80-M012PNB008SC-K619C41 [VINCOTECH]
Easy paralleling;Low turn-off losses;Low collector emitter saturation voltage;Positive temperature coefficient;Short tail current;
| 型号： | 80-M012PNB008SC-K619C41 |
| 厂家： | 
VINCOTECH |
| 描述： | Easy paralleling;Low turn-off losses;Low collector emitter saturation voltage;Positive temperature coefficient;Short tail current |
| 文件： | 总20页 (文件大小：6632K) |
| 中文： | 中文翻译 | 下载： | 下载PDF数据表文档文件 |
80-M012PNB008SC-K619C41
datasheet
MiniSKiiP PIM 0
1200 V / 8 A
Topology features
MiniSKiiP® 0 16 mm housing
● Converter+Inverter
● Temperature sensor
Component features
● Easy paralleling
● Low turn-off losses
● Low collector emitter saturation voltage
● Positive temperature coefficient
● Short tail current
Housing features
● Base isolation: Al2O3
● Easy assembly in one mounting step
● Flexible PCB design w/o pin holes
● Rugged solderless spring contacts
Schematic
Extra features
● Equivalent: SKiiP 03NAC12T4V1
Target applications
● Industrial Drives
● Embedded Drives
Types
● 80-M012PNB008SC-K619C41
Copyright Vincotech
1
01 May. 2022 / Revision 3
80-M012PNB008SC-K619C41
datasheet
Maximum Ratings
Tj = 25 °C, unless otherwise specified
Parameter
Symbol
Conditions
Value
Unit
Inverter Switch
VCES
Collector-emitter voltage
1200
16
V
A
IC
Collector current (DC current)
Repetitive peak collector current
Total power dissipation
Tj = Tjmax
Ts = 80 °C
Ts = 80 °C
Tj = 150 °C
ICRM
tp limited by Tjmax
Tj = Tjmax
24
A
Ptot
65
W
V
VGES
Gate-emitter voltage
±20
10
tSC
Short circuit ratings
VGE = 15 V, VCC = 800 V
µs
°C
Tjmax
Maximum junction temperature
175
Inverter Diode
VRRM
Peak repetitive reverse voltage
1200
15
V
A
IF
Forward current (DC current)
Surge (non-repetitive) forward current
Surge current capability
Tj = Tjmax
Ts = 80 °C
Tj = 25 °C
Ts = 80 °C
IFSM
I2t
36
A
Single Half Sine Wave,
tp = 10 ms
0
A2s
W
°C
Ptot
Total power dissipation
Tj = Tjmax
53
Tjmax
Maximum junction temperature
175
Rectifier Diode
VRRM
Peak repetitive reverse voltage
1600
32
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
200
200
51
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
01 May. 2022 / Revision 3
80-M012PNB008SC-K619C41
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
Visol
Visol
DC Test Voltage*
tp = 2 s
6000
2500
V
V
Isolation voltage
AC Voltage
With std lid
tp = 1 min
Creepage distance
Clearance
For more informations see handling
instructions
6,3
mm
mm
With std lid
For more informations see handling
instructions
6,3
Comparative Tracking Index
*100 % tested in production
CTI
≥ 200
Copyright Vincotech
3
01 May. 2022 / Revision 3
80-M012PNB008SC-K619C41
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]
Inverter Switch
Static
VGE(th)
VCEsat
ICES
IGES
rg
Gate-emitter threshold voltage
Collector-emitter saturation voltage
Collector-emitter cut-off current
Gate-emitter leakage current
Internal gate resistance
Input capacitance
VCE = VGE
0,00015 25
5,3
5,8
6,3
V
25
150
1,58
1,93
2,32
2,07(1)
15
0
