BTS640S2G Data Sheet (302 KB, EN)

Smart High-Side Power Switch
BTS640S2G
Smart Sense High-Side
Power Switch
Product Summary
Operating voltage
On-state resistance
Load current (ISO)
Current limitation
Features
5.0 ... 34
V
30 mΩ
12.6
A
24
A
Vbb(on)
RON
IL(ISO)
IL(SCr)
• Short circuit protection
• Current limitation
• Proportional load current sense
• CMOS compatible input
Package
• Open drain diagnostic output
• Fast demagnetization of inductive loads
TO220-7-11
TO263-7-2
TO220-7-12
• Undervoltage and overvoltage shutdown with
auto-restart and hysteresis
• Overload protection
• Thermal shutdown
1
1
1
Standard (staggered)
SMD
Straight
• Overvoltage protection including load dump (with
external GND-resistor)
• AEC qualified
• Reverse battery protection (with external GND-resistor)
• Green product (RoHS compliant)
• Loss of ground and loss of Vbb protection
• Electrostatic discharge (ESD) protection
Application
• µC compatible power switch with diagnostic feedback for 12 V and 24 V DC grounded loads
• All types of resistive, inductive and capacitve loads
• Replaces electromechanical relays, fuses and discrete circuits
General Description
N channel vertical power FET with charge pump, ground referenced CMOS compatible input and diagnostic

feedback, proportional sense of load current, monolithically integrated in Smart SIPMOS technology.
Providing embedded protective functions.
Block Diagram
9 EE
9ROWDJH
2YHUYROWDJH
&XUUHQW
*DWH
VRXUFH
SURWHFWLRQ
OLPLW
SURWHFWLRQ
9 /RJLF
,1
67
9ROWDJH
&KDUJHSXPS
VHQVRU
/HYHOVKLIWHU
5HFWLILHU
(6'
/RJLF
/LPLWIRU
XQFODPSHG
LQGORDGV
2XWSXW
9ROWDJH
GHWHFWLRQ
7HPSHUDWXUH
VHQVRU
,6
, ,6
5
,/
&XUUHQW
6HQVH
/RDG
5
2
*1'

352)(7
*1'
,6
287
/RDG*1'
6LJQDO*1'
Data Sheet
1
V1.1, 2008-19-08
Smart High-Side Power Switch
BTS640S2G
Pin
Symbol
1
ST
Function
Diagnostic feedback: open drain, invers to input level
2
GND
Logic ground
3
IN
Input, activates the power switch in case of logical high signal
4
Vbb
5
IS
Positive power supply voltage, the tab is shorted to this pin
Sense current output, proportional to the load current, zero in
the case of current limitation of load current
6&7
OUT
(Load, L)
Output, protected high-side power output to the load.
Both output pins have to be connected in parallel for operation
according this spec (e.g. kILIS).
Design the wiring for the max. short circuit current
Maximum Ratings at Tj = 25 °C unless otherwise specified
Parameter
Supply voltage (overvoltage protection see page 4)
Supply voltage for full short circuit protection
Symbol
Vbb
Vbb
Values
43
34
Unit
V
V
60
V
self-limited
-40 ...+150
-55 ...+150
85
A
°C
0,41
3,5
1.0
4.0
8.0
J
Tj Start=-40 ...+150°C
Load dump protection1) VLoadDump = VA + Vs, VA = 13.5V
VLoad dump3)
Load current (Short circuit current, see page 5)
Operating temperature range
Storage temperature range
Power dissipation (DC), TC ≤ 25 °C
Inductive load switch-off energy dissipation, single pulse
IL
Tj
Tstg
Ptot
RI2)= 2 Ω, RL= 1 Ω, td= 200 ms, IN= low or high
Vbb = 12V, Tj,start = 150°C, TC = 150°C const.
IL = 12.6 A, ZL = 4,2 mH, 0 Ω: EAS
IL = 4 A, ZL = 330 mH, 0 Ω: EAS
Electrostatic discharge capability (ESD)
IN: VESD
(Human Body Model)
ST, IS:
out to all other pins shorted:
W
kV
acc. MIL-STD883D, method 3015.7 and ESD assn. std. S5.1-1993
R=1.5kΩ; C=100pF
VIN
IIN
IST
IIS
Input voltage (DC)
Current through input pin (DC)
Current through status pin (DC)
Current through current sense pin (DC)
-10 ... +16
±2.0
±5.0
±14
V
mA
see internal circuit diagrams page 8
1)
2)
3)
Supply voltages higher than Vbb(AZ) require an external current limit for the GND and status pins (a 150 Ω
resistor in the GND connection is recommended).
