V23990-K203-B-PM

datasheet

MiniSKiiP® 1 PIM 600 V / 15 A

®
Features MiniSKiiP 1 housing

● Solderless interconnection
● Trench Fieldstop IGBT3 technology

Target Applications Schematic

● Industrial drives

Types

● V23990-K203-B-PM

Maximum Ratings
T j = 25 °C, unless otherwise specified

Parameter Symbol Condition Value Unit

Rectifier Diode
Repetitive peak reverse voltage V RRM 1600 V

DC forward current I FAV T j = T jmax T s = 80 °C 29 A

Surge (non-repetitive) forward current I FSM 220 A

t p = 10 ms
2 2 half sine wave
I t-value I t 240 A2s

Power dissipation P tot T j = T jmax T s = 80 °C 46 W

Maximum Junction Temperature T jmax 150 °C

Inverter Switch / Brake Switch

Collector-emitter breakdown voltage V CE 600 V

DC collector current IC T j = T jmax T s = 80 °C 20 A

Repetitive peak collector current I CRM t p limited by T jmax 45 A

Power dissipation P tot T j = T jmax T s = 80 °C 53 W

Gate-emitter peak voltage V GE ±20 V

t SC T j ≤ 150 °C 6 µs
Short circuit ratings
V CC V GE = 15 V 360 V

Maximum Junction Temperature T jmax 175 °C

copyright Vincotech 1 03 Aug. 2016 / Revision 2

 V23990-K203-B-PM
datasheet

Maximum Ratings
T j = 25 °C, unless otherwise specified

Parameter Symbol Condition Value Unit

Inverter Diode / Brake Diode

Repetitive peak reverse voltage V RRM 600 V

DC forward current IF T j = T jmax T s = 80 °C 20 A

Repetitive peak forward current I FRM t p limited by T jmax 40 A

Power dissipation P tot T j = T jmax T s = 80 °C 38 W

Maximum Junction Temperature T jmax 175 °C

Thermal Properties
Storage temperature T stg -40…+125 °C

Operation temperature under switching condition T op -40…+(T jmax - 25) °C

Isolation Properties
Isolation voltage V is t = 2s DC Test Voltage 4000 V

Creepage distance min 12,7 mm

Clearance min 12,7 mm

Comparative Tracking Index CTI >200

copyright Vincotech 2 03 Aug. 2016 / Revision 2

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datasheet
Characteristic Values
Parameter Symbol Conditions Value Unit
V r [V] I C [A]
V GE [V]
V CE [V] I F [A] T j [°C] Min Typ Max
V GS [V]
V DS [V] I D [A]

Rectifier Diode
25 1,51
Forward voltage VF 25 V
125 1,42
25 0,86
Threshold voltage (for power loss calc. only) V to 25 V
125 0,79
25 0,03
Slope resistance (for power loss calc. only) rt 25 Ω
125 0,03
Reverse current Ir 1500 25 0,05 mA

Thermal grease
Thermal resistance junction to sink R th(j-s) thickness ≤ 50um 1,50 K/W
λ = 1 W/mK

Inverter Switch / Brake Switch

Gate emitter threshold voltage V GE(th) V CE = V GE 0,00021 25 5 5,8 6,5 V

25 1,1 1,73 1,9

Collector-emitter saturation voltage V CEsat 15 15 V
150 1,87
Collector-emitter cut-off current incl. Diode I CES 0 600 25 0,0085 mA

Gate-emitter leakage current I GES 20 0 25 300 nA

Integrated Gate resistor R gint none Ω

25 25
Turn-on delay time t d(on)
150 23
25 25
Rise time tr
150 30
ns
25 183
Turn-off delay time t d(off)
R goff = 8 Ω 150 202
0/15 300 15
R gon = 16 Ω 25 104
Fall time tf
150 109
25 0,46
Turn-on energy loss E on
150 0,58
mWs
25 0,36
Turn-off energy loss E off
150 0,46
Input capacitance C ies 860