8
V
1200
0
25
25
1
µA
nA
Ω
20
120
None
490
30
Cies
Cres
Qg
pF
pF
nC
f = 1 Mhz
0
25
25
25
Reverse transfer capacitance
Gate charge
VCC = 960 V
15
8
53
Thermal
λpaste = 2,5 W/mK
(HPTP)
(2)
Rth(j-s)
Thermal resistance junction to sink
Dynamic
1,45
K/W
25
61,2
60,8
td(on)
Turn-on delay time
Rise time
ns
ns
150
25
29,2
tr
150
25
29,8
Rgon = 32 Ω
Rgoff = 32 Ω
170,8
240,2
59,77
119,61
0,458
0,747
0,407
0,735
td(off)
Turn-off delay time
Fall time
ns
150
25
±15
600
8
tf
ns
150
25
QrFWD=0,495 µC
QrFWD=1,31 µC
Eon
Eoff
Turn-on energy (per pulse)
Turn-off energy (per pulse)
mWs
mWs
150
25
150
Copyright Vincotech
4
01 May. 2022 / Revision 3
80-M012PNB008SC-K619C41
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]
Inverter Diode
Static
25
2,57
2,49
2,65(1)
2,68(1)
0,06
VF
IR
Forward voltage
8
V
150
25
Reverse leakage current
Vr = 1200 V
mA
150
0,3
0,7
Thermal
λpaste = 2,5 W/mK
(HPTP)
(2)
Rth(j-s)
Thermal resistance junction to sink
Dynamic
1,78
K/W
25
4,85
6,62
IRRM
Peak recovery current
Reverse recovery time
Recovered charge
A
150
25
257,71
477,1
0,495
1,31
trr
ns
150
25
di/dt=220 A/µs
di/dt=233 A/µs
Qr
±15
600
8
μC
150
25
0,192
0,557
63,63
46,58
Erec
Reverse recovered energy
Peak rate of fall of recovery current
mWs
A/µs
150
25
(dirf/dt)max
150
Copyright Vincotech
5
01 May. 2022 / Revision 3
80-M012PNB008SC-K619C41
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
Rectifier Diode
Static
25
1,05
1,21(1)
1,1(1)
VF
IR
Forward voltage
8
V
125
0,976
Reverse leakage current
Vr = 1600 V
25
50
µA
Thermal
λpaste = 2,5 W/mK
(HPTP)
(2)
Rth(j-s)
Thermal resistance junction to sink
1,37
K/W
Thermistor
Static
R
ΔR/R
Imax
d
Rated resistance
Deviation of R100
Maximum Current
Power dissipation constant
A-value
25
1
kΩ
%
R100 = 1670 Ω
100
-2
2
3
mA
25
0,76
mW/K
1/K
7,635x10-3
1,73x10-5
A
B-value
1/K2
B
Vincotech Thermistor Reference
E
(1)
Value at chip level
(2)
Only valid with pre-applied Vincotech thermal interface material.
Copyright Vincotech
6
01 May. 2022 / Revision 3
80-M012PNB008SC-K619C41
datasheet
Inverter Switch Characteristics
figure 1.
IGBT
figure 2.
IGBT
Typical output characteristics
Typical output characteristics
IC = f(VCE
)
IC = f(VCE)
20
20
VGE
:
7 V
8 V
9 V
10 V
11 V
12 V
13 V
14 V
15 V
16 V
17 V
15
10
5
15
10
5
0
0
0
0
1
2
3
4
5
6
1
2
3
4
5
6
V
CE(V)
VCE(V)
tp
=
=
tp
=
250
15
μs
V
250
150
μs
°C
25 °C
Tj:
VGE
Tj =
150 °C
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 a function of pulse width
IC = f(VGE
)
Zth(j-s) = f(tp)
1
8
10
0
6
4
2
0
10
-1
10
0,5
0,2
0,1
-2
10
0,05
0,02
0,01
0,005
0
-3
10
-5
-4
10
-3
10
-2
10
-1
10
0
10
1
10
2
0,0
2,5
5,0
7,5
10,0
12,5
10
10
tp(s)
V
GE(V)
tp
=
=
250
10
μs
V
D =
tp / T
1,454
25 °C
Tj:
VCE
150 °C
Rth(j-s) =
K/W
IGBT thermal model values
R (K/W)
τ (s)
8,07E-02
2,38E-01
7,61E-01
2,12E-01
1,63E-01
1,16E+00
1,30E-01
3,19E-02
5,31E-03
6,85E-04
Copyright Vincotech
7
01 May. 2022 / Revision 3
80-M012PNB008SC-K619C41
datasheet
Inverter Switch Characteristics
figure 5.