RI = internal resistance of the load dump test pulse generator
VLoad dump is setup without the DUT connected to the generator according to ISO 7637-1 and DIN 40839
Data Sheet
2
V1.1, 2008-19-08
Smart High-Side Power Switch
BTS640S2G
Thermal Characteristics
Parameter and Conditions
Thermal resistance
Symbol
chip - case: RthJC
junction - ambient (free air): RthJA
SMD version, device on PCB4):
min
----
Values
typ
max
-- 1.47
-75
33
--
Unit
K/W
Electrical Characteristics
Parameter and Conditions
Symbol
at Tj = 25 °C, Vbb = 12 V unless otherwise specified
Values
min
typ
max
Unit
Load Switching Capabilities and Characteristics
On-state resistance (pin 4 to 6&7)
Tj=25 °C: RON
Tj=150 °C:
--
27
54
30
60
mΩ
--
50
--
mV
11.4
12.6
--
A
IL(NOM)
IL(GNDhigh)
4.0
--
4.5
--
-8
A
mA
9; not subject to production test, specified by design
Turn-on time
IN
to 90% VOUT:
Turn-off time
IN
to 10% VOUT:
RL = 12 Ω, Tj =-40...+150°C
ton
toff
25
25
70
80
150
200
µs
Slew rate on
dV /dton
0.1
--
1
V/µs
-dV/dtoff
0.1
--
1
V/µs
IL = 5 A
Output voltage drop limitation at small load
currents (pin 4 to 6&7), see page 14
IL = 0.5 A
VON(NL)
Tj =-40...+150°C:
Nominal load current, ISO Norm (pin 4 to 6&7)
IL(ISO)
VON = 0.5 V, TC = 85 °C
Nominal load current, device on PCB4)
TA = 85 °C, Tj ≤ 150 °C VON ≤ 0.5 V,
Output current (pin 6&7) while GND disconnected
or GND pulled up, Vbb=30 V, VIN= 0, see diagram page
10 to 30% VOUT, RL = 12 Ω, Tj =-40...+150°C
Slew rate off
70 to 40% VOUT, RL = 12 Ω, Tj =-40...+150°C
4)
Device on 50mm*50mm*1.5mm epoxy PCB FR4 with 6cm2 (one layer, 70µm thick) copper area for Vbb
connection. PCB is vertical without blown air.
Data Sheet
3
V1.1, 2008-19-08
Smart High-Side Power Switch
BTS640S2G
Parameter and Conditions
at Tj = 25 °C, Vbb = 12 V unless otherwise specified
Symbol
Values
min
typ
max
Operating Parameters
Operating voltage 5)
Undervoltage shutdown
Undervoltage restart
5.0
3.2
--
--4.5
34
5.0
5.5
6.0
V
V
V
----
4.7
-0.5
6.5
7.0
--
V
34
33
-41
43
--1
-47
43
---52
V
V
V
V
----
4
12
--
15
25
10
µA
--
1.2
3
mA
Vbb(on)
Tj =-40...+150°C: Vbb(under)
Tj =-40...+25°C: Vbb(u rst)
Tj =+150°C:
Undervoltage restart of charge pump
see diagram page 13
Tj =-40...+25°C: Vbb(ucp)
Tj =25...150°C:
Undervoltage hysteresis
∆Vbb(under)
Tj =-40...+150°C:
Unit
V
∆Vbb(under) = Vbb(u rst) - Vbb(under)
Overvoltage shutdown
Overvoltage restart
Overvoltage hysteresis
Overvoltage protection6)
Ibb=40 mA
Vbb(over)
Tj =-40...+150°C: Vbb(o rst)
Tj =-40...+150°C: ∆Vbb(over)
Tj =-40°C: Vbb(AZ)
Tj =+25...+150°C
Tj =-40...+150°C:
Standby current (pin 4)
Tj=-40...+25°C: Ibb(off)
Tj= 150°C:
IL(off)
Off state output current (included in Ibb(off))
VIN=0
VIN=0,
Operating current (Pin 2)7), VIN=5 V
5)
6)
7)
µA
Tj =-40...+150°C:
IGND
At supply voltage increase up to Vbb= 4.7 V typ without charge pump, VOUT ≈Vbb - 2 V
Supply voltages higher than Vbb(AZ) require an external current limit for the GND and status pins (a 150 Ω
resistor in the GND connection is recommended). See also VON(CL) in table of protection functions and
circuit diagram page 9.
