IHW40N120R3FKSA1 [INFINEON]
Insulated Gate Bipolar Transistor, 80A I(C), 1200V V(BR)CES, N-Channel,;型号: | IHW40N120R3FKSA1 |
厂家: | Infineon |
描述: | Insulated Gate Bipolar Transistor, 80A I(C), 1200V V(BR)CES, N-Channel, 栅 |
文件: | 总15页 (文件大小:2176K) |
中文: | 中文翻译 | 下载: | 下载PDF数据表文档文件 |
InductionꢀHeatingꢀSeries
ReverseꢀconductingꢀIGBTꢀwithꢀmonolithicꢀbodyꢀdiode
IHW40N120R3
Datasheet
IndustrialꢀPowerꢀControl
IHW40N120R3
InductionꢀHeatingꢀSeries
ReverseꢀconductingꢀIGBTꢀwithꢀmonolithicꢀbodyꢀdiode
ꢀ
C
Features:
•ꢀPowerfulꢀmonolithicꢀbodyꢀdiodeꢀwithꢀlowꢀforwardꢀvoltageꢀ
ꢀꢀdesignedꢀforꢀsoftꢀcommutationꢀonly
•ꢀTRENCHSTOPTMꢀtechnologyꢀoffering:
ꢀꢀ-ꢀveryꢀtightꢀparameterꢀdistribution
ꢀꢀ-ꢀhighꢀruggedness,ꢀtemperatureꢀstableꢀbehavior
ꢀꢀ-ꢀlowꢀVCEsat
G
E
ꢀꢀ-ꢀeasyꢀparallelꢀswitchingꢀcapabilityꢀdueꢀtoꢀpositiveꢀ
ꢀꢀꢀꢀtemperatureꢀcoefficientꢀinꢀVCEsat
•ꢀLowꢀEMI
•ꢀQualifiedꢀaccordingꢀtoꢀJESD-022ꢀforꢀtargetꢀapplications
•ꢀPb-freeꢀleadꢀplating;ꢀRoHSꢀcompliant
•ꢀHalogenꢀfreeꢀ(accordingꢀtoꢀIECꢀ61249-2-21)
•ꢀCompleteꢀproductꢀspectrumꢀandꢀPSpiceꢀModels:ꢀ
ꢀꢀhttp://www.infineon.com/igbt/
G
Applications:
C
E
•ꢀInductiveꢀcookingꢀ
Packageꢀpinꢀdefinition:
•ꢀPinꢀ1ꢀ-ꢀgate
•ꢀPinꢀ2ꢀ&ꢀbacksideꢀ-ꢀcollector
•ꢀPinꢀ3ꢀ-ꢀemitter
KeyꢀPerformanceꢀandꢀPackageꢀParameters
Type
VCE
IC
VCEsat,ꢀTvj=25°C Tvjmax
1.55V 175°C
Marking
Package
IHW40N120R3
1200V
40A
H40R1203
PG-TO247-3
2
Rev.ꢀ2.1,ꢀꢀ2012-10-12
IHW40N120R3
InductionꢀHeatingꢀSeries
TableꢀofꢀContents
Description . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2
Table of Contents . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3
Maximum ratings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4
Thermal Resistance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4
Electrical Characteristics . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
Electrical Characteristics diagrams . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
Package Drawing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .13
Testing Conditions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .14
Revision History . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .15
Disclaimer . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .15
3
Rev.ꢀ2.1,ꢀꢀ2012-10-12
IHW40N120R3
InductionꢀHeatingꢀSeries
Maximumꢀratings
Parameter
Symbol
Value
Unit
Collector-emitter voltage
VCE
1200
V
DCꢀcollectorꢀcurrent,ꢀlimitedꢀbyꢀTvjmax
