10-PZ12B2A075ME-P621L18Y [VINCOTECH]
High Blocking Voltage with low drain source on state resistance;High speed SiC-MOSFET technology;Resistant to Latch-up;型号: | 10-PZ12B2A075ME-P621L18Y |
厂家: | VINCOTECH |
描述: | High Blocking Voltage with low drain source on state resistance;High speed SiC-MOSFET technology;Resistant to Latch-up |
文件: | 总20页 (文件大小:6856K) |
中文: | 中文翻译 | 下载: | 下载PDF数据表文档文件 |
10-PZ12B2A075ME-P621L18Y
datasheet
flowBOOST 0 dual SiC
1200 V / 75 mΩ
Topology features
flow 0 12 mm housing
● Kelvin Emitter for improved switching performance
● Dual Booster
● Bypass Diode
● Open Emitter configuration
● Temperature sensor
Component features
● High Blocking Voltage with low drain source on state resistance
● High speed SiC-MOSFET technology
● Resistant to Latch-up
Housing features
● Base isolation: Al2O3
● Clip-in, reliable mechanical connection, qualified for wave
soldering
Schematic
● Convex shaped substrate for superior thermal contact
● Thermo-mechanical push-and-pull force relief
● Press-fit pin
● Reliable cold welding connection
Target applications
● Solar Inverters
Types
● 10-PZ12B2A075ME-P621L18Y
Copyright Vincotech
1
05 May. 2022 / Revision 2
10-PZ12B2A075ME-P621L18Y
datasheet
Maximum Ratings
Tj = 25 °C, unless otherwise specified
Parameter
Symbol
Conditions
Value
Unit
Boost Switch
VDSS
Drain-source voltage
1200
20
V
A
ID
Drain current (DC current)
Peak drain current
Tj = Tjmax
Ts = 80 °C
Ts = 80 °C
IDM
tp limited by Tjmax
Tj = Tjmax
80
A
Ptot
Total power dissipation
52
W
-4 / 15
-8 / 19
175
VGSS
Gate-source voltage
V
dynamic
Tjmax
Maximum Junction Temperature
°C
Boost Diode
VRRM
Peak repetitive reverse voltage
1200
19
V
A
IF
Forward current (DC current)
Repetitive peak forward current
Surge (non-repetitive) forward current
Total power dissipation
Tj = Tjmax
Ts = 80 °C
IFRM
IFSM
Ptot
tp limited by Tjmax
52
A
Single Half Sine Wave,
tp = 10 ms
Tj = 25 °C
Ts = 80 °C
92
A
Tj = Tjmax
58
W
°C
Tjmax
Maximum junction temperature
175
ByPass Diode
VRRM
Peak repetitive reverse voltage
1600
38
V
A
IF
Forward current (DC current)
Surge (non-repetitive) forward current
Surge current capability
Tj = Tjmax
Ts = 80 °C
Tj = 150 °C
Ts = 80 °C
IFSM
I2t
270
370
47
A
Single Half Sine Wave,
tp = 10 ms
A2s
W
°C
Ptot
Total power dissipation
Tj = Tjmax
Tjmax
Maximum junction temperature
150
Copyright Vincotech
2
05 May. 2022 / Revision 2
10-PZ12B2A075ME-P621L18Y
datasheet
Maximum Ratings
Tj = 25 °C, unless otherwise specified
Parameter
Symbol
Conditions
Value
Unit
Module Properties
Thermal Properties
Tstg
Tjop
Storage temperature
-40…+125
°C
°C
Operation temperature under switching
condition
-40…+(Tjmax - 25)
Isolation Properties
Isolation voltage
Isolation voltage
Creepage distance
Clearance
Visol
Visol
DC Test Voltage*
tp = 2 s
6000
2500
V
AC Voltage
tp = 1 min
V
min 12,7
9,15
mm
mm
Comparative Tracking Index
*100 % tested in production
CTI
≥ 200
Copyright Vincotech
3
05 May. 2022 / Revision 2
10-PZ12B2A075ME-P621L18Y