Output capacitance C oss f = 1 MHz 0 25 25 55 pF

Reverse transfer capacitance C rss 24

Gate charge QG 0/15 480 15 25 87 nC

Thermal grease
Thermal resistance junction to sink R th(j-s) thickness ≤ 50um 1,81 K/W
λ = 1 W/mK

Inverter Diode / Brake Diode

25 1,44 1,6
Diode forward voltage VF 15 V
125 1,42
25 8,5
Peak reverse recovery current I RRM A
125 10,3
25 189
Reverse recovery time t rr ns
125 275
25 0,64
Reverse recovered charge Q rr di F/d t = tbd A/us 0/15 300 15 µC
125 1,12
25 90
Peak rate of fall of recovery current ( di rf/dt )max A/µs
125 55
25 0,12
Reverse recovered energy E rec mWs
125 0,22
Thermal grease
Thermal resistance junction to sink R th(j-s) thickness ≤ 50um 2,51 K/W
λ = 1 W/mK

Thermistor
Rated resistance R 25 1000 Ω

Deviation of R 100 Δ R/R R 100 = 1670 Ω 100 -3 3 %

R 100 R 100 1670,3125 Ω

Power dissipation constant 25 mW/K

A-value B (25/50) 25 7,635*10-3 1/K

-5
B-value B (25/100) 25 1,731*10 1/K²

Vincotech NTC Reference E

copyright Vincotech 3 03 Aug. 2016 / Revision 2

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Inverter Switch / Brake Switch / Inverter Diode / Brake Diode

figure 1. IGBT figure 2. IGBT

Typical output characteristics Typical output characteristics
I C = f(V CE) I C = f(V CE)
50 50

IC (A)
IC (A)

40 40

30 30

20 20

10 10

0 0
0 1 2 3 4 V CE (V) 5 0 1 2 3 4 V CE (V) 5

At At
tp = 250 µs tp = 250 µs
Tj = 25 °C Tj = 125 °C
V GE from 7 V to 17 V in steps of 1 V V GE from 7 V to 17 V in steps of 1 V

figure 3. IGBT figure 4. FWD

Typical transfer characteristics Typical diode forward current as
I C = f(V GE) a function of forward voltage
I F = f(V F)
16 50
IF (A)
IC (A)

T c=80°C 40
12 Tj = 25 °C

30
Tj = Tjmax-25 °C
8

20

4
Tj = Tjmax-25 °C 10

Tj = 25 °C
0 0
0 2 4 6 8 V GE (V) 10 0 0,5 1 1,5 2 2,5 V F (V) 3

At At
tp = 250 µs tp = 250 µs
V CE = 10 V

copyright Vincotech 4 03 Aug. 2016 / Revision 2

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Inverter Switch / Brake Switch / Inverter Diode / Brake Diode

figure 5. IGBT figure 6. IGBT

Typical switching energy losses Typical switching energy losses
as a function of collector current as a function of gate resistor
E = f(I C) E = f(R G)
1,6 1,2
Eon High T Eon High T

E (mWs)
E (mWs)

Eon Low T 1 Eon Low T

1,2

0,8

0,8 0,6
Eoff High T Eoff High T
Eoff Low T
Eoff Low T
0,4

0,4

0,2

0 0
0 5 10 15 20 25 I C (A) 30 0 25 50 75 100 125 R G ( Ω ) 150

With an inductive load at With an inductive load at

Tj = 25/125 °C Tj = 25/125 °C
V CE = 300 V V CE = 300 V
V GE = 15 V V GE = 15 V
R gon = 32 Ω IC = 15 A
R goff = 16 Ω

figure 7. FWD figure 8. FWD

Typical reverse recovery energy loss Typical reverse recovery energy loss
as a function of collector current as a function of gate resistor
E rec = f(I C) E rec = f(R G)
0,4 0,4
Erec
E (mWs)

E (mWs)