TCꢀ=ꢀ25°C
TCꢀ=ꢀ100°C
IC
80.0
40.0
A
Pulsedꢀcollectorꢀcurrent,ꢀtpꢀlimitedꢀbyꢀTvjmax
ICpuls
120.0
120.0
A
A
TurnꢀoffꢀsafeꢀoperatingꢀareaꢀVCEꢀ≤ꢀ1200V,ꢀTvjꢀ≤ꢀ175°C
-
Diodeꢀforwardꢀcurrent,ꢀlimitedꢀbyꢀTvjmax
TCꢀ=ꢀ25°C
TCꢀ=ꢀ100°C
IF
80.0
40.0
A
Diodeꢀpulsedꢀcurrent,ꢀtpꢀlimitedꢀbyꢀTvjmax
IFpuls
VGE
120.0
A
V
Gate-emitter voltage
TransientꢀGate-emitterꢀvoltageꢀ(tpꢀ≤ꢀ10µs,ꢀDꢀ<ꢀ0.010)
±20
±25
PowerꢀdissipationꢀTCꢀ=ꢀ25°C
PowerꢀdissipationꢀTCꢀ=ꢀ100°C
429.0
215.0
Ptot
W
Operating junction temperature
Storage temperature
Tvj
-40...+175
-55...+175
°C
°C
Tstg
Soldering temperature,
wave soldering 1.6 mm (0.063 in.) from case for 10s
°C
260
0.6
Mounting torque, M3 screw
Maximum of mounting processes: 3
M
Nm
ThermalꢀResistance
Parameter
Symbol Conditions
Max.ꢀValue
Unit
Characteristic
IGBT thermal resistance,
junction - case
Rth(j-c)
Rth(j-c)
Rth(j-a)
0.35
0.35
40
K/W
K/W
K/W
Diode thermal resistance,
junction - case
Thermal resistance
junction - ambient
4
Rev.ꢀ2.1,ꢀꢀ2012-10-12
IHW40N120R3
InductionꢀHeatingꢀSeries
ElectricalꢀCharacteristic,ꢀatꢀTvjꢀ=ꢀ25°C,ꢀunlessꢀotherwiseꢀspecified
Value
Unit
min. typ. max.
Parameter
Symbol Conditions
StaticꢀCharacteristic
Collector-emitter breakdown voltage V(BR)CES VGEꢀ=ꢀ0V,ꢀICꢀ=ꢀ0.20mA
VGEꢀ=ꢀ15.0V,ꢀICꢀ=ꢀ40.0A
Tvjꢀ=ꢀ25°C
Collector-emitter saturation voltage VCEsat
Tvjꢀ=ꢀ125°C
1200
-
-
V
V
-
-
-
1.55 1.75
1.80
1.90
-
-
Tvjꢀ=ꢀ175°C
VGEꢀ=ꢀ0V,ꢀIFꢀ=ꢀ40.0A
Tvjꢀ=ꢀ25°C
Tvjꢀ=ꢀ125°C
Tvjꢀ=ꢀ175°C
-
-
-
1.60 1.80
Diode forward voltage
VF
V
V
1.70
1.80
-
-
Gate-emitter threshold voltage
VGE(th)
ICꢀ=ꢀ1.00mA,ꢀVCEꢀ=ꢀVGE
5.1
5.8
6.4
VCEꢀ=ꢀ1200V,ꢀVGEꢀ=ꢀ0V
Tvjꢀ=ꢀ25°C
Tvjꢀ=ꢀ175°C
Zero gate voltage collector current ICES
-
-
-
-
100.0 µA
2500.0
Gate-emitter leakage current
Transconductance
IGES
gfs
VCEꢀ=ꢀ0V,ꢀVGEꢀ=ꢀ20V
VCEꢀ=ꢀ20V,ꢀICꢀ=ꢀ40.0A
-
-
-
100
-
nA
S
35.3
none
Integrated gate resistor
rG
Ω
ElectricalꢀCharacteristic,ꢀatꢀTvjꢀ=ꢀ25°C,ꢀunlessꢀotherwiseꢀspecified
Value
Parameter
Symbol Conditions
Unit
min. typ. max.
DynamicꢀCharacteristic
Input capacitance
Cies
-
-
-
2708
87
-
-
-
Output capacitance
Coes
Cres
VCEꢀ=ꢀ25V,ꢀVGEꢀ=ꢀ0V,ꢀfꢀ=ꢀ1MHz
pF
Reverse transfer capacitance
76
VCCꢀ=ꢀ960V,ꢀICꢀ=ꢀ40.0A,ꢀ
VGEꢀ=ꢀ15V
Gate charge
QG
LE
-
-
335.0
13.0
-
-
nC
nH
Internal emitter inductance
measured 5mm (0.197 in.) from
case
SwitchingꢀCharacteristic,ꢀInductiveꢀLoad
Value
Parameter
Symbol Conditions
Unit
min. typ. max.
