10-PY126TA050SH-L828F68Y [VINCOTECH]

Easy paralleling;High speed switching;Low switching losses;
10-PY126TA050SH-L828F68Y
型号: 10-PY126TA050SH-L828F68Y
厂家: VINCOTECH    VINCOTECH
描述:

Easy paralleling;High speed switching;Low switching losses

文件: 总16页 (文件大小:2979K)
中文:  中文翻译
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10-PY126TA050SH-L828F68Y  
datasheet  
flowPACK 1  
1200 V / 50 A  
Features  
flow 1 12mm housing  
● High speed IGBT4  
● Tandem diodes for improved thermal performance  
● Integrated thermal sensor  
Schematic  
Target applications  
● Embedded Drives  
● Industrial Drives  
Types  
● 10-PY126TA050SH-L828F68Y  
Maximum Ratings  
Tj = 25 °C, unless otherwise specified  
Parameter  
Symbol  
Condition  
Value  
Unit  
Inverter Switch  
VCES  
IC  
Collector-emitter voltage  
1200  
48  
V
A
Collector current  
Tj = Tjmax  
Ts = 80 °C  
Ts = 80 °C  
Tj = 150 °C  
ICRM  
Ptot  
VGES  
tSC  
Repetitive peak collector current  
Total power dissipation  
Gate-emitter voltage  
tp limited by Tjmax  
Tj = Tjmax  
150  
122  
±20  
10  
A
W
V
Short circuit ratings  
VGE = 15 V  
Vcc = 800 V  
µs  
°C  
Tjmax  
Maximum junction temperature  
175  
Copyright Vincotech  
1
13 Dec. 2018 / Revision 2  
10-PY126TA050SH-L828F68Y  
datasheet  
Maximum Ratings  
Tj = 25 °C, unless otherwise specified  
Parameter  
Symbol  
Condition  
Value  
Unit  
Inverter Diode  
VRRM  
IF  
IFRM  
Ptot  
Peak repetitive reverse voltage  
1300  
38  
V
A
Continuous (direct) forward current  
Repetitive peak forward current  
Total power dissipation  
Tj = Tjmax  
Ts = 80 °C  
Ts = 80 °C  
100  
102  
175  
A
Tj = Tjmax  
W
°C  
Tjmax  
Maximum junction temperature  
Module Properties  
Thermal Properties  
Tstg  
Tjop  
Storage temperature  
-40…+125  
°C  
°C  
Operation temperature under switching condition  
Isolation Properties  
-40…(Tjmax - 25)  
DC Test Voltage*  
AC Voltage  
tp = 2 s  
6000  
2500  
V
Visol  
Isolation voltage  
tp = 1 min  
V
Creepage distance  
min. 12,7  
7,9  
mm  
mm  
Clearance  
Comparative Tracking Index  
*100 % tested in production  
CTI  
> 200  
Copyright Vincotech  
2
13 Dec. 2018 / Revision 2  
10-PY126TA050SH-L828F68Y  
datasheet  
Characteristic Values  
Parameter  
Symbol  
Conditions  
Value  
Typ  
Unit  
VCE [V] IC [A]  
VGE [V]  
VGS [V]  
VDS [V] ID [A] Tj [°C]  
VF [V] IF [A]  
Min  
Max  
Inverter Switch  
Static  
VGE(th)  
Gate-emitter threshold voltage  
VGE = VCE  
0,0017 25  
25  
5,3  
5,8  
6,3  
V
V
1,78  
2,04  
2,38  
2,46  
2,42  
VCEsat  
Collector-emitter saturation voltage  
15  
50  
125  
150  
ICES  
IGES  
rg  
Collector-emitter cut-off current  
Gate-emitter leakage current  
