Not subject to production test - verified by design/characterization
5
Rev.2.5,2014-03-12
IKD03N60RF
TRENCHSTOPTMRC-DrivesFastSeries
SwitchingCharacteristic,InductiveLoad
Parameter
Symbol Conditions
Value
Unit
min.
typ.
max.
-
10
-
ns
-
8
-
ns
-
128
-
ns
-
93
-
ns
-
0.05
-
mJ
IGBTCharacteristic,atTvj=25°C
Turn-on delay time
td(on)
Rise time
tr
Turn-off delay time
td(off)
Fall time
tf
Turn-on energy
Eon
Turn-off energy
Eoff
-
0.04
-
mJ
Total switching energy
Ets
-
0.09
-
mJ
-
31
-
ns
-
0.06
-
µC
-
3.8
-
A
-
-196
-
A/µs
Tvj=25°C,
VCC=400V,IC=2.5A,
VGE=0.0/15.0V,
rG=68.0Ω,Lσ=60nH,
Cσ=40pF
Lσ,CσfromFig.E
DiodeCharacteristic,atTvj=25°C
Diode reverse recovery time
trr
Diode reverse recovery charge
Qrr
Diode peak reverse recovery current Irrm
Diode peak rate of fall of reverse
recoverycurrentduringtb
Tvj=25°C,
VR=400V,
IF=2.5A,
diF/dt=470A/µs
dirr/dt
SwitchingCharacteristic,InductiveLoad
Parameter
Symbol Conditions
Value
Unit
min.
typ.
max.
-
9
-
ns
-
9
-
ns
-
142
-
ns
-
123
-
ns
-
0.08
-
mJ
IGBTCharacteristic,atTvj=175°C
Turn-on delay time
td(on)
Rise time
tr
Turn-off delay time
td(off)
Fall time
tf
Turn-on energy
Eon
Turn-off energy
Eoff
-
0.06
-
mJ
Total switching energy
Ets
-
0.14
-
mJ
-
66
-
ns
-
0.19
-
µC
-
6.2
-
A
-
-125
-
A/µs
Tvj=175°C,
VCC=400V,IC=2.5A,
VGE=0.0/15.0V,
rG=68.0Ω,Lσ=60nH,
Cσ=40pF
Lσ,CσfromFig.E
DiodeCharacteristic,atTvj=175°C
Diode reverse recovery time
trr
Diode reverse recovery charge
Qrr
Diode peak reverse recovery current Irrm
Diode peak rate of fall of reverse
recoverycurrentduringtb
Tvj=175°C,
VR=400V,
IF=2.5A,
diF/dt=470A/µs
dirr/dt
6
Rev.2.5,2014-03-12
IKD03N60RF
TRENCHSTOPTMRC-DrivesFastSeries
2.5
10
IC,COLLECTORCURRENT[A]
IC,COLLECTORCURRENT[A]
2.0
1.5
1.0
tp=1µs
10µs
1
20µs
50µs
100µs
500µs
0.5
0.0
DC
0.1
1
10
0.1
100
1
f,SWITCHINGFREQUENCY[kHz]
100
1000
Figure 2. Forwardbiassafeoperatingarea
(D=0,TC=25°C,Tvj≤175°C;VGE=15V)
60
6
50
5
IC,COLLECTORCURRENT[A]
Ptot,POWERDISSIPATION[W]
Figure 1. Collectorcurrentasafunctionofswitching
frequency
(Tvj≤175°C,Ta=55°C,D=0.5,VCE=400V,
VGE=15/0V,rG=68Ω,PCBmounting,6cm2
Cu, Ptot=2,4W)
40
30
20
10
0
10
VCE,COLLECTOR-EMITTERVOLTAGE[V]
4
3
2
1
25
50
75
100
125
150
0
175
TC,CASETEMPERATURE[°C]
0
25
50
75
100
125
150
175
TC,CASETEMPERATURE[°C]
Figure 3. Powerdissipationasafunctionofcase
temperature
(Tvj≤175°C)
Figure 4. Collectorcurrentasafunctionofcase
temperature
(VGE≥15V,Tvj≤175°C)
7
Rev.2.5,2014-03-12
IKD03N60RF
TRENCHSTOPTMRC-DrivesFastSeries
9
9
VGE=20V
8
17V
15V
13V
6
11V
9V
5
7V
4
3
15V
13V
6
4
3
1
1
1
2
3
0
4
9V
7V
2
0
11V
5
2
0
17V
7
IC,COLLECTORCURRENT[A]
7
IC,COLLECTORCURRENT[A]
VGE=20V
8
0
VCE,COLLECTOR-EMITTERVOLTAGE[V]
Figure 5. Typicaloutputcharacteristic
(Tvj=25°C)
3
4
4.0
Tj=25°C