IGBTꢀCharacteristic,ꢀatꢀTvjꢀ=ꢀ25°C
Turn-off delay time
Fall time
td(off)
tf
-
-
-
336
38
-
-
-
ns
ns
Tvjꢀ=ꢀ25°C,
VCCꢀ=ꢀ600V,ꢀICꢀ=ꢀ40.0A,
VGEꢀ=ꢀ0.0/15.0V,
rGꢀ=ꢀ7.5Ω,ꢀLσꢀ=ꢀ220nH,
Cσꢀ=ꢀ40pF
Turn-off energy
Eoff
2.02
mJ
Lσ,ꢀCσꢀfromꢀFig.ꢀE
Energy losses include “tail” and
diode reverse recovery.
Turn-off energy, soft switching
Eoff
dv/dtꢀ=ꢀ150.0V/µs
-
0.48
-
mJ
5
Rev.ꢀ2.1,ꢀꢀ2012-10-12
IHW40N120R3
InductionꢀHeatingꢀSeries
SwitchingꢀCharacteristic,ꢀInductiveꢀLoad
Value
Unit
min. typ. max.
Parameter
Symbol Conditions
IGBTꢀCharacteristic,ꢀatꢀTvjꢀ=ꢀ175°C
Turn-off delay time
Fall time
td(off)
tf
-
-
-
410
96
-
-
-
ns
ns
Tvjꢀ=ꢀ175°C,
VCCꢀ=ꢀ600V,ꢀICꢀ=ꢀ40.0A,
VGEꢀ=ꢀ0.0/15.0V,
rGꢀ=ꢀ7.5Ω,ꢀLσꢀ=ꢀ220nH,
Cσꢀ=ꢀ40pF
Turn-off energy
Eoff
3.93
mJ
Lσ,ꢀCσꢀfromꢀFig.ꢀE
Energy losses include “tail” and
diode reverse recovery.
Turn-off energy, soft switching
Eoff
dv/dtꢀ=ꢀ150.0V/µs
-
0.78
-
mJ
6
Rev.ꢀ2.1,ꢀꢀ2012-10-12
IHW40N120R3
InductionꢀHeatingꢀSeries
450
400
350
300
250
200
150
100
50
100
10
1
tp=1µs
5µs
10µs
50µs
1ms
10ms
DC
0.1
0
1
10
100
1000
25
50
75
100
125
150
175
VCE,ꢀCOLLECTOR-EMITTERꢀVOLTAGEꢀ[V]
TC,ꢀCASEꢀTEMPERATUREꢀ[°C]
Figure 1. Forwardꢀbiasꢀsafeꢀoperatingꢀarea
(D=0,ꢀTC=25°C,ꢀTvj≤175°C;ꢀVGE=15V)
Figure 2. Powerꢀdissipationꢀasꢀaꢀfunctionꢀofꢀcase
temperature
(Tvj≤175°C)
80
70
60
50
40
30
20
10
0
120
110
VGE=20V
100
17V
90
15V
80
70
60
50
40
30
20
10
0
13V
11V
9V
7V
5V
25
50
75
100
125
150
175
0.0
0.5
1.0
1.5
2.0
2.5
3.0
3.5
4.0
TC,ꢀCASEꢀTEMPERATUREꢀ[°C]
VCE,ꢀCOLLECTOR-EMITTERꢀVOLTAGEꢀ[V]
Figure 3. Collectorꢀcurrentꢀasꢀaꢀfunctionꢀofꢀcase
temperature
Figure 4. Typicalꢀoutputꢀcharacteristic
(Tvj=25°C)
(VGE≥15V,ꢀTvj≤175°C)
7
Rev.ꢀ2.1,ꢀꢀ2012-10-12
IHW40N120R3
InductionꢀHeatingꢀSeries
120
110
100
90
80
70
60
50
40
30
20
10
0
120
Tj=25°C
Tj=175°C
110
100
90
80
70
60
50
40
30
20
10
0
VGE=20V
17V
15V
13V
11V
9V
7V
5V
0.0
0.5
1.0
1.5
2.0
2.5
3.0
3.5
4.0
4
5
6
7
8
9
10
11
12
VCE,ꢀCOLLECTOR-EMITTERꢀVOLTAGEꢀ[V]
VGE,ꢀGATE-EMITTERꢀVOLTAGEꢀ[V]