Internal gate resistance  
Input capacitance  
0
1200  
0
25  
25  
1
µA  
nA  
Ω
20  
120  
4
Cies  
Cres  
2770  
160  
f = 1 Mhz  
0
25  
25  
pF  
Reverse transfer capacitance  
Thermal  
λpaste = 3,4 W/mK  
(PSX)  
Rth(j-s)  
Thermal resistance junction to sink  
0,78  
K/W  
Dynamic  
25  
92  
95  
96  
td(on)  
125  
150  
25  
Turn-on delay time  
20  
tr  
Rise time  
125  
150  
25  
125  
150  
25  
125  
150  
25  
125  
150  
25  
24  
25  
185  
236  
252  
55  
Rgon = 8 Ω  
Rgoff = 8 Ω  
ns  
td(off)  
Turn-off delay time  
Fall time  
±15  
600  
50  
tf  
87  
90  
2,052  
2,898  
3,130  
2,008  
3,178  
Qr  
FWD  
Qr  
FWD  
Qr  
FWD  
= 1,6 μC  
= 3 μC  
= 3,5 μC  
Eon  
Turn-on energy (per pulse)  
mWs  
125  
Eoff  
Turn-off energy (per pulse)  
150  
3,525  
Copyright Vincotech  
3
13 Dec. 2018 / Revision 2  
10-PY126TA050SH-L828F68Y  
datasheet  
Characteristic Values  
Parameter  
Symbol  
Conditions  
Value  
Typ  
Unit  
VCE [V] IC [A]  
VGE [V]  
VGS [V]  
VDS [V] ID [A] Tj [°C]  
VF [V] IF [A]  
Min  
Max  
Inverter Diode  
Static  
25  
3,23  
3,09  
3,03  
3,54  
2,65  
VF  
IR  
125  
150  
Forward voltage  
50  
V
Reverse leakage current  
1300  
25  
µA  
Thermal  
λpaste = 3,4 W/mK  
(PSX)  
Rth(j-s)  
Thermal resistance junction to sink  
0,93  
K/W  
Dynamic  
25  
32  
40  
43  
IRRM  
125  
150  
25  
Peak recovery current  
A
109  
trr  
Qr  
Reverse recovery time  
125  
150  
25  
125  
150  
25  
125  
150  
25  
125  
150  
149  
167  
ns  
di/dt = 2600 A/μs  
di/dt = 2009 A/μs  
di/dt = 3015 A/μs  
1,606  
3,039  
3,547  
0,516  
0,987  
1,172  
1844  
156  
±15  
600  
50  
Recovered charge  
μC  
Erec  
Reverse recovered energy  
Peak rate of fall of recovery current  
mWs  
A/µs  
(dirf/dt)max  
171  
Thermistor  
R
ΔR/R  
P
Rated resistance  
25  
100  
25  
25  
25  
25  
22  
kΩ  
%
Deviation of R100  
Power dissipation  
Power dissipation constant  
B-value  
R100 = 1484 Ω  
-5  
5
5
mW  
mW/K  
K
1,5  
B(25/50)  
Tol. ±1 %  
Tol. ±1 %  
3962  
4000  
B(25/100)  
B-value  
K
Vincotech NTC Reference  
I
Copyright Vincotech  
4
13 Dec. 2018 / Revision 2  
10-PY126TA050SH-L828F68Y  
datasheet  
Inverter Switch Characteristics  
figure 1.  
IGBT  
figure 2.  
IGBT  
Typical output characteristics  
Typical output characteristics  
I C = f(VCE  
)
I C = f(VCE)  
150  
150  
VGE  
:
7
V
V
V
I
I
8
9
120  
10  
11  
12  
13  
14  
15  
16  
17  
V
V
V
V
V
V
V
V
120  
90  
60  
30  
0
90  
60  
30  
0
0
0
1
2
3
4
5
1
2
3
4
5
VC E (V)  
VC E (V)  
tp  
=
250  
15  
μs  
25 °C  
125 °C  
150 °C  
tp  
Tj  
=
=
250  
150  
μs  
°C  
VGE  
=
V
Tj:  
VGE from  
7 V to 17 V in steps of 1 V  
figure 3.  
IGBT  
figure 4.  