Tj=175°C
VCEsat,COLLECTOR-EMITTERSATURATION[V]
8
7
IC,COLLECTORCURRENT[A]
2
Figure 6. Typicaloutputcharacteristic
(Tvj=175°C)
9
6
5
4
3
2
1
0
1
VCE,COLLECTOR-EMITTERVOLTAGE[V]
4
6
8
10
12
3.5
3.0
2.5
2.0
1.5
1.0
0.5
0.0
14
VGE,GATE-EMITTERVOLTAGE[V]
IC=0.6A
IC=1A
IC=2.5A
IC=5A
0
25
50
75
100
125
150
175
Tvj,JUNCTIONTEMPERATURE[°C]
Figure 7. Typicaltransfercharacteristic
(VCE=10V)
Figure 8. Typicalcollector-emittersaturationvoltageas
afunctionofjunctiontemperature
(VGE=15V)
8
Rev.2.5,2014-03-12
IKD03N60RF
TRENCHSTOPTMRC-DrivesFastSeries
td(off)
tf
td(on)
tr
100
t,SWITCHINGTIMES[ns]
t,SWITCHINGTIMES[ns]
100
td(off)
tf
td(on)
tr
10
1
0.0
0.5
1.0
1.5
2.0
2.5
3.0
3.5
10
1
4.0
10
20
30
IC,COLLECTORCURRENT[A]
40
50
60
70
80
90 100 110 120
rG,GATERESISTOR[Ω]
Figure 9. Typicalswitchingtimesasafunctionof
collectorcurrent
(inductiveload,Tvj=175°C,VCE=400V,
VGE=15/0V,rG=68Ω,Dynamictestcircuitin
Figure E)
Figure 10. Typicalswitchingtimesasafunctionofgate
resistor
(inductiveload,Tvj=175°C,VCE=400V,
VGE=15/0V,IC=2,5A,Dynamictestcircuitin
Figure E)
7
VGE(th),GATE-EMITTERTHRESHOLDVOLTAGE[V]
td(off)
tf
td(on)
tr
t,SWITCHINGTIMES[ns]
100
10
1
25
50
75
100
125
150
6
5
4
3
2
1
175
Tvj,JUNCTIONTEMPERATURE[°C]
Figure 11. Typicalswitchingtimesasafunctionof
junctiontemperature
(inductiveload,VCE=400V,VGE=15/0V,
IC=2,5A,rG=68Ω,Dynamictestcircuitin
Figure E)
typ.
min.
max.
25
50
75
100
125
150
175
Tvj,JUNCTIONTEMPERATURE[°C]
Figure 12. Gate-emitterthresholdvoltageasafunction
ofjunctiontemperature
(IC=0,05mA)
9
Rev.2.5,2014-03-12
IKD03N60RF
TRENCHSTOPTMRC-DrivesFastSeries
0.25
0.20
Eoff
Eon
Ets
0.18
E,SWITCHINGENERGYLOSSES[mJ]
E,SWITCHINGENERGYLOSSES[mJ]
Eoff
Eon
Ets
0.20
0.15
0.10
0.05
0.16
0.14
0.12
0.10
0.08
0.06
0.04
0.02
0.00
0.0
0.5
1.0
1.5
2.0
2.5
3.0
3.5
0.00
4.0
10
20
30
IC,COLLECTORCURRENT[A]
Figure 13. Typicalswitchingenergylossesasa
functionofcollectorcurrent
(inductiveload,Tvj=175°C,VCE=400V,
VGE=15/0V,rG=68Ω,Dynamictestcircuitin
Figure E)
60
70
80
90 100 110 120
0.18
Eoff
Eon
Ets
0.16
E,SWITCHINGENERGYLOSSES[mJ]
0.14
E,SWITCHINGENERGYLOSSES[mJ]
50
Figure 14. Typicalswitchingenergylossesasa
functionofgateresistor
(inductiveload,Tvj=175°C,VCE=400V,
VGE=15/0V,IC=2,5A,Dynamictestcircuitin
Figure E)
0.16
0.12
0.10
0.08
0.06
0.04
0.02
0.00
40
rG,GATERESISTOR[Ω]
Eoff
Eon
Ets
0.14
0.12
0.10
0.08
0.06
0.04
0.02
25
50
75
100
125
150
0.00
200
175
Tvj,JUNCTIONTEMPERATURE[°C]
Figure 15. Typicalswitchingenergylossesasa
functionofjunctiontemperature
(inductiveload,VCE=400V,VGE=15/0V,
IC=2,5A,rG=68Ω,Dynamictestcircuitin
Figure E)
250
300
350
400
450
500
VCE,COLLECTOR-EMITTERVOLTAGE[V]
10
Figure 16. Typicalswitchingenergylossesasa
functionofcollectoremittervoltage
(inductiveload,Tvj=175°C,VGE=15/0V,