Figure 5. Typicalꢀoutputꢀcharacteristic
(Tvj=175°C)
Figure 6. Typicalꢀtransferꢀcharacteristic
(VCE=20V)
3.0
IC=20A
IC=40A
IC=80A
td(off)
tf
1000
100
10
2.5
2.0
1.5
1.0
0
25
50
75
100
125
150
175
0
10
20
30
40
50
60
Tvj,ꢀJUNCTIONꢀTEMPERATUREꢀ[°C]
IC,ꢀCOLLECTORꢀCURRENTꢀ[A]
Figure 7. Typicalꢀcollector-emitterꢀsaturationꢀvoltageꢀas Figure 8. Typicalꢀswitchingꢀtimesꢀasꢀaꢀfunctionꢀof
aꢀfunctionꢀofꢀjunctionꢀtemperature
collectorꢀcurrent
(VGE=15V)
(inductiveꢀload,ꢀTvj=175°C,ꢀVCE=600V,
VGE=15/0V,ꢀrG=7,5Ω,ꢀDynamicꢀtestꢀcircuitꢀin
Figure E)
8
Rev.ꢀ2.1,ꢀꢀ2012-10-12
IHW40N120R3
InductionꢀHeatingꢀSeries
1000
td(off)
tf
td(off)
tf
1000
100
10
100
10
0
10
20
30
40
50
25
50
75
100
125
150
175
rG,ꢀGATEꢀRESISTORꢀ[Ω]
Tvj,ꢀJUNCTIONꢀTEMPERATUREꢀ[°C]
Figure 9. Typicalꢀswitchingꢀtimesꢀasꢀaꢀfunctionꢀofꢀgate Figure 10. Typicalꢀswitchingꢀtimesꢀasꢀaꢀfunctionꢀof
resistor
junctionꢀtemperature
(inductiveꢀload,ꢀTvj=175°C,ꢀVCE=600V,
VGE=15/0V,ꢀIC=40A,Dynamicꢀtestꢀcircuitꢀin
Figure E)
(inductiveꢀload,ꢀVCE=600V,ꢀVGE=15/0V,
IC=40A,ꢀrG=7,5Ω,Dynamicꢀtestꢀcircuitꢀin
Figure E)
8
7
6
5
4
3
2
7
6
5
4
3
2
1
0
typ.
min.
max.
Eoff
0
25
50
75
100
125
150
175
0
10
20
30
40
50
60
70
80
Tvj,ꢀJUNCTIONꢀTEMPERATUREꢀ[°C]
IC,ꢀCOLLECTORꢀCURRENTꢀ[A]
Figure 11. Gate-emitterꢀthresholdꢀvoltageꢀasꢀaꢀfunction Figure 12. Typicalꢀswitchingꢀenergyꢀlossesꢀasꢀa
ofꢀjunctionꢀtemperature
(IC=1mA)
functionꢀofꢀcollectorꢀcurrent
(inductiveꢀload,ꢀTvj=175°C,ꢀVCE=600V,
VGE=15/0V,ꢀrG=7,5Ω,Dynamicꢀtestꢀcircuitꢀin
Figure E)
9
Rev.ꢀ2.1,ꢀꢀ2012-10-12
IHW40N120R3
InductionꢀHeatingꢀSeries
6
5
4
3
2
4.0
3.5
Eoff
Eoff
3.0
2.5
2.0
1.5
1.0
0
10
20
30
40
50
25
50
75
100
125
150
175
rG,ꢀGATEꢀRESISTORꢀ[Ω]
Tvj,ꢀJUNCTIONꢀTEMPERATUREꢀ[°C]
Figure 13. Typicalꢀswitchingꢀenergyꢀlossesꢀasꢀa
functionꢀofꢀgateꢀresistor
Figure 14. Typicalꢀswitchingꢀenergyꢀlossesꢀasꢀa
functionꢀofꢀjunctionꢀtemperature
(inductiveꢀload,ꢀVCE=600V,ꢀVGE=15/0V,
IC=40A,ꢀrG=7,5Ω,Dynamicꢀtestꢀcircuitꢀin
Figure E)