IGBT  
Typical transfer characteristics  
Transient thermal impedance as function of pulse duration  
I C = f(VGE  
)
Z th(j-s) = f(tp)  
100  
50  
I
40  
Z
10-1  
30  
20  
10  
0,5  
10-2  
0,2  
0,1  
0,05  
0,02  
0,01  
0,005  
0
10-3  
10-5  
0
0
10-4  
10-3  
10-2  
10-1  
100  
101  
tp(s)  
102  
2
4
6
8
10  
12  
VG E (V)  
tp  
=
100  
10  
μs  
25 °C  
125 °C  
150 °C  
D =  
R th(j-s)  
tp / T  
VCE  
=
V
Tj:  
=
0,78  
K/W  
IGBT thermal model values  
R (K/W)  
τ (s)  
1,24E-01  
3,94E-01  
1,70E-01  
6,32E-02  
3,04E-02  
9,17E-01  
1,41E-01  
4,90E-02  
9,18E-03  
9,28E-04  
Copyright Vincotech  
5
13 Dec. 2018 / Revision 2  
10-PY126TA050SH-L828F68Y  
datasheet  
Inverter Switch Characteristics  
figure 5.  
IGBT  
Safe operating area  
I C = f(VCE  
)
1000  
I
10ms  
1ms  
100µs  
10µs  
100ms  
DC  
100  
10  
1
0,1  
0,01  
1
10  
100  
1000  
10000  
VC E (V)  
single pulse  
80 ºC  
D =  
Ts  
=
VGE  
=
±15  
V
Tj =  
Tjmax  
Copyright Vincotech  
6
13 Dec. 2018 / Revision 2  
10-PY126TA050SH-L828F68Y  
datasheet  
Inverter Diode Characteristics  
figure 1.  
FWD  
figure 2.  
FWD  
Typical forward characteristics  
Transient thermal impedance as a function of pulse width  
I F = f(VF)  
Z th(j-s) = f(tp)  
100  
150  
120  
90  
60  
30  
0
Z
10-1  
0,5  
0,2  
0,1  
0,05  
0,02  
0,01  
0,005  
0
10-2  
10-4  
10-3  
10-2  
10-1  
100  
101  
102  
tp (s)  
0
1
2
3
4
5
VF (V)  
tp  
=
250  
μs  
25 °C  
125 °C  
150 °C  
D =  
tp / T  
0,93  
Tj:  
R th(j-s)  
=
K/W  
FWD thermal model values  
R (K/W)  
τ (s)  
5,47E-02  
1,44E-01  
4,22E-01  
2,08E-01  
7,41E-02  
3,12E-02  
3,65E+00  
5,33E-01  
1,06E-01  
2,50E-02  
4,04E-03  
4,73E-04  
Thermistor Characteristics  
figure 1.  
Thermistor  
Typical Thermistor resistance values  
Typical NTC characteristic as a function of temperature  
as a function of temperature  
R = f(T)  
NTC-typical temperature characteristic  
25000  
20000  
15000  
10000  
5000  
0
25  
50  
75  
100  
125  
T (°C)  
Copyright Vincotech  
7
13 Dec. 2018 / Revision 2  
10-PY126TA050SH-L828F68Y  
datasheet  
Inverter Switching Characteristics  
figure 1.  
IGBT  
figure 2.  
IGBT  
Typical switching energy losses as a function of collector current  
Typical switching energy losses as a function of gate resistor  
E = f(R g)  
E = f(I C  
)
8
8
E
E
Eon  
Eon  
Eon  
Eoff  
Eon  
6
6
Eoff  
Eon  
Eon  
4
2
0
4
2
0
Eoff  
Eoff  
Eoff  
Eoff  
0
20  
40  
60  
80  
100  
IC (A)  
0
5
10  
15  
20  
25  
30  
35  
Rg (Ω)  
With an inductive load at  
25 °C  
With an inductive load at  
25 °C  
VCE  
VGE  
=
=
=
=
600  
±15  
8
V
V
Ω
Ω
Tj:  
VCE  
VGE  
I C  
=
=
=
600  
±15  
50  
V
V
A
Tj:  
125 °C  
150 °C  
125 °C  
150 °C  
R gon  
R goff  
8
figure 3.  
FWD  
figure 4.  