Tj = Tjmax
-25 °C

0,3 0,3

Tj = Tjmax
Erec -25 °C
Erec
0,2 0,2
Tj = 25 °C

Tj = 25 °C
Erec
0,1 0,1

0 0
0 5 10 15 20 25 I C (A) 30 0 25 50 75 100 125 R G ( Ω ) 150

With an inductive load at With an inductive load at

Tj = 25/125 °C Tj = 25/125 °C
V CE = 300 V V CE = 300 V
V GE = 15 V V GE = 15 V
R gon = 32 Ω IC = 15 A

copyright Vincotech 5 03 Aug. 2016 / Revision 2

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Inverter Switch / Brake Switch / Inverter Diode / Brake Diode

figure 9. IGBT figure 10. IGBT

Typical switching times as a Typical switching times as a
function of collector current function of gate resistor
t = f(I C) t = f(R G)
1 1
t ( µs)

tdoff

t ( µs)
tdoff
tf
0,1 0,1
tf tdon
tr
tdon

0,01 tr 0,01

0,001 0,001
0 5 10 15 20 25 I C (A) 30 0 25 50 75 100 125 R G ( Ω ) 150

With an inductive load at With an inductive load at

Tj = 125 °C Tj = 125 °C
V CE = 300 V V CE = 300 V
V GE = 15 V V GE = 15 V
R gon = 32 Ω IC = 15 A
R goff = 16 Ω

figure 11. FWD figure 12. FWD

Typical reverse recovery time as a Typical reverse recovery time as a
function of collector current function of IGBT turn on gate resistor
t rr = f(I C) t rr = f(R gon)
0,6 0,5
t rr( µs)
t rr( µs)

trr Tj = Tjmax
0,5 -25 °C trr
0,4
Tj = Tjmax
-25 °C
0,4
trr

0,3
trr

0,3 Tj = 25 °C

0,2
Tj = 25 °C
0,2

0,1
0,1

0
0
0 25 50 75 100 125 150
0 5 10 15 20 25 I C (A) 30 R g on ( Ω )
T c=80°C
At At
Tj = 25/125 °C Tj = 25/125 °C
V CE = 300 V VR= 300 V
V GE = 15 V IF= 15 A
R gon = 32 Ω V GE = 15 V

copyright Vincotech 6 03 Aug. 2016 / Revision 2

 V23990-K203-B-PM
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Inverter Switch / Brake Switch / Inverter Diode / Brake Diode

figure 13. FWD figure 14. FWD

Typical reverse recovery charge as a Typical reverse recovery charge as a
function of collector current function of IGBT turn on gate resistor
Q rr = f(I C) Q rr = f(R gon)

2,4 1,6
Tj = Tjmax
Qrr( µC)

Qrr( µC)
-25 °C
Qrr
2 Qrr
Tj = Tjmax
-25 °C T c=80°C 1,2

1,6

Qrr Tj = 25 °C
1,2 0,8 Qrr
T c=80°C
Tj = 25 °C

0,8

0,4

0,4

0 0
I C (A) R g on ( Ω) 150
At 0
5 10 15 20 25 30 0 25 50 75 100 125

At At
Tj = 25/125 °C Tj = 25/125 °C
V CE = 300 V VR= 300 V
V GE = 15 V IF= 15 A
R gon = 32 Ω V GE = 15 V

figure 15. FWD figure 16. FWD

Typical reverse recovery current as a Typical reverse recovery current as a
function of collector current function of IGBT turn on gate resistor
I RRM = f(I C) I RRM = f(R gon)
12 12
Tj = Tjmax
IrrM (A)

IrrM (A)

- 25 °C
Tj = Tjmax
10
- 25°C
Tj = 25 °C IRRM
IRRM 9

8 IRRM
Tj = 25 °C
IRRM

6 6

0 0
0 5 10 15 20 25 I C (A) 30 0 30 60 90 120 R gon ( Ω ) 150

At At
Tj = 25/125 °C Tj = 25/125 °C
V CE = 300 V VR= 300 V
V GE = 15 V IF= 15 A
R gon = 32 Ω V GE = 15 V

copyright Vincotech 7 03 Aug. 2016 / Revision 2

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Inverter Switch / Brake Switch / Inverter Diode / Brake Diode