IGBT
Safe operating area
IC = f(VCE
)
100
10
1
100µs
1ms
10ms
0,1
0,01
100ms
DC
1
10
100
1000
10000
V
CE(V)
D =
single pulse
Ts =
80
15
°C
V
VGE
=
Tj =
Tjmax
Copyright Vincotech
8
01 May. 2022 / Revision 3
80-M012PNB008SC-K619C41
datasheet
Inverter 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
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
1,777
25 °C
Tj:
150 °C
Rth(j-s) =
K/W
FWD thermal model values
R (K/W)
τ (s)
1,03E-01
3,00E-01
7,08E-01
3,52E-01
3,15E-01
1,17E+00
9,78E-02
2,95E-02
4,46E-03
8,74E-04
Copyright Vincotech
9
01 May. 2022 / Revision 3
80-M012PNB008SC-K619C41
datasheet
Rectifier 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
70
60
50
40
30
20
10
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
0,0
0,5
1,0
1,5
2,0
2,5
3,0
10
10
10
10
VF(V)
tp(s)
tp
=
250
μs
D =
tp / T
1,371
25 °C
Tj:
125 °C
Rth(j-s) =
K/W
Rectifier thermal model values
R (K/W)
τ (s)
6,75E-02
1,34E-01
6,34E-01
3,25E-01
1,24E-01
8,71E-02
1,56E+00
2,41E-01
4,40E-02
9,85E-03
2,12E-03
3,56E-04
Copyright Vincotech
10
01 May. 2022 / Revision 3
80-M012PNB008SC-K619C41
datasheet
Thermistor Characteristics
figure 10.
Thermistor
Typical PTC characteristic as function of temperature
RT = f(T)
2200
2000
1800
1600
1400
1200
1000
20
40
60
80
100
120
140
T(°C)
Copyright Vincotech
11
01 May. 2022 / Revision 3
80-M012PNB008SC-K619C41
datasheet
Inverter Switching Characteristics
figure 11.
IGBT
figure 12.
IGBT
Typical switching energy losses as a function of collector current
Typical switching energy losses as a function of IGBT turn on gate resistor
E = f(IC)
E = f(Rg)
1,75
1,50
1,25
1,00
0,75
0,50
0,25
0,00
1,50
1,25
1,00
0,75
0,50
0,25
0,00
Eon
Eon
Eoff
Eon
Eon
Eoff
Eoff
Eoff
0,0
2,5
5,0
7,5
10,0
12,5
15,0
0
25
50
75
100
125
150
IC(A)
Rg(Ω)
With an inductive load at
With an inductive load at
25 °C
25 °C
Tj:
Tj:
VCE
VGE
=
=
=
=
VCE
VGE
IC
=
=
=
600
±15
32
V
V
Ω
Ω
150 °C
600
±15
8
V
V
A
150 °C
Rgon
Rgoff
32
figure 13.
FWD
figure 14.
FWD
Typical reverse recovered energy loss as a function of collector current
Typical reverse recovered energy loss as a function of IGBT turn on gate resistor
Erec = f(IC)
Erec = f(Rg)
0,8
0,7
0,6
0,5
0,4
0,3
0,2
0,1
0,0
0,6
0,5
0,4
0,3
0,2
0,1
0,0
Erec
Erec
Erec
Erec
0,0
2,5
5,0
7,5
10,0
12,5
15,0
0
25
50
75
100
125
150
IC(A)
Rg(Ω)
With an inductive load at
With an inductive load at
25 °C
25 °C
Tj:
Tj:
VCE
VGE
Rgon
=
=
=
VCE
VGE
IC
=
=
=
600
±15
32
V
V
Ω
150 °C
600
±15
8
V
V
A
150 °C
Copyright Vincotech
12
01 May. 2022 / Revision 3
80-M012PNB008SC-K619C41
datasheet
Inverter Switching Characteristics
figure 15.
IGBT
figure 16.
IGBT
Typical switching times as a function of collector current
Typical switching times as a function of IGBT turn on gate resistor
t = f(IC)
t = f(Rg)
0
10
0
10
td(off)
td(on)
tf
tr
-1
td(off)
tf
10
-1
10
td(on)
tr
-2
10
-2
10
-3
10
0,0
2,5
5,0
7,5
10,0
12,5
15,0
0
25
50
75
100
125
150
IC(A)
Rg(Ω)
With an inductive load at
With an inductive load at
Tj =
Tj =
150
600
±15
32
°C
V
150
600
±15
8
°C
V
VCE
=
=
=
=
VCE
=
=
=
VGE
Rgon
Rgoff
VGE
IC
V
V
Ω
Ω
A
32
figure 17.