FWD  
Typical reverse recovered energy loss as a function of collector current  
Typical reverse recovered energy loss as a function of gate resistor  
Erec = f(I c)  
Erec = f(R g)  
2
2
E
E
Erec  
1,6  
1,6  
Erec  
1,2  
0,8  
0,4  
0
1,2  
0,8  
0,4  
0
Erec  
Erec  
Erec  
Erec  
0
5
10  
15  
20  
25  
30  
35  
0
20  
40  
60  
80  
100  
IC (A)  
Rg (Ω)  
With an inductive load at  
25 °C  
With an inductive load at  
25 °C  
VCE  
VGE  
=
=
=
600  
±15  
8
V
V
Ω
Tj:  
VCE  
VGE  
I C  
=
=
=
600  
±15  
50  
V
V
A
Tj:  
125 °C  
150 °C  
125 °C  
150 °C  
R gon  
Copyright Vincotech  
8
13 Dec. 2018 / Revision 2  
10-PY126TA050SH-L828F68Y  
datasheet  
Inverter Switching Characteristics  
figure 5.  
IGBT  
figure 6.  
IGBT  
Typical switching times as a function of collector current  
Typical switching times as a function of gate resistor  
t = f(I C  
)
t = f(R g)  
1
1
td(off)  
t
t
td(off)  
td(on)  
tf  
td(on)  
0,1  
0,1  
tf  
tr  
tr  
0,01  
0,01  
0,001  
0,001  
0
5
10  
15  
20  
25  
30  
35  
0
20  
40  
60  
80  
100  
IC (A)  
Rg (Ω)  
With an inductive load at  
With an inductive load at  
Tj =  
150  
600  
±15  
8
°C  
V
Tj =  
150  
600  
±15  
50  
°C  
V
VCE  
=
=
=
=
VCE  
=
=
=
VGE  
R gon  
R goff  
V
VGE  
I C  
V
Ω
Ω
A
8
figure 7.  
FWD  
figure 8.  
FWD  
Typical reverse recovery time as a function of collector current  
Typical reverse recovery time as a function of IGBT turn on gate resistor  
trr = f(I C  
)
trr = f(R gon)  
0,25  
0,3  
t
t
trr  
trr  
trr  
trr  
0,25  
0,2  
0,2  
0,15  
0,1  
0,15  
0,1  
0,05  
0
trr  
trr  
0,05  
0
0
0
20  
40  
60  
80  
100  
5
10  
15  
20  
25  
30  
35  
Rgon (Ω)  
IC (A)  
With an inductive load at  
25 °C  
With an inductive load at  
25 °C  
VCE  
=
=
=
600  
±15  
8
V
V
Ω
Tj:  
VCE  
VGE  
I C  
=
=
=
600  
±15  
50  
V
V
A
Tj:  
125 °C  
150 °C  
125 °C  
150 °C  
VGE  
R gon  
Copyright Vincotech  
9
13 Dec. 2018 / Revision 2  
10-PY126TA050SH-L828F68Y  
datasheet  
Inverter Switching Characteristics  
figure 9.  
FWD  
figure 10.  
FWD  
Typical recovered charge as a function of collector current  
Typical recovered charge as a function of IGBT turn on gate resistor  
Q r = f(I C  
)
Q r = f(R gon)  
6
4
Q
Q
Qr  
Qr  
Qr  
Qr  
4,5  
3
3
1,5  
0
2
1
Qr  
Qr  
0
0
0
10  
20  
30  
40  
50  
60  
70  
80  
90  
IC (A)  
100  
5
10  
15  
20  
25  
30  
35  
Rg on (Ω)  
With an inductive load at  
25 °C  
With an inductive load at  
25 °C  
VCE  
=
=
=
600  
±15  
8
V
V
Ω
Tj:  
VCE=  
VGE =  
I C=  
600  
±15  
50  
V
V
A
Tj:  
125 °C  
150 °C  
125 °C  
150 °C  
VGE  
R gon  
figure 11.  
FWD  
figure 12.  
