FAIRCHILD ILC6390

www.fairchildsemi.com
ILC6390/91
SOT-89 Step-Up PFM Switcher with Auto-Load Sense
Features
Description
•
•
•
•
•
50 mA boost converter using Pulse Frequency Modulation, or
PFM, technique, in 5-lead SOT-89 or a 5-lead SOT-23
package. Only 3 external components are needed to complete
the switcher design.
85% conversion efficiency at 50mA out
Start-up voltages as low as 900mV
±2.5% accurate outputs
Complete switch design with only 3 external components
Automatically senses load variations to select the optimal
duty cycle and extend conversion efficiency over a wide
range
• External transistor configuration to run as switcher
controller
• Shutdown to 0.5µA
Applications
The ILC6390 automatically senses load variations to choose
between 55% and 75% duty cycles. Normal operation is 55%
duty at 155kHz; when load currents exceed the internal
comparator trip point, a “turbo mode” kicks in to provide
extended on-time switching (75% duty at 100kHz
oscillation).
Requiring only 30µA of supply current, the ILC6390
achieves efficiencies as high as 85% at 5V yet shuts down to
0.5µA max.
• Cellular phones, pagers
• Cameras, video recorders
• Palmtops and PDAs
Standard voltages offered are 2.5, 3.3, and 5.0V and is
available in both a 5 lead SOT-23 and 5 lead SOT-89 package
for small footprint applications.
In addition, the ILC6391 is configured to drive an external
transistor to achieve higher power levels.
Typical Applications
Figures 1 & 2
CE
SD
3
L: 100µH (SUMIDA, CD-54)
1
SD: Diode (Schottky diode;
MATSUSHITA MA 735)
ILC6390CM
V IN
1
3
2
V OUT
+
SD
V
3
L
2
+
ILC6390CP
V IN
CL: 16V 47µF (Tantalum
Capacitor; NICHICON, f93)
4
CL
GND
Figures 3 & 4
CE
SD
V
3
2
1
L
+
ILC6391CM
V IN
4
5
CL
OUT
R
V
SD: Diode (Schottky diode;
MATSUSHITA MA735)
CL: 16V 47µF (Tantalum
Capacitor; NICHICON, F93)
RB: 1kΩ
CB: 3300pF
CE
SD
L: 47µH (SUMIDA, CD-54)
Tr
GND
CL
5
GND
CE
OUT
1
L
3
L
2
+
ILC6391CP
V IN
OUT
1
CL
CB
4
5
Tr
RB
GND
Tr: 2SC3279, 2SDI628G
Rev.1.2
©2001 Fairchild Semiconductor Corporation
ILC6390/91
Pin Assignments
LX
V SS
LX
V SS
5
4
5
4
SOT-25
SOT-25
(TOP VIEW)
(TOP VIEW)
1
2
3
1
2
3
CE
V DD
N/C
CE
VDD
N/C
ILC6391CM
ILC6390CM
V SS
LX
V SS
LX
5
4
5
4
SOT-89-5
SOT-89-5
(TOP VIEW)
(TOP VIEW)
1
2
3
1
2
3
N/C
VOUT
CE
N/C
V OUT
CE
ILC6390CP
ILC6391CP
Internal Block Diagram
V DD
LX
VLX LIMITER
VREF
BUFFER
V SS
2-STEP PFM
CONTROLLED OSC
100/155kHz
EXT
V OUT
+
+
CE
CHIP ENABLE
-
Absolute Maximum Ratings (
Parameter
A
4~5mV
= 25°C)
Symbol
Ratings
Units
VOUT Input Voltage
VOUT
12
V
Voltage on pin LX
VLX
12
V
ILX
400
mA
Voltage on pin EXT
VEXT
VSS-0.3~VOUT
+0.3
V
Current on pin EXT
IEXT
±50
mA
CE Input Voltage
VCE
12
V
Current on pin LX
VDD Input Voltage
VDD
12
V
PD (SOT-25)
PD(SOT-89)
150
500
mW
Operating Ambient Temperature
Topr
-30~+80
°C
Storage Temperature
Tstg
-40~+125
°C
Continuous Total Power Dissipation
©2001 Fairchild Semiconductor Corporation
2
ILC6390/91
Electrical Characteristics ILC6390
VOUT = 5.0V TA = 25°C. Unless otherwise specified, VIN = VOUT x 0.6, IOUT = 50mA. See schematic, fig. 1 & 2.