datasheet
Characteristic Values
Symbol
Parameter
Conditions
Values
Typ
Unit
VCE [V] IC [A]
VDS [V] ID [A] Tj [°C]
VF [V] IF [A]
VGE [V]
VGS [V]
Min
Max
Boost Switch
Static
25
76,2
105
116
90(1)
rDS(on)
Drain-source on-state resistance
15
20
125
150
mΩ
VGS(th)
IGSS
IDSS
rg
Gate-source threshold voltage
Gate to Source Leakage Current
Zero Gate Voltage Drain Current
Internal gate resistance
Gate charge
0
0,005
25
25
25
1,7
2,5
10
4
V
15
0
0
250
100
nA
µA
Ω
1200
1
10,5
54
Qg
-4/15
800
20
0
25
25
25
nC
Ciss
Coss
Crss
VSD
Short-circuit input capacitance
Short-circuit output capacitance
Reverse transfer capacitance
Diode forward voltage
1350
58
f = 1 Mhz
0
0
1000
pF
V
3
10
4,5
Thermal
λpaste = 3,4 W/mK
(PSX)
(2)
Rth(j-s)
Thermal resistance junction to sink
Dynamic
1,84
K/W
25
14,4
12,8
td(on)
Turn-on delay time
Rise time
125
150
25
ns
ns
12,48
9,28
tr
125
150
25
9,28
8,96
Rgon = 8 Ω
Rgoff = 8 Ω
69,76
78,4
td(off)
Turn-off delay time
Fall time
125
150
25
ns
80,96
27,91
30,9
0/15
700
16
tf
125
150
25
ns
32,13
0,235
0,216
0,212
0,08
QrFWD=0,119 µC
QrFWD=0,113 µC
QrFWD=0,111 µC
Eon
Turn-on energy (per pulse)
Turn-off energy (per pulse)
125
150
25
mWs
mWs
Eoff
125
150
0,087
0,091
Copyright Vincotech
4
05 May. 2022 / Revision 2
10-PZ12B2A075ME-P621L18Y
datasheet
Characteristic Values
Symbol
Parameter
Conditions
Values
Typ
Unit
VCE [V] IC [A]
VDS [V] ID [A] Tj [°C]
VGE [V]
VGS [V]
Min
Max
VF [V]
IF [A]
Boost Diode
Static
25
1,43
1,73
1,84
1,8(1)
300
VF
IR
Forward voltage
10
125
150
V
Reverse leakage current
Thermal
Vr = 1200 V
25
40
µA
λpaste = 3,4 W/mK
(PSX)
(2)
Rth(j-s)
Thermal resistance junction to sink
Dynamic
1,64
K/W
25
7,75
8,71
IRRM
Peak recovery current
125
150
25
A
8,88
26,16
24,28
23,87
0,119
0,113
0,111
0,047
0,044
0,043
733,99
1159
trr
Reverse recovery time
125
150
25
ns
di/dt=2071 A/µs
di/dt=2263 A/µs
di/dt=2290 A/µs
Qr
Recovered charge
0/15
700
16
125
150
25
μC
Erec
Reverse recovered energy
Peak rate of fall of recovery current
125
150
25
mWs
A/µs
(dirf/dt)max
125
150
1267
Copyright Vincotech
5
05 May. 2022 / Revision 2
10-PZ12B2A075ME-P621L18Y
datasheet
Characteristic Values
Symbol
Parameter
Conditions
Values
Typ
Unit
VCE [V] IC [A]
VDS [V] ID [A] Tj [°C]
VF [V] IF [A]
VGE [V]
VGS [V]
Min
Max
ByPass Diode
Static
25
1,15
1,1
1,5(1)
VF
IR
Forward voltage
28
V
125
25
100
Reverse leakage current
Vr = 1600 V
µA
150
1000
Thermal
λpaste = 3,4 W/mK
(PSX)
(2)
Rth(j-s)
Thermal resistance junction to sink
1,5
K/W
Thermistor
Static
R
ΔR/R
P
Rated resistance
Deviation of R100
Power dissipation
Power dissipation constant
B-value
25
22
kΩ
%
R100 = 1484 Ω
100
25
-5
5
130
1,5
mW
mW/K
K
d
25
B(25/50)
Tol. ±1 %
Tol. ±1 %
3962
4000
B(25/100)
B-value
K
Vincotech Thermistor Reference
I
(1)
Value at chip level
(2)
Only valid with pre-applied Vincotech thermal interface material.
Copyright Vincotech
6
05 May. 2022 / Revision 2
10-PZ12B2A075ME-P621L18Y
datasheet
Boost Switch Characteristics
figure 1.
MOSFET
figure 2.