FWD
figure 18.
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(IC)
trr = f(Rgon)
0,9
0,8
0,7
0,6
0,5
0,4
0,3
0,2
0,1
0,0
0,9
0,8
0,7
0,6
0,5
0,4
0,3
0,2
0,1
0,0
trr
trr
trr
trr
0,0
2,5
5,0
7,5
10,0
12,5
15,0
0
25
50
75
100
125
150
IC(A)
R
gon(Ω)
25 °C
150 °C
With an inductive load at
With an inductive load at
25 °C
Tj:
Tj:
VCE
VGE
Rgon
=
=
=
VCE
VGE
IC
=
=
=
600
±15
32
V
V
Ω
150 °C
600
±15
8
V
V
A
Copyright Vincotech
13
01 May. 2022 / Revision 3
80-M012PNB008SC-K619C41
datasheet
Inverter Switching Characteristics
figure 19.
FWD
figure 20.
FWD
Typical recovered charge as a function of collector current
Typical recovered charge as a function of IGBT turn on gate resistor
Qr = f(IC)
Qr = f(Rgon)
2,00
1,75
1,50
1,25
1,00
0,75
0,50
0,25
0,00
1,75
1,50
1,25
1,00
0,75
0,50
0,25
0,00
Qr
Qr
Qr
Qr
0,0
2,5
5,0
7,5
10,0
12,5
15,0
0
25
50
75
100
125
150
IC(A)
Rgon(Ω)
With an inductive load at
With an inductive load at
25 °C
25 °C
Tj:
Tj:
VCE
VGE
Rgon
=
=
=
VCE
VGE
IC
=
=
=
600
±15
32
V
V
Ω
150 °C
600
±15
8
V
V
A
150 °C
figure 21.
FWD
figure 22.
FWD
Typical peak reverse recovery current as a function of collector current
Typical peak reverse recovery current as a function of IGBT turn on gate resistor
IRM = f(IC)
IRM = f(Rgon)
7
6
5
4
3
2
1
0
15,0
12,5
10,0
7,5
IRM
IRM
5,0
IRM
IRM
2,5
0,0
0,0
2,5
5,0
7,5
10,0
12,5
15,0
0
25
50
75
100
125
150
IC(A)
Rgon(Ω)
With an inductive load at
With an inductive load at
25 °C
25 °C
Tj:
Tj:
VCE
VGE
Rgon
=
=
=
VCE
VGE
IC
=
=
=
600
±15
32
V
V
Ω
150 °C
600
±15
8
V
V
A
150 °C
Copyright Vincotech
14
01 May. 2022 / Revision 3
80-M012PNB008SC-K619C41
datasheet
Inverter Switching Characteristics
figure 23.
FWD
figure 24.
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 turn on gate resistor
diF/dt, dirr/dt = f(IC)
diF/dt, dirr/dt = f(Rgon)
300
2500
2000
1500
1000
500
diF/dt ‒ ‒ ‒ ‒ ‒
diF/dt ‒ ‒ ‒ ‒ ‒
dirr/dt ──────
dirr/dt ──────
250
200
150
100
50
0
0,0
0
2,5
5,0
7,5
10,0
12,5
15,0
IC(A)
0
25
50
75
100
125
150
R
gon(Ω)
With an inductive load at
With an inductive load at
25 °C
25 °C
Tj:
Tj:
VCE
VGE
Rgon
=
=
=
VCE
VGE
IC
=
=
=
600
±15
32
V
V
Ω
150 °C
600
±15
8
V
V
A
150 °C
figure 25.
IGBT
Reverse bias safe operating area
IC = f(VCE
)
17,5
IC MAX
15,0
12,5
10,0
7,5
5,0
2,5
0,0
0
250
500
750
1000
1250
1500
V
CE(V)
Tj =
At
150
°C
Ω
Rgon
Rgoff
=
=
32
32
Ω
Copyright Vincotech
15
01 May. 2022 / Revision 3
80-M012PNB008SC-K619C41
datasheet
Inverter Switching Definitions
figure 26.
IGBT
figure 27.
IGBT
Turn-off Switching Waveforms & definition of tdoff, tEoff (ttEoff = 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.
IGBT
figure 29.