Parameter
Output Voltage
Input Voltage
Oscillation Startup Voltage
Oscillation Hold Voltage
NO-Load Input Current
Supply Current 1 (Note 2)
Supply Current 2
LX Switch-On Resistance
LX Leakage Current
Symbol
VOUT
VIN
VST
VHLD
IIN
IDD1
Duty Ratio 1
DUTY 1
Duty Ratio 2
DUTY 2
Maximum Oscillation Freq. 1
Maximum Oscillation Freq. 2
Stand = by Current
CE “High” Voltage
MFO 1
MFO 2
ISTB
VCEH
RSWON
ILXL
CE “Low” Voltage
VCEL
CE “High” Current
CE “Low” Current
LX Limit Voltage
ICEH
ICEL
VLXLMT
Efficiency
EFFI
Conditions
Test Circuit Figures 1 & 2
IOUT = 1mA
IOUT = 1mA
IOUT = 0mA (Note1)
VOUT = 4.75V
VOUT = 5.5V
VOUT = 4.75V, VLX = 0.4
No external components, VOUT = VLX
= 10V
VOUT = 4.75V, Measuring of LX
waveform
VOUT = 4.75V, Measuring of LX ontime
VOUT = 4.75V, 75% duty
VOUT = 4.75V, 55% duty
VOUT = 4.75V
VOUT = 4.75V, Existence of LX
Oscillation
VOUT = 4.75V, Disappearance of LX
Oscillation
VCE = VOUT x 0.95
VOUT = 4.75V, VCE = 0V
VOUT = 4.75V, fOSC > MFO x 2
(Note 3)
Test Circuit Figures 1 & 2
Min.
4.875
Typ.
5.000
5.3
31.7
2.4
2.8
10.6
63.4
4.8
4.3
1.0
Units
V
V
V
V
µA
µA
µA
Ω
µA
70
75
80
%
50
55
60
%
85
153
100
180
115
207
0.5
kHz
kHz
µA
V
0.20
V
0.25
-0.25
1.1
µA
µA
V
0.80
Max.
5.125
10
0.9
0.70
0.75
0.7
85
%
Note:
1. The Schottky diode (S.D.), in figure 3 must be type MA735, with Reverse current (IR) < 1.0µA at reverse voltage (VR)=10.0V
2. “Supply Current 1” is the supply current while the oscillator is continuously oscillating. In actual operation the oscillator
periodically operates which results in less average power consumption. The current that is actually provided by external V IN
source is represented by “No-Load Input Current.”
3. The switching frequency is determined by the delay time of the internal comparator and MFO1, which sets the min. on-time
©2001 Fairchild Semiconductor Corporation
3
ILC6390/91
Electrical Characteristics ILC6390
VOUT = 5.0V TA = 25°C. Unless otherwise specified, VIN = VOUT x 0.6, IOUT = 50mA. See schematic, fig. 3 & 4.
Parameter
Output Voltage
Symbol
VOUT
Conditions
Test Circuit Figures 3 & 4
Min.
Typ.
Max.
Units.
4.875
5.000
5.125
V
10
V
0.80
0.9
V
Input Voltage
VIN
Operation Startup Voltage
VST
IOUT = 1mA
Operation Hold Voltage
VST
IOUT = 1mA
Supply Current 1 (Note 1)
IDD 1
VOUT = 4.75V
31.7
63.4
µA
Supply Current 2
IDD 2
VOUT = 5.5V
2.4
4.8
µA
EXT “High” On-Resistance
REXTH
VOUT = 4.75V, VEXT = VOUT-0.4
50
75
Ω
EXT “Low” On-Resistance
REXTL
VOUT = 4.75V, VEXT = 0.4
50
75
Ω
0.70
V
Duty Ratio 1
DUTY 1
VOUT = 4.75V, Measuring of EXT
waveform
70
75
80
%
Duty Ratio
DUTY 2
VIN = VOUT x 0.95, IOUT = 1mA,
Measuring of EXT High State
50
55
60
%
Maximum Oscillation Freq. 1
MFO 1
VOUT = 4.75V, 75% duty
85
100
115
kHz
Maximum Oscillation Freq. 2
MFO 2
VIN = VOUT x 0.95, 55% duty
153
180
207
kHz
0.5
µA
Stand = by Current
ISTB
VOUT = 4.75V
CE “High” Voltage
VCEH
VOUT = 4.75V, Existence of EXT
Oscillation
CE “Low” Voltage
ICEL
VOUT = 4.75V, Disappearance of EXT
Oscillation
0.20
V
CE “High” Current
ICEH
VCE = VOUT = 4.75V
0.25
µA
VOUT = 4.75, VCE = 0V
-0.25
µA
CE “Low” Current
Efficiency
EFFI
Test Circuit Figures 3 & 4
0.75
V
85
%
Note:
1. “Supply Current 1” is the supply current while the oscillator is continuously oscillating. In actual operation the
oscillator periodically operates which results in less average power consumption.