MOSFET
Typical output characteristics
Typical output characteristics
ID = f(VDS
)
ID = f(VDS)
80
80
VGS
:
-4 V
-2 V
0 V
60
40
2 V
60
40
20
0
4 V
6 V
8 V
20
10 V
12 V
14 V
16 V
18 V
20 V
0
-20
-40
-60
-80
0,0
2,5
5,0
7,5
10,0
12,5
-12,5 -10,0 -7,5 -5,0 -2,5 0,0
2,5
5,0
7,5 10,0 12,5
V
DS(V)
VDS(V)
tp
=
=
tp
=
250
16
μs
V
250
150
μs
°C
25 °C
VGS
Tj =
125 °C
150 °C
Tj:
VGS from -4 V to 20 V in steps of 2 V
figure 3.
MOSFET
figure 4.
MOSFET
Typical transfer characteristics
Transient thermal impedance as a function of pulse width
ID = f(VGS
)
Zth(j-s) = f(tp)
1
35
10
30
25
20
15
10
5
0
10
-1
10
0,5
0,2
-2
10
0,1
0,05
0,02
0,01
0,005
0
-3
0
0
10
-5
-4
10
-3
10
-2
10
-1
10
0
10
1
10
2
10
2
4
6
8
10
10
V
GS(V)
tp(s)
tp
=
=
250
10
μs
V
D =
tp / T
1,843
25 °C
VDS
125 °C
150 °C
Rth(j-s) =
Tj:
K/W
MOSFET thermal model values
R (K/W)
τ (s)
1,10E-01
4,15E-01
7,53E-01
4,02E-01
1,64E-01
1,89E+00
1,55E-01
3,96E-02
6,20E-03
7,03E-04
Copyright Vincotech
7
05 May. 2022 / Revision 2
10-PZ12B2A075ME-P621L18Y
datasheet
Boost Switch Characteristics
figure 5.
MOSFET
Safe operating area
ID = f(VDS
)
100
10
1
0,1
0,01
1
10
100
1000
10000
V
DS(V)
D =
single pulse
Ts =
80
16
°C
V
VGS
=
Tj =
Tjmax
Copyright Vincotech
8
05 May. 2022 / Revision 2
10-PZ12B2A075ME-P621L18Y
datasheet
Boost Diode Characteristics
figure 6.
FWD
figure 7.
FWD
Typical forward characteristics
Transient thermal impedance as a function of pulse width
IF = f(VF)
Zth(j-s) = f(tp)
1
30
25
20
15
10
5
10
0
10
-1
10
0,5
0,2
0,1
-2
10
0,05
0,02
0,01
0,005
0
-3
0
10
-5
-4
10
-3
10
-2
10
-1
10
0
1
2
0
1
2
3
4
5
10
10
10
10
tp(s)
VF(V)
tp
=
250
μs
D =
tp / T
1,635
25 °C
125 °C
150 °C
Rth(j-s) =
Tj:
K/W
FWD thermal model values
R (K/W)
τ (s)
1,05E-01
2,66E-01
7,28E-01
4,30E-01
1,07E-01
2,56E+00
2,22E-01
4,00E-02
5,14E-03
8,14E-04
Copyright Vincotech
9
05 May. 2022 / Revision 2
10-PZ12B2A075ME-P621L18Y
datasheet
ByPass Diode Characteristics
figure 8.
Rectifier
figure 9.
Rectifier
Typical forward characteristics
Transient thermal impedance as a function of pulse width
IF = f(VF)
Zth(j-s) = f(tp)
1
80
60
40
20
0
10
0
10
-1
10
0,5
0,2
-2
10
0,1
0,05
0,02
0,01
0,005
0
-3
10
-5
-4
10
-3
10
-2
10
-1
10
0
1
2
0,00
0,25
0,50
μs
0,75
1,00
1,25
1,50
1,75
2,00
VF(V)
10
10
10
10
tp(s)
tp
=
250
D =
tp / T
1,5
25 °C
Tj:
125 °C
Rth(j-s) =
K/W
Rectifier thermal model values
R (K/W)
τ (s)
9,44E-02
3,47E-01
7,44E-01
2,04E-01
1,11E-01
2,48E+00
3,51E-01
7,63E-02
1,21E-02
1,25E-03
Copyright Vincotech
10
05 May. 2022 / Revision 2
10-PZ12B2A075ME-P621L18Y
datasheet
Thermistor Characteristics
figure 10.