(inductiveꢀload,ꢀTvj=175°C,ꢀVCE=600V,
VGE=15/0V,ꢀIC=40A,ꢀDynamicꢀtestꢀcircuitꢀin
Figure E)
7
6
3.0
Tj=25°C
Tj=175°C
2.5
2.0
1.5
1.0
0.5
0.0
Eoff
5
4
3
2
1
0
400 500 600 700 800 900 1000 1100 1200
100
1000
VCE,ꢀCOLLECTOR-EMITTERꢀVOLTAGEꢀ[V]
dv/dt,ꢀVOLTAGEꢀSLOPEꢀ[V/µs]
Figure 15. Typicalꢀswitchingꢀenergyꢀlossesꢀasꢀa
functionꢀofꢀcollectorꢀemitterꢀvoltage
(inductiveꢀload,ꢀTvj=175°C,ꢀVGE=15/0V,
IC=40A,ꢀrG=7,5Ω,Dynamicꢀtestꢀcircuitꢀin
Figure E)
Figure 16. Typicalꢀturnꢀoffꢀswitchingꢀenergyꢀlossꢀfor
softꢀswitching
(inductiveꢀload,ꢀTvj=175°C,ꢀVGE=15/0V,
IC=40A,ꢀrG=7,5Ω,Dynamicꢀtestꢀcircuitꢀin
Figure E)
10
Rev.ꢀ2.1,ꢀꢀ2012-10-12
IHW40N120R3
InductionꢀHeatingꢀSeries
16
14
12
10
8
1E+4
240V
960V
Ciss
Coss
Crss
1000
100
10
6
4
2
0
0
50
100 150 200 250 300 350 400
0
5
10
15
20
25
30
QGE,ꢀGATEꢀCHARGEꢀ[nC]
VCE,ꢀCOLLECTOR-EMITTERꢀVOLTAGEꢀ[V]
Figure 17. Typicalꢀgateꢀcharge
(IC=40A)
Figure 18. Typicalꢀcapacitanceꢀasꢀaꢀfunctionꢀof
collector-emitterꢀvoltage
(VGE=0V,ꢀf=1MHz)
1
1
D=0.5
0.2
D=0.5
0.2
0.1
0.1
0.1
0.1
0.05
0.05
0.02
0.02
0.01
0.01
single pulse
single pulse
0.01
0.01
i:
1
2
3
4
5
i:
1
2
3
4
5
ri[K/W]: 0.060632 0.080405 0.18889
0.015093 2.0E-3
0.01389068 0.1188353 1.860864
ri[K/W]: 0.060632 0.080405 0.18889
0.015093 2.0E-3
0.01389068 0.1188353 1.860864
τi[s]:
2.9E-4
2.2E-3
τi[s]:
2.9E-4
2.2E-3
0.001
1E-6
0.001
1E-5
1E-4
0.001
0.01
0.1
1
1E-6
1E-5
1E-4
0.001
0.01
0.1
1
tp,ꢀPULSEꢀWIDTHꢀ[s]
tp,ꢀPULSEꢀWIDTHꢀ[s]
Figure 19. IGBTꢀtransientꢀthermalꢀresistance
(D=tp/T)
Figure 20. Diodeꢀtransientꢀthermalꢀimpedanceꢀasꢀa
functionꢀofꢀpulseꢀwidth
(D=tp/T)
11
Rev.ꢀ2.1,ꢀꢀ2012-10-12
IHW40N120R3
InductionꢀHeatingꢀSeries
80
70
60
50
40
30
20
10
0
3.0
Tj=25°C
Tj=175°C
IF=20A
IF=40A
IF=80A
2.5
2.0
1.5
1.0
0.5
0.0
0.5
1.0
1.5
2.0
2.5
3.0
0
25
50
75
100
125
150
175
VF,ꢀFORWARDꢀVOLTAGEꢀ[V]
Tvj,ꢀJUNCTIONꢀTEMPERATUREꢀ[°C]
Figure 21. Typicalꢀdiodeꢀforwardꢀcurrentꢀasꢀaꢀfunction Figure 22. Typicalꢀdiodeꢀforwardꢀvoltageꢀasꢀaꢀfunction