IC=2,5A,rG=68Ω,Dynamictestcircuitin
Figure E)
Rev.2.5,2014-03-12
IKD03N60RF
TRENCHSTOPTMRC-DrivesFastSeries
18
1000
120V
480V
14
C,CAPACITANCE[pF]
VGE,GATE-EMITTERVOLTAGE[V]
16
Cies
Coes
Cres
12
10
8
6
100
10
4
2
0
0
2
4
6
8
10
12
14
16
1
18
0
QGE,GATECHARGE[nC]
Figure 17. Typicalgatecharge
(IC=2,5A)
10
15
20
25
30
Figure 18. Typicalcapacitanceasafunctionof
collector-emittervoltage
(VGE=0V,f=1MHz)
50
12
45
tSC,SHORTCIRCUITWITHSTANDTIME[µs]
IC(SC),SHORTCIRCUITCOLLECTORCURRENT[A]
5
VCE,COLLECTOR-EMITTERVOLTAGE[V]
40
35
30
25
20
15
10
10
8
6
4
2
5
0
12
13
14
15
16
17
18
19
0
20
VGE,GATE-EMITTERVOLTAGE[V]
10
11
12
13
14
15
16
17
18
19
VGE,GATE-EMITTERVOLTAGE[V]
Figure 19. Typicalshortcircuitcollectorcurrentasa
functionofgate-emittervoltage
(VCE≤400V,startatTvj=25°C)
Figure 20. Shortcircuitwithstandtimeasafunctionof
gate-emittervoltage
(VCE≤400V,startatTvj=150°C)
11
Rev.2.5,2014-03-12
IKD03N60RF
Zth(j-c),TRANSIENTTHERMALIMPEDANCE[K/W]
Zth(j-c),TRANSIENTTHERMALIMPEDANCE[K/W]
TRENCHSTOPTMRC-DrivesFastSeries
1
D=0.5
0.2
0.1
0.05
0.02
0.01
0.1
single pulse
i:
1
2
3
4
5
6
7
ri[K/W]: 0.01575075 1.14785 1.341315 0.2371822 0.04191411 6.2E-3
2.2E-3
τi[s]:
1.2E-5
2.3E-4
1.1E-3
6.0E-3
0.04756135 0.2881606 1.246755
0.01
1E-7
1E-6
1E-5
1E-4
0.001
0.01
0.1
D=0.5
1
0.2
0.1
0.05
0.02
0.01
single pulse
0.1
i:
1
2
3
4
5
6
7
ri[K/W]: 0.6006593 4.018125 1.846211 0.2895592 0.04375384 6.0E-3
2.1E-3
τi[s]:
4.2E-5
1.9E-4
1.1E-3
6.1E-3
0.0484688 0.3013493 1.300555
0.01
1E-7
1
1E-6
tp,PULSEWIDTH[s]
0.001
0.01
0.1
1
Figure 22. Diodetransientthermalimpedanceasa
functionofpulsewidth2)(seepage4)
(D=tp/T)
80
0.20
Tj=25°C, IF = 2.5A
Tj=175°C, IF = 2.5A
0.18
Qrr,REVERSERECOVERYCHARGE[µC]
70
trr,REVERSERECOVERYTIME[ns]
1E-4
tp,PULSEWIDTH[s]
Figure 21. IGBTtransientthermalimpedanceasa
functionofpulsewidth1)(seepage4)
(D=tp/T)
60
50
40
30
20
10
0
400
1E-5
0.16
0.14
Tj=25°C, IF = 2.5A
Tj=175°C, IF = 2.5A
0.12
0.10
0.08
0.06
0.04
0.02
500
600
700
800
900
1000
diF/dt,DIODECURRENTSLOPE[A/µs]
0.00
400
500
600
700
800
900
1000
diF/dt,DIODECURRENTSLOPE[A/µs]
Figure 23. Typicalreverserecoverytimeasafunction
ofdiodecurrentslope
(VR=400V)
12
Figure 24. Typicalreverserecoverychargeasa
functionofdiodecurrentslope
(VR=400V)
Rev.2.5,2014-03-12
IKD03N60RF
TRENCHSTOPTMRC-DrivesFastSeries
10
0
Tj=25°C, IF = 2.5A
Tj=175°C, IF = 2.5A
Tj=25°C, IF = 2.5A
Tj=175°C, IF = 2.5A
-100
dIrr/dt,diodepeakrateoffallofIrr[A/µs]
Irr,REVERSERECOVERYCURRENT[A]
9
8
7
6
5
4
-200
-300
-400
-500
3
2
400
500
600
700
800
900
-600
400
1000
diF/dt,DIODECURRENTSLOPE[A/µs]
500
600
700
800
900
1000
diF/dt,DIODECURRENTSLOPE[A/µs]
Figure 25. Typicalreverserecoverycurrentasa
functionofdiodecurrentslope
(VR=400V)