Thermistor
Typical NTC characteristic as function of temperature
RT = f(T)
25000
20000
15000
10000
5000
0
20
40
60
80
100
120
140
T(°C)
Copyright Vincotech
11
05 May. 2022 / Revision 2
10-PZ12B2A075ME-P621L18Y
datasheet
Boost Switching Characteristics
figure 11.
MOSFET
figure 12.
MOSFET
Typical switching energy losses as a function of drain current
Typical switching energy losses as a function of MOSFET turn on gate resistor
E = f(ID)
E = f(Rg)
0,5
0,4
0,3
0,2
0,1
0,0
0,5
0,4
0,3
0,2
0,1
0,0
Eon
Eon
Eon
Eon
Eon
Eon
Eoff
Eoff
Eoff
Eoff
Eoff
Eoff
0
5
10
15
20
25
30
35
0
5
10
15
20
25
30
35
ID(A)
Rg(Ω)
With an inductive load at
With an inductive load at
25 °C
25 °C
VDS
VGS
=
=
=
=
VDS
VGS
ID
=
=
=
700
0/15
8
V
125 °C
150 °C
700
0/15
16
V
125 °C
150 °C
Tj:
Tj:
V
V
A
Rgon
Rgoff
Ω
Ω
8
figure 13.
FWD
figure 14.
FWD
Typical reverse recovered energy loss as a function of drain current
Typical reverse recovered energy loss as a function of MOSFET turn on gate resistor
Erec = f(ID)
Erec = f(Rg)
0,06
0,05
0,04
0,03
0,02
0,01
0,00
0,05
0,04
0,03
0,02
0,01
0,00
Erec
Erec
Erec
Erec
Erec
Erec
0
5
10
15
20
25
30
35
0
5
10
15
20
25
30
35
ID(A)
Rg(Ω)
With an inductive load at
With an inductive load at
25 °C
25 °C
VDS
VGS
=
=
=
VDS
VGS
ID
=
=
=
700
0/15
8
V
V
125 °C
150 °C
700
0/15
16
V
V
A
125 °C
150 °C
Tj:
Tj:
Rgon
Ω
Copyright Vincotech
12
05 May. 2022 / Revision 2
10-PZ12B2A075ME-P621L18Y
datasheet
Boost Switching Characteristics
figure 15.
MOSFET
figure 16.
MOSFET
Typical switching times as a function of drain current
Typical switching times as a function of MOSFET turn on gate resistor
t = f(ID)
t = f(Rg)
0
10
0
10
td(off)
-1
10
-1
10
td(off)
td(on)
tr
tf
tf
td(on)
-2
tr
-2
10
10
10
10
-3
-3
0
5
10
15
20
25
30
35
0
5
10
15
20
25
30
35
ID(A)
Rg(Ω)
With an inductive load at
With an inductive load at
Tj =
Tj =
150
700
0/15
8
°C
150
700
0/15
16
°C
VDS
=
=
=
=
VDS
=
=
=
V
V
Ω
Ω
V
V
A
VGS
Rgon
Rgoff
VGS
ID
8
figure 17.
FWD
figure 18.
FWD
Typical reverse recovery time as a function of drain current
Typical reverse recovery time as a function of MOSFET turn on gate resistor
trr = f(ID)
trr = f(Rgon)
0,035
0,030
0,025
0,020
0,015
0,010
0,005
0,000
0,07
0,06
0,05
0,04
0,03
0,02
0,01
0,00
trr
trr
trr
trr
trr
trr
0
5
10
15
20
25
30
35
0
5
10
15
20
25
30
35
ID(A)
Rgon(Ω)
VDS
=
=
=
VDS
VGS
ID
=
=
=
At
700
0/15
8
V
V
Ω
At
700
0/15
16
V
V
A
25 °C
25 °C
VGS
125 °C
150 °C
125 °C
150 °C
Tj:
Tj:
Rgon
Copyright Vincotech
13
05 May. 2022 / Revision 2
10-PZ12B2A075ME-P621L18Y
datasheet
Boost Switching Characteristics
figure 19.
FWD
figure 20.