Add IST, if IST > 0, add IIN, if VIN>5.5 V
Data Sheet
4
V1.1, 2008-19-08
Smart High-Side Power Switch
BTS640S2G
Parameter and Conditions
Symbol
at Tj = 25 °C, Vbb = 12 V unless otherwise specified
Protection Functions8)
Initial peak short circuit current limit (pin 4 to 6&7)
IL(SCp)
Tj =-40°C:
Tj =25°C:
Tj =+150°C:
Repetitive short circuit shutdown current limit
IL(SCr)
Tj = Tjt (see timing diagrams, page 12)
Output clamp (inductive load switch off)
at VOUT = Vbb - VON(CL); IL= 40 mA,
Tj =-40°C:
Tj =+25..+150°C:
Thermal overload trip temperature
Thermal hysteresis
Reverse battery (pin 4 to 2) 9)
VON(CL)
Tjt
∆Tjt
-Vbb
Reverse battery voltage drop (Vout > Vbb)
IL = -5 A
Tj=150 °C: -VON(rev)
Values
min
typ
max
Unit
48
40
31
56
50
37
65
58
45
A
--
24
--
A
41
43
150
---
-47
-10
--
-52
--32
V
°C
K
V
--
600
--
mV
4550
3300
5000
5000
6000
8000
4550
4000
5000
5000
5550
6500
5.4
6.1
6.9
V
0
0
0
----
1
15
10
µA
Diagnostic Characteristics
Current sense ratio10), static on-condition,
VIS = 0...5 V, Vbb(on) = 6.511)...27V,
Tj = -40°C, IL = 5 A:
kILIS = IL / IIS
kILIS
Tj= -40°C, IL= 0.5 A:
Tj= 25...+150°C, IL= 5 A:
,
Tj= 25...+150°C, IL = 0.5 A:
Current sense output voltage limitation
Tj = -40 ...+150°C
IIS = 0, IL = 5 A:
VIS(lim)
Current sense leakage/offset current
Tj = -40 ...+150°C
VIN=0, VIS = 0, IL = 0: IIS(LL)
VIN=5 V, VIS = 0, IL = 0: IIS(LH)
VIN=5 V, VIS = 0, VOUT = 0 (short circuit): IIS(SH)12 )
8)
9)
10)
11)
12)
Integrated protection functions are designed to prevent IC destruction under fault conditions described in the
data sheet. Fault conditions are considered as "outside" normal operating range. Protection functions are not
designed for continuous repetitive operation.
Requires 150 Ω resistor in GND connection. The reverse load current through the intrinsic drain-source
diode has to be limited by the connected load. Note that the power dissipation is higher compared to normal
operating conditions due to the voltage drop across the intrinsic drain-source diode. The temperature
protection is not active during reverse current operation! Input and Status currents have to be limited (see
max. ratings page 2 and circuit page 9).
This range for the current sense ratio refers to all devices. The accuracy of the kILIS can be raised at least by
a factor of two by matching the value of kILIS for every single device.
In the case of current limitation the sense current IIS is zero and the diagnostic feedback potential VST is
High. See figure 2b, page 11.
Valid if Vbb(u rst) was exceeded before.