ofꢀforwardꢀvoltage ofꢀjunctionꢀtemperature
12
Rev.ꢀ2.1,ꢀꢀ2012-10-12
IHW40N120R3
InductionꢀHeatingꢀSeries
PG-TO247-3
13
Rev.ꢀ2.1,ꢀꢀ2012-10-12
IHW40N120R3
InductionꢀHeatingꢀSeries
a
b
a
b
t
14
Rev.ꢀ2.1,ꢀꢀ2012-10-12
IHW40N120R3
InductionꢀHeatingꢀSeries
RevisionꢀHistory
IHW40N120R3
Revision:ꢀ2012-10-12,ꢀRev.ꢀ2.1
Previous Revision
Revision Date
Subjects (major changes since last revision)
2.1 2012-10-12 Final data sheet
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81726ꢀMünchen,ꢀGermany
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Withꢀrespectꢀtoꢀanyꢀexamplesꢀorꢀhintsꢀgivenꢀherein,ꢀanyꢀtypicalꢀvaluesꢀstatedꢀhereinꢀand/orꢀanyꢀinformationꢀregardingꢀthe
applicationꢀofꢀtheꢀdevice,ꢀInfineonꢀTechnologiesꢀherebyꢀdisclaimsꢀanyꢀandꢀallꢀwarrantiesꢀandꢀliabilitiesꢀofꢀanyꢀkind,
includingꢀwithoutꢀlimitation,ꢀwarrantiesꢀofꢀnon-infringementꢀofꢀintellectualꢀpropertyꢀrightsꢀofꢀanyꢀthirdꢀparty.
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Warnings
Dueꢀtoꢀtechnicalꢀrequirements,ꢀcomponentsꢀmayꢀcontainꢀdangerousꢀsubstances.ꢀForꢀinformationꢀonꢀtheꢀtypesꢀin
question,ꢀpleaseꢀcontactꢀtheꢀnearestꢀInfineonꢀTechnologiesꢀOffice.
TheꢀInfineonꢀTechnologiesꢀcomponentꢀdescribedꢀinꢀthisꢀDataꢀSheetꢀmayꢀbeꢀusedꢀinꢀlife-supportꢀdevicesꢀorꢀsystems
and/orꢀautomotive,ꢀaviationꢀandꢀaerospaceꢀapplicationsꢀorꢀsystemsꢀonlyꢀwithꢀtheꢀexpressꢀwrittenꢀapprovalꢀofꢀInfineon
Technologies,ꢀifꢀaꢀfailureꢀofꢀsuchꢀcomponentsꢀcanꢀreasonablyꢀbeꢀexpectedꢀtoꢀcauseꢀtheꢀfailureꢀofꢀthatꢀlife-support,
automotive,ꢀaviationꢀandꢀaerospaceꢀdeviceꢀorꢀsystemꢀorꢀtoꢀaffectꢀtheꢀsafetyꢀorꢀeffectivenessꢀofꢀthatꢀdeviceꢀorꢀsystem.ꢀLife
supportꢀdevicesꢀorꢀsystemsꢀareꢀintendedꢀtoꢀbeꢀimplantedꢀinꢀtheꢀhumanꢀbodyꢀorꢀtoꢀsupportꢀand/orꢀmaintainꢀandꢀsustain
and/orꢀprotectꢀhumanꢀlife.ꢀIfꢀtheyꢀfail,ꢀitꢀisꢀreasonableꢀtoꢀassumeꢀthatꢀtheꢀhealthꢀofꢀtheꢀuserꢀorꢀotherꢀpersonsꢀmayꢀbe
endangered.
15
Rev.ꢀ2.1,ꢀꢀ2012-10-12
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