©2001 Fairchild Semiconductor Corporation
4
ILC6390/91
The ILC6390 performs boost DC-DC conversion by controlling the switch element shown in the circuit below.
When the switch is closed, current is built up through the
inductor. When the switch opens, this current has to go
somewhere and is forced through the diode to the output. As
this on and off switching continues, the output capacitor
voltage builds up due to the charge it is storing from the
inductor current. In this way, the output voltage gets boosted
relative to the input. The ILC6390 monitors the voltage on
the output capacitor to determine how much and how often
to drive the switch.
In general, the switching characteristic is determined by the
output voltage desired and the current required by the load.
Specifically the energy transfer is determined by the power
stored in the coil during each switching cycle.
PL = ƒ(tON, VIN)
The ILC6390 and ILC6391 use a PFM or Pulse Frequency
Modulation technique. In this technique, the switch is always
turned on for a fixed period of time, corresponding to a fixed
switching frequency at a predefined duty cycle. For the
ILC6390 this value is 3.55msec on time, corresponding to
55% duty cycle at 155kHz. Because the inductor value,
capacitor size, and switch on-time and frequency are all
fixed, the ILC6390 in essence delivers the same amount of
power to the output during each switching cycle. This in turn
creates a constant output voltage ramp which is dependent
on the output load requirement. In this mode, the only difference between the PFM and PWM techniques is the duty
cycle of the switch.
Once the output voltage reaches the set point, the ILC6390
will shut off the switch oscillator and wait until the output
voltage drops low again, at which point it will re-start the
oscillator. As you can see in the diagram, the PFM boost
converter actually skips pulses as a way of varying the
amount of power being delivered to the output.
Switch Waveform
V SET
V OUT
Because of this, PFM is sometimes called “Pulse Skipping
Modulation.”
The chief advantage of using a PFM technique is that, at low
currents, the switcher is able to maintain regulation without
constantly driving a switch on and off. This power savings
can be 5mA or more for the ILC6390 versus the ILC6370,
and at very light loads this current difference can make a
noticeable impact on overall efficiency.
However, because the ILC6390 will skip pulses based on
load current, the effective frequency of switching may well
drop into the audio band. This means that the radiated noise
of the ILC6390 may interfere with the audio channel of the
system and additional filtering may be necessary. In addition, because the PFM on-time is fixed, it usually has higher
output ripple voltage than the PWM switcher, which dynamically changes the on-time to match the load current requirements. [Ripple is due to the output cap constantly accepting
and storing the charge received from the inductor, and delivering charge as required by the load. The “pumping” action
of the switch produces a sawtooth-shaped voltage as seen by
the output.]
On the plus side, because pulses are skipped, overtone content of the frequency noise is lower than in a PWM configuration. The sum of these characteristics for PFM converters
makes it the ideal choice for low-current or ultra-long runtime applications, where overall conversion efficiency at low
currents is of primary concern. [For other conversion techniques, please see the ILC6370/71 and ILC6380/81
datasheets.]
Dual-Step Mode
The ILC6390 and ILC6391 have one other unique feature,
that being to automatically switch to a second switching
scheme in the presence of heavy output loading. As we mentioned, the standard switching scheme for these parts is a
3.55msec, 155kHz, 55% duty cycle part. However, if the
device detects that the output load increases beyond a set
point (as seen by the voltage drop on the output capacitor), it
switches in a 7.5msec, 100kHz, 75% duty cycle “turbo
mode” specifically to keep up with the increased load
demand. This switchover is seamless to the user, but will
result in a change in the output ripple voltage characteristic
of the DC-DC converter.