FWD  
Typical peak reverse recovery current current as a function of collector current  
Typical peak reverse recovery current as a function of IGBT turn on gate resistor  
I RM = f(I C  
)
I RM = f(R gon)  
60  
100  
IRM  
IRM  
IRM  
I
I
50  
80  
40  
30  
20  
10  
60  
40  
20  
IRM  
IRM  
IRM  
0
0
0
0
5
10  
15  
20  
25  
30  
35  
Rgo n (Ω)  
20  
40  
60  
80  
100  
IC (A)  
With an inductive load at  
25 °C  
With an inductive load at  
25 °C  
VCE  
=
=
=
600  
±15  
8
V
V
Ω
Tj:  
VCE  
VGE  
I C  
=
=
=
600  
±15  
50  
V
V
A
Tj:  
125 °C  
150 °C  
125 °C  
150 °C  
VGE  
R gon  
Copyright Vincotech  
10  
13 Dec. 2018 / Revision 2  
10-PY126TA050SH-L828F68Y  
datasheet  
Inverter Switching Characteristics  
figure 13.  
FWD  
figure 14.  
FWD  
Typical rate of fall of forward and reverse recovery current as a function of collector current  
Typical rate of fall of forward and reverse recovery current as a function of IGBT turn on gate resistor  
di F/dt, di rr/dt = f(I C  
)
di F/dt, di rr/dt = f(R gon)  
10000  
4000  
diF/dt  
dir r/dt  
diF/dt  
t
dirr/dt  
t
i
i
8000  
3000  
6000  
4000  
2000  
0
2000  
1000  
0
0
0
5
10  
15  
20  
25  
30  
35  
Rgon (Ω)  
20  
40  
60  
80  
100  
IC (A)  
With an inductive load at  
25 °C  
With an inductive load at  
25 °C  
VCE  
=
=
=
600  
±15  
8
V
V
Ω
Tj:  
VCE =  
VGE =  
I C=  
600  
±15  
50  
V
Tj:  
125 °C  
150 °C  
125 °C  
150 °C  
VGE  
V
A
R gon  
figure 15.  
IGBT  
Reverse bias safe operating area  
I C = f(VCE  
)
120  
I
IC MAX  
100  
I
80  
60  
40  
20  
0
I
V
0
200  
400  
600  
800  
1000  
1200  
1400  
VC E (V)  
At  
Tj =  
125  
°C  
Ω
R gon  
R goff  
=
=
8
8
Ω
Copyright Vincotech  
11  
13 Dec. 2018 / Revision 2  
10-PY126TA050SH-L828F68Y  
datasheet  
Inverter Switching Definitions  
General conditions  
T j  
=
=
=
125 °C  
Rgon  
Rgoff  
8 Ω  
8 Ω  
figure 1.  
IGBT  
figure 2.  
IGBT  
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  
%
%
VGE 90%  
VCE 90%  
IC  
IC  
VGE  
VGE  
VCE  
tdon  
tEoff  
IC 1%  
VCE 3%  
VCE  
IC 10%  
VGE 10%  
tEon  
t (µs)  
t (µs)  
VGE (0%) =  
-15  
15  
V
VGE (0%) =  
-15  
V
VGE (100%) =  
VC (100%) =  
I C (100%) =  
V
VGE (100%) =  
VC (100%) =  
I C (100%) =  
15  
V
600  
50  
V
600  
50  
V
A
A
tdoff  
=
236  
ns  
tdon  
=
95  
ns  
figure 3.  
IGBT  
figure 4.  
IGBT  
Turn-off Switching Waveforms & definition of tf  
Turn-on Switching Waveforms & definition of tr  
fitted  
%
%
IC  
IC  
IC 90%  
IC 60%  
IC 40%  
VCE  
IC 90%  
tr  
IC10%  
VCE  
IC 10%  
tf  
t (µs)  
t (µs)  
VC (100%) =  
I C (100%) =  
tf =  
600  
50  
V
VC (100%) =  
I C (100%) =  
600  
50  
V
A
A
87  
ns  
tr  
=
24  
ns  
Copyright Vincotech  
12  
13 Dec. 2018 / Revision 2  
10-PY126TA050SH-L828F68Y  
datasheet  
Inverter Switching Characteristics  
figure 5.  