figure 17. FWD figure 18. FWD

Typical rate of fall of forward Typical rate of fall of forward
and reverse recovery current as a and reverse recovery current as a
function of collector current function of IGBT turn on gate resistor
dI 0/dt ,dI rec/dt = f(I C) dI 0/dt ,dI rec/dt = f(R gon)
600 750
dI0/dt

direc / dt (A/ µs)

dI0/dt
direc / dt (A/µ s)

dIrec/dt
dIrec/dt
500
600

400

450

300

300

200

150
100

0 0
0 5 10 15 20 25 I C (A) 30 0 25 50 75 100 125 R gon ( Ω ) 150

At At
Tj = 25/125 °C Tj = 25/125 °C
V CE = 300 V VR= 300 V
V GE = 15 V IF= 15 A
R gon = 32 Ω V GE = 15 V

figure 19. IGBT figure 20. FWD

IGBT transient thermal impedance FWD transient thermal impedance
as a function of pulse width as a function of pulse width
Z th(j-s) = f(t p) Z th(j-s) = f(t p)
101 101
Zth(j-s) (K/W)
Zth(j-s) (K/W)

100 100

D = 0,5 D = 0,5
0,2 0,2
10-1 10-1
0,1 0,1
0,05 0,05
0,02 0,02
0,01 0,01
0,005 0,005
0,000 0,000
10-2 10-2
10-5 10-4 10-3 10-2 10-1 102 100 t p (s) 101 10-5 10-4 10-3 10-2 10-1 102 100 t p (s) 101

At At
D = tp/T D = tp/T
R th(j-s) = 1,81 K/W R th(j-s) = 2,51 K/W

IGBT thermal model values FWD thermal model values

R (K/W) Tau (s) R (K/W) Tau (s)

4,79E-02 6,42E+00 5,06E-02 9,02E+00
2,09E-01 5,50E-01 2,53E-01 6,56E-01
7,40E-01 1,07E-01 8,83E-01 1,18E-01
5,03E-01 1,63E-02 7,35E-01 2,86E-02
1,67E-01 2,67E-03 3,35E-01 4,82E-03
1,40E-01 2,31E-04 2,57E-01 6,88E-04

copyright Vincotech 8 03 Aug. 2016 / Revision 2

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Inverter Switch / Brake Switch / Inverter Diode / Brake Diode

figure 21. IGBT figure 22. IGBT

Power dissipation as a Collector current as a
function of heatsink temperature function of heatsink temperature
P tot = f(T s) I C = f(T s)
100 21
Ptot (W)

Ic (A)
18
80

15

60
12

9
40

20
3

0 0
0 50 100 150 T s ( o C) 200 0 50 100 150 T s ( o C) 200

At At
Tj = 175 °C Tj = 175 °C
V GE = 15 V

figure 23. FWD figure 24. FWD

Power dissipation as a Forward current as a
function of heatsink temperature function of heatsink temperature
P tot = f(T s) I F = f(T s)
80 21
IF (A)
Ptot (W)

18

60
15

12

40

6
20

0 0
0 50 100 150 T s ( o C) 200 0 50 100 150 T s ( o C) 200

At At
Tj = 175 °C Tj = 175 °C

copyright Vincotech 9 03 Aug. 2016 / Revision 2

 V23990-K203-B-PM
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Inverter Switch / Brake Switch / Inverter Diode / Brake Diode

figure 25. IGBT figure 26. IGBT

Safe operating area as a function Gate voltage vs Gate charge
of collector-emitter voltage
I C = f(V CE) V GE = f(Q g)
103 20

VGE (V)
IC (A)

10uS 17,5

100uS 120 V
102 15

1mS
12,5
480 V
10mS
101 10
100mS

7,5
DC

5
100

2,5

0
10-1 0 0 30 60 90 120
10
101 102 V CE (V) 103 Q g (nC)

At At
D = single pulse IC = 15 A
Ts = 80 ºC
V GE = 15 V
Tj = T jmax

copyright Vincotech 10 03 Aug. 2016 / Revision 2

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Rectifier Diode

figure 1. Rectifier Diode figure 2. Rectifier Diode

Typical diode forward current as Diode transient thermal impedance
a function of forward voltage as a function of pulse width
I F = f(V F) Z th(j-s) = f(t p)
50 101