PFM converters are widely used in portable consumer applications not requiring a high current level and relatively unaffected by audio noise. Applications such as pagers and
PDAs, which need to operate in stand-by for extended periods of time, gravitate toward the advantages of PFM since
maximum run-time is a chief differentiating element. The
ILC6390 addresses this low-current requirement, and additionally offers a “turbo” mode which maintains output regulation in the presence of heavier-than-normal load currents,
and maintains 0.5mA shutdown currents.
The only difference between the ILC6390 and ILC6391
parts is that the 6391 is configured to drive an external transistor as the switch element. Since larger transistors can be
selected for this element, higher effective loads can be regulated.
©2001 Fairchild Semiconductor Corporation
5
ILC6390/91
External Components and
Layout Consideration
The ILC6390 is designed to provide a complete DC-DC converter solution with a minimum of external components. Ideally, only three externals are required: the inductor, a pass
diode, and an output capacitor.
The inductor needs to be of low DC Resistance type, typically 1 Ω value. Toroidal wound inductors have better field
containment (less high frequency noise radiated out) but tend
to be more expensive. Some manufacturers like Coilcraft
have new bobbin-wound inductors with shielding included,
which may be an ideal fit for these applications. Contact the
manufacturer for more information.
The inductor size needs to be in the range of 47mH to 1mH.
In general, larger inductor sizes deliver less current, so the
load current will determine the inductor size used.
For load currents higher than 10mA, use an inductor from
47mH to 100mH. [The 100mH inductor shown in the
datasheet is the most typical used for this application.]
For load currents of around 5mA, such as pagers, use an
inductor in the range of 100mH to 330mH. 220mH is the
most typical value used here.
For lighter loads, an inductor of up to 1mH can be used. The
use of a larger inductor will increase overall conversion efficiency, due to the reduction in switching currents through the
device.
For the IL6391, much of the component selection is as
described above, with the addition of the external NPN transistor and the base drive network. The transistor needs to be
of NPN type, and should be rated for currents of 2A or more.
[This translates to lower effective on resistance and, therefore, higher overall efficiencies.] The base components
should remain at 1kΩ and 3300pF; any changes need to be
verified prior to implementation.
As for actual physical component layout, in general, the
more compact the layout is, the better the overall performance will be. It is important to remember that everything in
the circuit depends on a common and solid ground reference.
Ground bounce can directly affect the output regulation and
presents difficult behavior to predict. Keeping all ground
traces wide will eliminate ground bounce problems.
It is also critical that the ground pin of C L and the VSS pin of
the device be the same point on the board, as this capacitor
serves two functions: that of the output load capacitor, and
that of the input supply bypass capacitor.
Layouts for DC-DC converter designs are critical for overall
performance, but following these simple guidelines can simplify the task by avoiding some of the more common mistakes made in these cases. Once actual performance is
completed, though, be sure to double-check the design on
actual manufacturing prototype product to verify that nothing has changed which can affect the performance.
For the ILC6391, using an external transistor, the use of a
47mH inductor is recommended based on our experience
with the part.
The capacitor should, in general, always be tantalum type, as
tantalum has much better ESR and temperature stability than
other capacitor types. NEVER use electrolytics or chemical
caps, as the C-value changes below 0×C so much as to make
the overall design unstable.
Different C-values will directly impact the ripple seen on the
output at a given load current, due to the direct charge-tovoltage relationship of this element. Different C-values will
also indirectly affect system reliability, as the lifetime of the
capacitor can be degraded by constant high current influx
and outflux. Running a capacitor near its maximum rated
voltage can deteriorate lifetime as well; this is especially true
for tantalum caps which are particularly sensitive to overvoltage conditions.
In general, then, this capacitor should always be 47mF, Tantalum, 16V rating.
The diode must be of shottkey type for fast recovery and
minimal loss. A diode rated at greater than 200mA and maximum voltage greater than 30V is recommended for the fastest switching time and best reliability over time. Different
diodes may introduce different levels of high frequency
switching noise into the output waveform, so trying out several sources may make the most sense for your system.