FWD  
figure 6.  
FWD  
Turn-off Switching Waveforms & definition of trr  
Turn-on Switching Waveforms & definition of tQr (tQr = integrating time for Qr)  
%
%
Qr  
trr  
tQr  
IF  
IF  
fitted  
IRRM 10%  
VF  
IRRM 90%  
IRRM 100%  
t (µs)  
t (µs)  
VF (100%) =  
I F (100%) =  
I RRM (100%) =  
600  
50  
V
I F (100%) =  
Q r (100%) =  
50  
A
A
3,04  
μC  
40  
A
trr  
=
149  
ns  
Copyright Vincotech  
13  
13 Dec. 2018 / Revision 2  
10-PY126TA050SH-L828F68Y  
datasheet  
Ordering Code & Marking  
Version  
without thermal paste 12mm housing with Press-fit pins  
with thermal paste 12mm housing with Press-fit pins  
Ordering Code  
10-PY126TA050SH-L828F68Y  
10-PY126TA050SH-L828F68Y-/3/  
Name  
Date code  
WWYY  
UL & VIN  
UL VIN  
Lot  
Serial  
NN-NNNNNNNNNNNNNN  
TTTTTTVV WWYY UL  
VIN LLLLL SSSS  
Text  
NN-NNNNNNNNNNNNNN-TTTTTTVV  
LLLLL  
SSSS  
Type&Ver  
Lot number  
Serial  
Date code  
WWYY  
Datamatrix  
TTTTTTTVV  
LLLLL  
SSSS  
Outline  
Pin table  
Pin  
X
Y
0
0
0
0
0
0
0
0
0
0
Functions  
DC-123  
52,6  
49,9  
42,65  
39,65  
35,15  
28,4  
24  
1
2
DC-123  
G15  
3
4
S15  
5
Therm1  
Therm2  
G13  
6
7
8
21  
S13  
9
12,2  
9,2  
G11  
10  
S11  
11  
12  
13  
2,7  
0
0
0
0
DC-123  
DC-123  
DC+123  
14,65  
14  
15  
16  
17  
18  
19  
20  
21  
22  
2,7  
0
14,65  
28,6  
28,6  
28,6  
28,6  
28,6  
28,6  
28,6  
28,6  
DC+123  
Ph1  
2,7  
5,4  
9,6  
12,6  
19,6  
22,3  
25  
Ph1  
Ph1  
S12  
G12  
Ph2  
Ph2  
Ph2  
23  
24  
25  
26  
27  
28  
29  
30  
31  
29,7  
32,7  
39,7  
42,7  
47,2  
49,9  
52,6  
52,6  
49,9  
28,6  
28,6  
28,6  
28,6  
28,6  
28,6  
28,6  
14,65  
14,65  
S14  
G14  
S16  
G16  
Ph3  
Ph3  
Ph3  
DC+123  
DC+123  
Copyright Vincotech  
14  
13 Dec. 2018 / Revision 2  
10-PY126TA050SH-L828F68Y  
datasheet  
Pinout  
Identification  
ID  
Component  
Voltage  
Current  
Function  
Comment  
T11, T12, T13, T14,  
T15, T16  
IGBT  
1200 V  
50 A  
50 A  
Inverter Switch  
D11, D12, D13, D14,  
D15, D16  
FWD  
NTC  
1300 V  
Inverter Diode  
Thermistor  
Rt  
Copyright Vincotech  
15  
13 Dec. 2018 / Revision 2  
10-PY126TA050SH-L828F68Y  
datasheet  
Packaging instruction  
Handling instruction  
Standard packaging quantity (SPQ) 100  
>SPQ  
Standard  
<SPQ  
Sample  
Handling instructions for flow 1 packages see vincotech.com website.  
Package data  
Package data for flow 1 packages see 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  
10-PY126TA050SH-L828F68Y-D2-14  
13 Dec. 2018  
Correct IC, Ptot, Rth(j-s) of Inverter Switch  
1, 3, 5  
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  
16  
13 Dec. 2018 / Revision 2  

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