Zth(j-s) (K/W)
IF (A)

40

100
30

Tj = 25 °C
20
Tj = Tjmax- 25 °C
D = 0,5
0,2
10-1
0,1
0,05
10
0,02
0,01
0,005
0 0,000
0 0,5 1 1,5 2 V F (V) 2,5 10-2 t p (s)
10-5 10-4 10-3 10-2 10-1 100 10110
At At
tp = 250 µs D = tp/T
R th(j-s) = 1,51 K/W

figure 3. Rectifier Diode figure 4. Rectifier Diode

Power dissipation as a Forward current as a
function of heatsink temperature function of heatsink temperature
P tot = f(T s) I F = f(T s)
100 50
Ptot (W)

IF (A)

80 40

60 30

40 20

20 10

0 0
0 30 60 90 120 T s ( o C) 150 0 30 60 90 120 T s ( o C) 150

At At
Tj = 150 ºC Tj = 150 ºC

copyright Vincotech 11 03 Aug. 2016 / Revision 2

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Thermistor

figure 1. Thermistor
Typical PTC characteristic
as a function of temperature
R = f(T )
PTC-typical temperature characteristic
2000
R(Ω)

1800

1600

1400

1200

1000
25 50 75 100 T (°C) 125

copyright Vincotech 12 03 Aug. 2016 / Revision 2

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Switching Definitions Output Inverter

General conditions
Tj = 150 °C
R gon = 16 Ω
R goff = 8Ω

figure 1. IGBT figure 2. IGBT

Turn-off Switching Waveforms & definition of t doff, t Eoff Turn-on Switching Waveforms & definition of t don, t Eon
(t E off = integrating time for E off) (t E on = integrating time for E on)

140 250
%
% IC
120 tdoff
VCE 200
100
VGE 90% VCE 90%
80 150
IC
60 VCE
100
tEoff
40
tdon VGE
20 50
IC 1%
0 VCE 3%
VGE10% IC10%
VGE 0
-20
tEon
-40
-50
-0,2 0 0,2 0,4 0,6
2,75 2,8 2,85 2,9 2,95 3 3,05 3,1
time (µs) time(µs)

V GE (0%) = 0 V V GE (0%) = 0 V
V GE (100%) = 15 V V GE (100%) = 15 V
V C (100%) = 300 V V C (100%) = 300 V
I C (100%) = 10 A I C (100%) = 10 A
t doff = 0,12 µs t don = 0,01 µs
t E off = 0,51 µs t E on = 0,12 µs

figure 3. IGBT figure 4. IGBT

Turn-off Switching Waveforms & definition of t f Turn-on Switching Waveforms & definition of t r
120 240
fitted
% VCE % Ic
IC
100 210

IC 90% Tc=80°C
180
80

150
60 IC 60%

120
VCE
40 IC 40%
90
IC90%
20 tr
60
IC10%
0 tf 30
IC10%
-20 0
0,05 0,1 0,15 0,2 0,25 2,8 2,85 2,9 2,95 3
time (µs) time(µs)

V C (100%) = 300 V V C (100%) = 300 V

I C (100%) = 10 A I C (100%) = 10 A
tf = 0,03 µs tr = 0,01 µs

copyright Vincotech 13 03 Aug. 2016 / Revision 2

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Switching Definitions Output Inverter

figure 5. IGBT figure 6. IGBT

Turn-off Switching Waveforms & definition of t Eoff Turn-on Switching Waveforms & definition of t Eon
120 220
% Pon
IC 1% Eoff %
Poff
100
180

80
140

60 Eon
100

40

60
20

VGE 90%
20 Uce3%
0 Uge10%
tEoff tEon

-20 -20
-0,05 0,1 0,25 0,4 0,55 0,7 2,8 2,85 2,9 2,95 3 3,05
time (µs) time(µs)