©2001 Fairchild Semiconductor Corporation
6
ILC6390/91
Typical Performance Characteristics General conditions for all curves
Output Voltage vs Output Current
Efficiency vs. Output Current
ILC6390CP-30
4.0
100
3.5
80
3.0
VIN = 2.0V
2.5
VIN = 1.5V
VIN = 1.2V
VIN = 1.8V
2.0
VIN = 0.9V
EFFICIENCY: EFFI (%)
OUTPUT VOLTAGE: VOUT(V)
ILC6391CP-30
L = 100µH
C = 10µF (Tantalum)
VIN = 1.8V
60
VIN = 1.2V
VIN = 1.0V
40
L = 22µH (CD105)
RB = 300
CB = 0
20
1.5
0
1.0
0
100
200
300
500
400
OUTPUT CURRENT I OUT (mA)
0.5
0
20
40
60
100
80
OUTPUT CURRENT I OUT (mA)
Output Voltage vs. Output Current
Efficiency vs. Output Current
7.0
ILC6390CP-50
L = 100µH
C = 10µF (Tantalum)
ILC6390CP-30
6.0
L = 100µH
C = 10µF (Tantalum)
80
60
VIN = 0.9V
VIN = 1.2V
VIN = 1.5V
VIN = 1.8V
VIN = 2.0V
40
20
OUTPUT VOLTAGE: VOUT(V)
100
EFFICIENCY: EFFI (%)
VIN = 1.5V
5.0
VIN = 3.0V
4.0
3.0
VIN = 2.0V
VIN = 1.5V
2.0
VIN = 1.2V
VIN = 0.9V
1.0
0
0
0
20
40
60
80
100
0
20
OUTPUT CURRENT I OUT (mA)
80
100
Efficiency vs. Output Current
ILC6390CP-30
100
L = 100µH
C = 10µF (Tantalum)
80
ILC6390CP-50
80
60
EFFICIENCY: EFFI (%)
RIPPLE Vr (mV p-p)
60
OUTPUT CURRENT I OUT (mA)
Ripple Voltage vs. Output Current
100
40
VIN = 1.5V
40
VIN = 1.2V
20
VIN = 3.0V
60
VIN = 0.9V
VIN = 1.2V V = 1.5V
IN
VIN = 2.0V
40
20
VIN = 0.9V
L = 100µH
C = 10µF (Tantalum)
0
0
20
40
60
OUTPUT CURRENT I OUT (mA)
80
100
0
0
20
40
60
80
100
OUTPUT CURRENT I OUT (mA)
©2001 Fairchild Semiconductor Corporation
7
ILC6390/91
Typical Performance Characteristics General conditions for all curves
Ripple Voltage vs. Output Current
100
Output Voltage vs. Output Current
ILC6390CP-50
4.0
L = 100µH
C = 10µF (Tantalum)
3.5
OUTPUT VOLTAGE: VOUT(V)
80
RIPPLE Vr (mV p-p)
ILC6391CP-30
VIN = 3.0V
60
VIN = 1.5V
VIN = 2.0V
40
20
0
VIN = 1.8V
3.0
VIN = 1.0V
2.0
1.5
1.0
0
20
40
60
80
L = 22µH (CD105)
RB = 300
CB = 0
100
OUTPUT CURRENT I OUT (mA)
0.5
0
20
60
100
80
Output Voltage vs. Output Current
ILC6391CP-50
4.0
80
ILC6391CP-30
VIN = 3.0V
3.5
VIN = 2.0V
60
VIN = 1.2V
VIN = 1.5V
40
20
L = 22µH (CD54)
R B = 300
CB = 0
0
0
20
40
60
80
100
OUTPUT VOLTAGE: VOUT(V)
EFFICIENCY: EFFI (%)
40
OUTPUT CURRENT I OUT (mA)
Efficiency vs. Output Current
100
VIN = 1.5V
VIN = 1.2V
2.5
OUTPUT CURRENT I OUT (mA)
VIN = 1.8V
2.5
VIN = 1.2V
VIN = 1.0V
VIN = 1.5V
2.0
1.5
1.0
L = 22µH (CD105)
RB = 300
CB = 0.1µF
0.5
Efficiency vs. Output Current
100
3.0
0
20
40
60
80
100
OUTPUT CURRENT I OUT (mA)
ILC6391CP-30
Ripple Voltage vs. Output Current
VIN = 1.8V
60
500
VIN = 1.5V
VIN = 1.2V
ILC6391CP-30
L = 22µH (CD105)