not subject to production test, specified by design
Data Sheet
5
V1.1, 2008-19-08
Smart High-Side Power Switch
BTS640S2G
BTS 640 S2
Parameter and Conditions
Symbol
at Tj = 25 °C, Vbb = 12 V unless otherwise specified
Current sense settling time to IIS static±10% after
5 A,
positive input slope13) , IL = 0
Values
min
typ
max
Unit
tson(IS)
--
--
300
µs
Current sense settling time to 10% of IIS static after
negative input slope13) , IL = 5
0A,
tsoff(IS)
--
30
100
µs
--
10
--
µs
2
3
4
V
5
15
40
kΩ
3,0
4,5
7,0
kΩ
-1.5
--
--0.5
3.5
---
V
V
V
1
--
50
µA
20
50
90
µA
td(ST OL3)
--
400
--
µs
tdon(ST)
--
13
--
µs
tdoff(ST)
--
1
--
µs
5.4
----
6.1
----
6.9
0.4
0.7
2
V
Tj= -40...+150°C
Tj= -40...+150°C
Current sense rise time (60% to 90%) after change
of load current13) , IL = 2.5
5A
tslc(IS)
Open load detection voltage14) (off-condition)
VOUT(OL)
Tj=-40..150°C:
Internal output pull down
RO
(pin 6 to 2), VOUT=5 V, Tj=-40..150°C
Input and Status Feedback15)
Input resistance
RI
see circuit page 8
Input turn-on threshold voltage
Tj =-40..+150°C: VIN(T+)
Input turn-off threshold voltage
Tj =-40..+150°C: VIN(T-)
Input threshold hysteresis
∆ VIN(T)
Off state input current (pin 3), VIN = 0.4 V
Tj =-40..+150°C IIN(off)
On state input current (pin 3), VIN = 5 V
Tj =-40..+150°C
IIN(on)
Delay time for status with open load
after Input neg. slope (see diagram page 13)
Status delay after positive input slope13)
Tj=-40 ... +150°C:
Status delay after negative input
slope13)
Tj=-40 ... +150°C:
Status output (open drain)
Zener limit voltage Tj =-40...+150°C, IST = +1.6 mA: VST(high)
Tj =-40...+25°C, IST = +1.6 mA: VST(low)
ST low voltage
Tj = +150°C, IST = +1.6 mA:
Status leakage current, VST = 5 V,
Tj=25 ... +150°C: IST(high)
µA
13)
not subject to production test, specified by design
External pull up resistor required for open load detection in off state.
15) If a ground resistor R
GND is used, add the voltage drop across this resistor.
14)
Data Sheet
6
V1.1, 2008-19-08
Smart High-Side Power Switch
BTS640S2G
Truth Table
Normal
operation
Currentlimitation
Short circuit to
GND
Overtemperature
Short circuit to
Vbb
Open load
Undervoltage
Overvoltage
Negative output
voltage clamp
L = "Low" Level
H = "High" Level
16)
17)
18)
19)
20)
Input
Output
Status
Current
Sense
level
level
level
IIS
L
H
L
H
L
H
L
H
L
H
L
H
L
H
L
H
L
L
H
L
H
L
L16)
L
L
H
H
H
L
H
H
H
H
H
H
L17)
L
H (L20))
L
H
L
H
L
H
0
nominal
0
0
0
0
0
0
0
<nominal 18)
0
0
0
0
0
0
0
L19)
H
L
L
L
L
L
X = don't care
Z = high impedance, potential depends on external circuit
Status signal after the time delay shown in the diagrams (see fig 5. page 12...13)
The voltage drop over the power transistor is Vbb-VOUT>typ.3V. Under this condition the sense current IIS is
zero
An external short of output to Vbb, in the off state, causes an internal current from output to ground. If RGND
is used, an offset voltage at the GND and ST pins will occur and the VST low signal may be errorious.
Low ohmic short to Vbb may reduce the output current IL and therefore also the sense current IIS.
Power Transistor off, high impedance
with external resistor between pin 4 and pin 6&7
Data Sheet
7
V1.1, 2008-19-08
Smart High-Side Power Switch
BTS640S2G
Status output
Terms
9
9
EE
, ,1
, 67
9
,1
, ,6
,EE
921
9EE
,1
287
5 6721
,/
67
352)(7
67
287
,6
967
9
,6
*1'
5
*1'
9
(6'
='
*1'
287
,
*1'
ESD-Zener diode: 6.1 V typ., max 5 mA;
RST(ON) < 440 Ω at 1.6 mA, The use of ESD zener
diodes as voltage clamp at DC conditions is not
recommended.
Input circuit (ESD protection)
,1
5
Current sense output
,
(6'=' ,
,
9
,6
,
,6
,
,6
*1'
(6'='
The use of ESD zener diodes as voltage clamp at DC
conditions is not recommended.
5
,6
*1'
ESD-Zener diode: 6.1 V typ., max 14 mA;
RIS = 1 kΩ nominal
Inductive and overvoltage output clamp
9 EE
9
=
921
287
*1'
352)(7
VON clamped to 47 V typ.