Figure 26. Typicaldiodepeakrateoffallofreverse
recoverycurrentasafunctionofdiode
currentslope
(VR=400V)
9
2.8
Tj=25°C, VGE=0V
Tj=175°C, VGE=0V
8
2.6
2.4
VF,FORWARDVOLTAGE[V]
IF,FORWARDCURRENT[A]
7
6
5
4
3
2.2
2.0
1.8
1.6
2
1.4
1
1.2
0
0
1
2
3
1.0
4
VF,FORWARDVOLTAGE[V]
IF=0.6A
IF=1A
IF=2.5A
IF=5A
0
25
50
75
100
125
150
175
Tvj,JUNCTIONTEMPERATURE[°C]
Figure 27. Typicaldiodeforwardcurrentasafunction
offorwardvoltage
13
Figure 28. Typicaldiodeforwardvoltageasafunction
ofjunctiontemperature
Rev.2.5,2014-03-12
IKD03N60RF
TRENCHSTOPTMRC-DrivesFastSeries
PG - TO252 - 3
14
Rev.2.5,2014-03-12
IKD03N60RF
TRENCHSTOPTMRC-DrivesFastSeries
vGE(t)
90% VGE
a
a
b
b
t
iC(t)
90% IC
90% IC
10% IC
10% IC
t
vCE(t)
t
td(off)
tf
td(on)
t
tr
vGE(t)
90% VGE
10% VGE
t
iC(t)
2% IC
t
vCE(t)
2% VCE
t1
t2
t3
t4
t
15
Rev.2.5,2014-03-12
IKD03N60RF
TRENCHSTOPTMRC-DrivesFastSeries
RevisionHistory
IKD03N60RF
Revision:2014-03-12,Rev.2.5
Previous Revision
Revision
Date
Subjects (major changes since last revision)
1.1
2011-06-07
Preliminary Data sheet
2.2
2012-02-23
Final data sheet
2.3
2013-12-10
New value ICES max limit at 175°C
2.4
2014-02-26
Without PB free logo
2.5
2014-03-12
Storage temperature -55...+150°C
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©2014InfineonTechnologiesAG
AllRightsReserved.
LegalDisclaimer
Theinformationgiveninthisdocumentshallinnoeventberegardedasaguaranteeofconditionsorcharacteristics.
Withrespecttoanyexamplesorhintsgivenherein,anytypicalvaluesstatedhereinand/oranyinformationregardingthe
applicationofthedevice,InfineonTechnologiesherebydisclaimsanyandallwarrantiesandliabilitiesofanykind,
includingwithoutlimitation,warrantiesofnon-infringementofintellectualpropertyrightsofanythirdparty.
Information
Forfurtherinformationontechnology,deliverytermsandconditionsandprices,pleasecontactthenearestInfineon
TechnologiesOffice(www.infineon.com).
Warnings
Duetotechnicalrequirements,componentsmaycontaindangeroussubstances.Forinformationonthetypesin
question,pleasecontactthenearestInfineonTechnologiesOffice.
TheInfineonTechnologiescomponentdescribedinthisDataSheetmaybeusedinlife-supportdevicesorsystems
and/orautomotive,aviationandaerospaceapplicationsorsystemsonlywiththeexpresswrittenapprovalofInfineon
Technologies,ifafailureofsuchcomponentscanreasonablybeexpectedtocausethefailureofthatlife-support,
automotive,aviationandaerospacedeviceorsystemortoaffectthesafetyoreffectivenessofthatdeviceorsystem.Life
supportdevicesorsystemsareintendedtobeimplantedinthehumanbodyortosupportand/ormaintainandsustain
and/orprotecthumanlife.Iftheyfail,itisreasonabletoassumethatthehealthoftheuserorotherpersonsmaybe
endangered.
16
Rev.2.5,2014-03-12
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