P off (100%) = 2,97 kW P on (100%) = 2,97 kW

E off (100%) = 0,20 mJ E on (100%) = 0,21 mJ
t E off = 0,51 µs t E on = 0,12 µs

figure 7. IGBT
Turn-off Switching Waveforms & definition of t rr
150
%
Id
100

trr
50

Vd fitted
0
IRRM10%

-50

-100
IRRM90%
IRRM100%

-150
2,8 2,9 3 3,1 3,2
time(µs)

V d (100%) = 300 V
I d (100%) = 10 A
I RRM (100%) = 12 A
t rr = 0,22 µs

copyright Vincotech 14 03 Aug. 2016 / Revision 2

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Switching Definitions Output Inverter

figure 8. FWD figure 9. FWD

Turn-on Switching Waveforms & definition of t Qrr Turn-on Switching Waveforms & definition of t Erec
(t Q rr = integrating time for Q rr) (t Erec= integrating time for E rec)
150 120
%
% Erec
Id Qrr
100
100

tQrr 80
tErec
50

60
0
40

-50
20

Prec
-100
0

-150 -20
2,7 2,9 3,1 3,3 3,5 3,7 2,7 2,9 3,1 3,3 3,5 3,7
time(µs) time(µs)

I d (100%) = 10 A P rec (100%) = 2,97 kW

Q rr (100%) = 1,02 µC E rec (100%) = 0,22 mJ
t Q rr = 0,60 µs t E rec = 0,60 µs

copyright Vincotech 15 03 Aug. 2016 / Revision 2

 V23990-K203-B-PM
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Ordering Code & Marking

Version Ordering Code
with std lid (black V23990-K12-T-PM) V23990-K203-B-/0A/-PM
with std lid (black V23990-K12-T-PM) and P12 V23990-K203-B-/1A/-PM
with thin lid (white V23990-K13-T-PM) V23990-K203-B-/0B/-PM
with thin lid (white V23990-K13-T-PM) and P12 V23990-K203-B-/1B/-PM
VIN Date code Name&Ver UL Lot Serial
VIN WWYY Text
NNNNNNNVV UL VIN WWYY NNNNNNVV UL LLLLL SSSS
LLLLL SSSS
Type&Ver Lot number Serial Date code
Datamatrix
TTTTTTTVV LLLLL SSSS WWYY

Outline
Pad table [mm]
Pad X Y Function
1 15,93 -14,6 G5
2 15,93 -9,8 W
3 Not assembled
4 15,93 -0,2 +T
5 15,93 7,62 -T
6 15,93 12,62 G6
7 15,93 15,8 -DC/W
8 Not assembled
9 8,23 12,62 G4
10 8,23 15,8 -DC/V
11 7,73 -14,6 G3
12 7,73 -9,8 V
13 Not assembled
14 Not assembled
15 0,53 12,62 G2
16 0,53 15,8 -DC/U
17 -0,47 -14,6 G1
18 -0,47 -9,8 U
19 -5,47 -5 +B
20 -5,47 5,35 B
21 -7,17 12,62 GB
22 -7,17 15,8 -B
23 Not assembled
24 -8,07 -9,8 +DC
25 -15,02 -15,8 +RECT
26 Not assembled
27 -15,02 0 L2
28 -15,02 9,8 L1
29 -15,02 15,8 -RECT
Pad positions refers to center point. For more informations on pad design please see package data.

copyright Vincotech 16 03 Aug. 2016 / Revision 2

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Pinout

Identification
ID Component Voltage Current Function Comment

D8, D9, D10, D11 Rectifier 1600 V 25 A Rectifier Diode

T1-T6 IGBT 600 V 15 A Inverter Switch
D1-D6 FWD 600 V 20 A Inverter Diode
T7 IGBT 600 V 15 A Brake Switch
D7 FWD 600 V 20 A Brake Diode
PTC1 PTC Thermistor

copyright Vincotech 17 03 Aug. 2016 / Revision 2

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Packaging instruction
Standard packaging quantity (SPQ) 120 >SPQ Standard <SPQ Sample

Handling instruction
®
Handling instructions for MiniSkiiP 1 packages see vincotech.com website.

Package data
Package data for MiniSkiiP ® 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

V23990-K203-B-D2-14 03 Aug. 2016

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 18 03 Aug. 2016 / Revision 2