FWD
Typical recovered charge as a function of drain current
Typical recovered charge as a function of MOSFET turn on gate resistor
Qr = f(ID)
Qr = f(Rgon)
0,150
0,125
0,100
0,075
0,050
0,025
0,000
0,175
0,150
0,125
0,100
0,075
0,050
0,025
0,000
Qr
Qr
Qr
Qr
Qr
Qr
0
5
10
15
20
25
30
35
0
5
10
15
20
25
30
35
ID(A)
Rgon(Ω)
VDS
=
=
=
VDS
=
=
=
At
700
0/15
8
V
V
Ω
At
700
0/15
16
V
V
A
25 °C
25 °C
VGS
VGS
ID
125 °C
150 °C
125 °C
150 °C
Tj:
Tj:
Rgon
figure 21.
FWD
figure 22.
FWD
Typical peak reverse recovery current as a function of drain current
Typical peak reverse recovery current as a function of MOSFET turn on gate resistor
IRM = f(ID)
IRM = f(Rgon)
10
17,5
15,0
12,5
10,0
7,5
IRM
IRM
8
IRM
6
4
IRM
IRM
IRM
5,0
2
2,5
0
0,0
0
5
10
15
20
25
30
35
0
5
10
15
20
25
30
35
ID(A)
Rgon(Ω)
VDS
VGS
=
=
=
VDS
VGS
ID
=
=
=
At
700
0/15
8
V
At
700
0/15
16
V
V
A
25 °C
25 °C
V
125 °C
150 °C
125 °C
150 °C
Tj:
Tj:
Rgon
Ω
Copyright Vincotech
14
05 May. 2022 / Revision 2
10-PZ12B2A075ME-P621L18Y
datasheet
Boost Switching Characteristics
figure 23.
FWD
figure 24.
FWD
Typical rate of fall of forward and reverse recovery current as a function of drain current
Typical rate of fall of forward and reverse recovery current as a function of turn on gate resistor
diF/dt, dirr/dt = f(ID)
diF/dt, dirr/dt = f(Rgon)
3500
6000
5000
4000
3000
2000
1000
0
diF/dt ‒ ‒ ‒ ‒ ‒
dirr/dt ──────
diF/dt ‒ ‒ ‒ ‒ ‒
dirr/dt ──────
3000
2500
2000
1500
1000
500
0
0
5
10
15
20
25
30
35
0
5
10
15
20
25
30
35
ID(A)
Rgon(Ω)
VDS
=
=
=
VDS
=
=
=
At
700
0/15
8
V
V
Ω
At
700
0/15
16
V
V
A
25 °C
25 °C
VGS
VGS
ID
125 °C
150 °C
125 °C
150 °C
Tj:
Tj:
Rgon
figure 25.
MOSFET
Reverse bias safe operating area
ID = f(VDS
)
45
ID MAX
40
35
30
25
20
15
10
5
0
0
250
500
750
1000
1250
1500
V
DS(V)
Tj =
At
150
°C
Rgon
Rgoff
=
=
8
8
Ω
Ω
Copyright Vincotech
15
05 May. 2022 / Revision 2
10-PZ12B2A075ME-P621L18Y
datasheet
Boost Switching Definitions
figure 26.
MOSFET
figure 27.
MOSFET
Turn-off Switching Waveforms & definition of tdoff, tEoff (tEoff = integrating time for Eoff
)
Turn-on Switching Waveforms & definition of tdon, tEon (tEon = integrating time for Eon
)
tdoff
IC
IC
VGE
VGE
VCE
tEoff
VCE
tEon
figure 28.
MOSFET
figure 29.
MOSFET
Turn-off Switching Waveforms & definition of tf
Turn-on Switching Waveforms & definition of tr
ID
IC
VCE
tr
VDS
tf
Copyright Vincotech
16
05 May. 2022 / Revision 2
10-PZ12B2A075ME-P621L18Y
datasheet
Boost Switching Definitions
figure 30.
FWD
figure 31.
FWD
Turn-off Switching Waveforms & definition of ttrr
Turn-on Switching Waveforms & definition of tQrr (tQrr = integrating time for Qrr)
Qr
IF
IF
fitted
VF
figure 32.