Data Sheet
8
V1.1, 2008-19-08
Smart High-Side Power Switch
BTS640S2G
Overvoltage protection of logic part
GND disconnect
9
9 EE
5 67
9
5,
,1
9
EE
=
67
/RJLF
,6
59
9
5 ,6
,EE
,1
9EE
67
352)(7
287
287
,6
*1'
=
9 9 9
,1 67 ,6
*1'
5 *1'
9
*1'
Any kind of load. In case of Input=high is VOUT ≈ VIN - VIN(T+) .
6LJQDO*1'
Due to VGND >0, no VST = low signal available.
VZ1 = 6.1 V typ., VZ2 = 47 V typ., RI= 4 kΩ typ,
RGND= 150 Ω, RST= 15 kΩ, RIS= 1 kΩ, RV= 15 kΩ,
GND disconnect with GND pull up
Reverse battery protection
9
9EE
5 67
5,
,1
/RJLF
67
9EE
67
352)(7
287
287
,6
*1'
9=
,6
,1
287
9
EE
3RZHU
,QYHUVH
'LRGH
59
5 ,6
9
*1'
Any kind of load. If VGND > VIN - VIN(T+) device stays off
Due to VGND >0, no VST = low signal available.
*1'
5/
5*1'
3RZHU*1'
6LJQDO*1'
9 9679
,1
,6
Vbb disconnect with energized inductive
load
The load RL is inverse on, temperature protection is
not active
RGND= 150 Ω, RI= 4 kΩ typ, RST≥ 500 Ω, RIS≥ 200 Ω,
RV≥ 500 Ω,
KLJK
Open-load detection
5
67
352)(7
287
287
,6
*1'
9
EE
EE
(;7
9EE
OFF-state diagnostic condition: VOUT > 3 V typ.; IN low
9
,1
Normal load current can be handled by the PROFET
itself.
2))
2XW
67
/RJLF
5
9
287
2
6LJQDO*1'
Data Sheet
9
V1.1, 2008-19-08
Smart High-Side Power Switch
BTS640S2G
Vbb disconnect with charged external
inductive load
KLJK
9EE
,1
287
67
352)(7
'
287
,6
*1'
5/
/
9
EE
If other external inductive loads L are connected to the PROFET,
additional elements like D are necessary.
Inductive Load switch-off energy
dissipation
( EE
( $6
9EE
,1
67
,6
( /RDG
9EE
287
352)(7
287
(/
*1'
(5
Energy stored in load inductance:
EL =
1/ ·L·I 2
2
L
While demagnetizing load inductance, the energy
dissipated in PROFET is
EAS= Ebb + EL - ER=
VON(CL)·iL(t) dt,
with an approximate solution for RL > 0 Ω:
EAS=
Data Sheet
IL· L
·(Vbb + |VOUT(CL)|)·
2·RL
OQ(1+ |V
IL·RL
OUT(CL)|
)
10
V1.1, 2008-19-08
Smart High-Side Power Switch
BTS640S2G
Figure 2a: Switching a lamp
Timing diagrams
,1
Figure 1a: Switching a resistive load,
change of load current in on-condition:
67
,1
67
9
W don(ST)
9287
W on
,/
W off
Wslc(IS)
,/
287
W doff(ST)
W slc(IS)
, ,6
/RDG
,,6
W son(IS)
W
/RDG
W soff(IS)
W
Figure 2b: Switching a lamp with current limit:
,1
The sense signal is not valid during settling time after turn or
change of load current.
67
Figure 1b: Vbb turn on:
,1
9287
9EE
,/
,
/
,,6
W
, ,6
67
W
t
Data Sheet
d
ll
diti
11
V1.1, 2008-19-08
Smart High-Side Power Switch
BTS640S2G
Figure 4a: Overtemperature:
Reset if Tj <Tjt
Figure 2c: Switching an inductive load:
,1
,1
67
67
9287
,/
,/
, ,6
,,6
7W
W
Figure 3a: Short circuit:
shut down by overtempertature, reset by cooling
Figure 5a: Open load: detection in ON-state,
open load occurs in on-state
,1
,/
,1
,/6&S
,
67
/6&U
9287
, ,6
,/
67
RSHQ
QRUPDO
W
,,6
Heating up may require several milliseconds, depending on
external conditions
IL(SCp) = 50 A typ. increases with decreasing temperature.