IGBT
Turn-off Switching Waveforms & definition of tf
Turn-on Switching Waveforms & definition of tr
IC
IC
VCE
tr
VCE
tf
Copyright Vincotech
16
01 May. 2022 / Revision 3
80-M012PNB008SC-K619C41
datasheet
Inverter Switching Definitions
figure 30.
FWD
figure 31.
FWD
Turn-off Switching Waveforms & definition of trr
Turn-on Switching Waveforms & definition of tQr (tQr = integrating time for Qr)
Qr
IF
IF
fitted
VF
Copyright Vincotech
17
01 May. 2022 / Revision 3
80-M012PNB008SC-K619C41
datasheet
Ordering Code
Version
Ordering Code
With std lid (6.5mm height) + no thermal grease
With thin lid (2.8mm height) + no thermal grease
80-M012PNB008SC-K619C41-/0A/
80-M012PNB008SC-K619C41-/0B/
80-M012PNB008SC-K619C41-/1A/
80-M012PNB008SC-K619C41-/1B/
80-M012PNB008SC-K619C41-/4A/
80-M012PNB008SC-K619C41-/4B/
80-M012PNB008SC-K619C41-/5A/
80-M012PNB008SC-K619C41-/5B/
With std lid (6.5mm height) + thermal grease (0,8 W/mK, P12, silicone-based)
With thin lid (2.8mm height) + thermal grease (0,8 W/mK, P12, silicone-based)
With std lid (6.5mm height) + thermal grease (2,5 W/mK, TG20032, silicone-free)
With thin lid (2.8mm height) + thermal grease (2,5 W/mK, TG20032, silicone-free)
With std lid (6.5mm height) + thermal grease (2,5 W/mK, HPTP, silicone-based)
With thin lid (2.8mm height) + thermal grease (2,5 W/mK, HPTP, silicone-based)
Marking
Name
Type&Ver
TTTTTTTVV
Serial
Date code
WWYY
VIN & Lot
Serial&UL
Text
NN-NNNNNNNNNNNNNN
VIN LLLLL
SSSS UL
Type&Ver
Lot number
Date code
WWYY
Datamatrix
TTTTTTTVV
LLLLL
SSSS
Outline
Pin table [mm]
Pin
1
X
Y
Function
G5
11,93
11,93
11,93
11,93
11,93
4,33
-11,5
-6,9
4,71
8,3
2
W
3
G6
4
+T
5
11,5
-11,5
-5,8
6,95
10,15
-11,5
-5,8
5,5
-T
6
G3
7
4,33
V
8
4,33
G4
9
4,33
-DC
G1
10
11
12
13
14
15
16
17
18
-3,27
-3,27
-3,27
-3,27
-11,07
-11,07
-11,07
-11,07
-11,07
U
-RECT
G2
11,5
-11,5
-8,3
-1,68
4,93
11,5
+DC
+RECT
L3
L2
L1
Pad positions refers to center point. For more informations on pad design please see package data
Copyright Vincotech
18
01 May. 2022 / Revision 3
80-M012PNB008SC-K619C41
datasheet
Pinout
+RECT
15
+DC
14
T1
T3
T5
D1
G3
D3
G5
D5
G1
D7
D9
D11
10
6
1
L1
L2
L3
U
18
17
16
11
7
V
W
2
D8
D10
D12
T2
T4
T6
D2
G4
D4
D6
G2
G6
13
8
3
PTC
+T
4
-T
5
-RECT
12
-DC
9
Identification
Component
Voltage
Current
Function
Comment
ID
T2, T1, T4, T3, T6, T5
IGBT
1200 V
8 A
Inverter Switch
D1, D2, D3, D4, D5,
FWD
1200 V
1600 V
8 A
Inverter Diode
D6
D8, D7, D10, D9, D12,
Rectifier
25 A
Rectifier Diode
Thermistor
D11
Rt
Thermistor
Copyright Vincotech
19
01 May. 2022 / Revision 3
80-M012PNB008SC-K619C41
datasheet
Packaging instruction
Handling instruction
Standard packaging quantity (SPQ) 198
>SPQ
Standard
<SPQ
Sample
Handling instructions for MiniSKiiP® 0 packages see vincotech.com website.
Package data
Package data for MiniSKiiP® 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
New Datasheet format, module is unchanged
Introduce Rth values with HPTP
80-M012PNB008SC-K619C41-D3-14
1 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
01 May. 2022 / Revision 3
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