FWD
Turn-on Switching Waveforms & definition of tErec (tErec = integrating time for Erec
)
%
Erec
tErec
Prec
3.01
3.1
3.19
3.28
3.37
3.46
t (µs)
Copyright Vincotech
17
05 May. 2022 / Revision 2
10-PZ12B2A075ME-P621L18Y
datasheet
Ordering Code
Version
Ordering Code
Without thermal paste
10-PZ12B2A075ME-P621L18Y
10-PZ12B2A075ME-P621L18Y-/7/
10-PZ12B2A075ME-P621L18Y-/3/
With thermal paste (5,2 W/mK, PTM6000HV)
With thermal paste (3,4 W/mK, PSX-P7)
Marking
Name
Date code
UL & VIN
Lot
Serial
Text
NN-NNNNNNNNNNNNNN-
TTTTTTVV
WWYY
UL VIN
LLLLL
SSSS
Type&Ver
Lot number
Serial
Date code
Datamatrix
TTTTTTTVV
LLLLL
SSSS
WWYY
Outline
Pin table [mm]
Pin
1
X
Y
Function
G25
0
22,5
22,5
22,5
2
2,9
8,3
S25
3
DC-
Boost1
DC-
4
10,8
22,5
Boost1
DC+Boost
DC+Boost
DC+In1
DC+In1
Boost1
Boost1
Boost2
Boost2
DC+In2
DC+In2
DC+Boost
DC+Boost
DC-
5
19,6
22,1
29,1
32
22,5
22,5
22,5
22,5
17,8
15,3
7,2
4,7
0
6
7
8
9
33,5
33,5
33,5
33,5
32
10
11
12
13
14
15
16
17
29,1
22,1
19,6
10,8
0
0
0
0
Boost2
DC-
18
8,3
0
Boost2
S27
19
20
21
22
2,9
0
0
0
G27
0
8
Therm1
Therm2
0
14,5
Copyright Vincotech
18
05 May. 2022 / Revision 2
10-PZ12B2A075ME-P621L18Y
datasheet
Pinout
DC+Boost
5,6,15,16
DC+In1
7,8
DC+In2
13,14
D26
D28
D25
D27
Boost1
9,10
Boost2
11,12
T25
T27
G25
1
G27
20
S25
2
S27
19
Rt
3,4
DC-Boost1
17,18
DC-Boost2
21
Therm1
22
Therm2
Identification
Component
Voltage
Current
Function
Comment
ID
T25, T27
D25, D27
D26, D28
Rt
MOSFET
FWD
1200 V
1200 V
1600 V
75 mΩ
10 A
Boost Switch
Boost Diode
ByPass Diode
Thermistor
Rectifier
Thermistor
28 A
Copyright Vincotech
19
05 May. 2022 / Revision 2
10-PZ12B2A075ME-P621L18Y
datasheet
Packaging instruction
Handling instruction
Standard packaging quantity (SPQ) 135
>SPQ
Standard
<SPQ
Sample
Handling instructions for flow 0 packages see vincotech.com website.
Package data
Package data for flow 0 packages see vincotech.com website.
Vincotech thermistor reference
See Vincotech thermistor reference table at vincotech.com website.
UL recognition and file number
This device is certified according to UL 1557 standard, UL file number E192116. For more information see vincotech.com website.
Document No.:
Date:
Modification:
Pages
-/7/ ordering option added
New Datasheet format, module is unchanged
10-PZ12B2A075ME-P621L18Y-D2-14
5 May. 2022
DISCLAIMER
The information, specifications, procedures, methods and recommendations herein (together “information”) are presented by Vincotech to
reader in good faith, are believed to be accurate and reliable, but may well be incomplete and/or not applicable to all conditions or situations
that may exist or occur. Vincotech reserves the right to make any changes without further notice to any products to improve reliability,
function or design. No representation, guarantee or warranty is made to reader as to the accuracy, reliability or completeness of said
information or that the application or use of any of the same will avoid hazards, accidents, losses, damages or injury of any kind to persons
or property or that the same will not infringe third parties rights or give desired results. It is reader’s sole responsibility to test and determine
the suitability of the information and the product for reader’s intended use.
LIFE SUPPORT POLICY
Vincotech products are not authorised for use as critical components in life support devices or systems without the express written approval
of Vincotech.
As used herein:
1. Life support devices or systems are devices or systems which, (a) are intended for surgical implant into the body, or (b) support or
sustain life, or (c) whose failure to perform when properly used in accordance with instructions for use provided in labelling can be
reasonably expected to result in significant injury to the user.
2. A critical component is any component of a life support device or system whose failure to perform can be reasonably expected to cause
the failure of the life support device or system, or to affect its safety or effectiveness.
Copyright Vincotech
20
05 May. 2022 / Revision 2
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