Data Sheet
QRUPDO
12
W
V1.1, 2008-19-08
Smart High-Side Power Switch
BTS640S2G
Figure 6b: Undervoltage restart of charge pump
Figure 5b: Open load: detection in ON- and OFF-state
(with REXT), turn on/off to open load
921&/
9 RQ
,1
RQVWDWH
RIIVWDWH
67
9
RIIVWDWH
WG672/
EERYHU
9
287
9
9
EEXUVW
9
,
/
9
RSHQORDG
EERUVW
EEXFS
EEXQGHU
9 EE
, ,6
W
charge pump starts at Vbb(ucp) =4.7 V typ.
Figure 7a: Overvoltage:
Figure 6a: Undervoltage:
,1
,1
67
QRWGHILQHG
67
9bb
VON(CL)
V
bb(over)
V
bb(o rst)
9
EE
V
bb(under)
,
Vbb(u cp)
9bb(u rst)
,/
/
,
,,6
Data Sheet
,6
W
W
13
V1.1, 2008-19-08
Smart High-Side Power Switch
BTS640S2G
Figure 8b: Current sense ratio21:
Figure 8a: Current sense versus load current:
>P$@
N ,/,6
, ,6
,/
>$@ , /
>$@ Figure 9a: Output voltage drop versus load current:
921
>9@
521
9211/
,/
21
Data Sheet
14
>$@ This range for the current sense ratio refers to all
devices. The accuracy of the kILIS can be raised at
least by a factor of two by matching the value of
kILIS for every single device.
V1.1, 2008-19-08
Smart High-Side Power Switch
BTS640S2G
Package Outlines
4.4
7.5
B
0.05
6.5
4.7 ±0.5
1±0.3
6.6
9.2 ±0.2
(14.9)
10.2 ±0.15
1.3 +0.1
-0.02
A
2.7 ±0.5
9.9
1)
0.1
17
0...0.15
7x
2.4
0.5 ±0.15
0.6 +0.1
-0.03
6 x 1.27
8° M
AX.
0.25
M
AB
0.1 B
1) Shear and punch direction no burrs this surface
Back side, heatsink contour
All metal sufaces tin plated, except area of cut .
Figure 1
PG-TO-263-7-2 (Plastic Dual Small Outline Package) (RoHS-compliant)
To meet the world-wide customer requirements for environmentally friendly products and to be compliant with
government regulations the device is available as a green product. Green products are RoHS-Compliant (i.e Pbfree finish on leads and suitable for Pb-free soldering according to IPC/JEDEC J-STD-020).
Please specify the package needed (e.g. green package) when placing an order
You can find all of our packages, sorts of packing and others in our
Infineon Internet Page “Products”: http://www.infineon.com/products.
Data Sheet
15
Dimensions in mm
V1.1, 2008-19-08
Smart High-Side Power Switch
BTS640S2G
Revision History
Version
V1.1
Data Sheet
Date
Changes
2008-19-08
Creation of the green datasheet.
First page :
Adding the green logo and the AEC qualified
Adding the bullet AEC qualified and the RoHS compliant features
Package page
Modification of the package to be green.
16
V1.1, 2008-19-08
Edition 2008-19-08
Published by
Infineon Technologies AG
81726 Munich, Germany
© Infineon Technologies AG 8/19/08.
All Rights Reserved.
Legal Disclaimer
The information given in this document shall in no event be regarded as a guarantee of conditions or
characteristics (“Beschaffenheitsgarantie”). With respect to any examples or hints given herein, any typical values
stated herein and/or any information regarding the application of the device, Infineon Technologies hereby
disclaims any and all warranties and liabilities of any kind, including without limitation warranties of
non-infringement of intellectual property rights of any third party.
Information
For further information on technology, delivery terms and conditions and prices please contact your nearest
Infineon Technologies Office (www.infineon.com).
Warnings
Due to technical requirements components may contain dangerous substances. For information on the types in
question please contact your nearest Infineon Technologies Office.
Infineon Technologies Components may only be used in life-support devices or systems with the express written
approval of Infineon Technologies, if a failure of such components can reasonably be expected to cause the failure
of that life-support device or system, or to affect the safety or effectiveness of that device or system. Life support
devices or systems are intended to be implanted in the human body, or to support and/or maintain and sustain
and/or protect human life. If they fail, it is reasonable to assume that the health of the user or other persons may
be endangered.
Similar pages