R B = 300
CB = 0
VIN = 1.0V
400
40
20
L = 22µH (CD105)
R B = 300
C B = 0.1µF
0
0
100
200
300
OUTPUT CURRENT I OUT (mA)
400
500
RIPPLE Vr (mV p-p)
EFFICIENCY: EFFI (%)
80
300
VIN = 1.8V
200
VIN = 1.5V
100
VIN = 1.2V
0
0
100
200
300
400
500
OUTPUT CURRENT I OUT (mA)
©2001 Fairchild Semiconductor Corporation
8
ILC6390/91
Typical Performance Characteristics General conditions for all curves
Ripple Voltage vs. Output Current
Efficiency vs. Output Current
ILC6391CP-50
500
ILC6391CP-50
L = 22µH (CD54)
R B = 500
CB = 0
100
400
VIN = 3.0V
RIPPLE Vr (mV p-p)
EFFICIENCY: EFFI (%)
120
80
VIN = 2.0V
VIN = 1.5V
60
40
20
0
VIN = 3.0V
200
VIN = 2.0V
100
L = 22µH (CD105)
RB = 300
CB = 0.1µF
0
300
150
300
450
600
VIN = 1.5V
0
750
0
100
OUTPUT CURRENT I OUT (mA)
200
300
400
500
OUTPUT CURRENT I OUT (mA)
Output Voltage vs. Output Current
Ripple Voltage vs. Output Current
7.0
ILC6391CP-50
500
ILC6391CP-30
L = 22µH (CD105)
R B = 300
C B = 0.1µF
VIN = 3.0V
5.0
4.0
400
RIPPLE Vr (mV p-p)
OUTPUT VOLTAGE: VOUT(V)
6.0
VIN = 2.0V
VIN = 1.5V
3.0
VIN = 1.2V
2.0
VIN = 1.8V
300
200
VIN = 1.5V
100
1.0
L = 22µH (CD54)
RB = 300
CB = 0.1µF
0
0
100
VIN = 1.2V
0
0
200
300
400
150
500
OUTPUT CURRENT I OUT (mA)
Output Voltage vs. Output Current
450
600
750
Ripple Voltage vs. Output Current
ILC6391CP-50
600
5
ILC6391CP-50
500
VIN = 3.0V
4
VIN = 2.0V
3
VIN = 1.5V
2
1
L = 22µH (CD105)
RB = 300
CB = 0.1µF
0
0
150
RIPPLE Vr (mV p-p)
OUTPUT VOLTAGE VOUT (V)
6
300
OUTPUT CURRENT I OUT (mA)
VIN = 3.0V
400
VIN = 2.0V
VIN = 1.5V
300
200
L = 22µH (CD105)
RB = 300
CB = 0.1µF
100
300
450
OUTPUT CURRENT I OUT (mA)
600
750
0
0
150
300
450
600
750
OUTPUT CURRENT I OUT (mA)
©2001 Fairchild Semiconductor Corporation
9
ILC6390/91
DISCLAIMER
FAIRCHILD SEMICONDUCTOR RESERVES THE RIGHT TO MAKE CHANGES WITHOUT FURTHER NOTICE TO
ANY PRODUCTS HEREIN TO IMPROVE RELIABILITY, FUNCTION OR DESIGN. FAIRCHILD DOES NOT ASSUME
ANY LIABILITY ARISING OUT OF THE APPLICATION OR USE OF ANY PRODUCT OR CIRCUIT DESCRIBED HEREIN;
NEITHER DOES IT CONVEY ANY LICENSE UNDER ITS PATENT RIGHTS, NOR THE RIGHTS OF OTHERS.
LIFE SUPPORT POLICY
FAIRCHILD’S PRODUCTS ARE NOT AUTHORIZED FOR USE AS CRITICAL COMPONENTS IN LIFE SUPPORT DEVICES
OR SYSTEMS WITHOUT THE EXPRESS WRITTEN APPROVAL OF THE PRESIDENT OF FAIRCHILD SEMICONDUCTOR
CORPORATION. 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, and (c) whose failure to
perform when properly used in accordance with
instructions for use provided in the labeling, can be
reasonably expected to result in a significant injury of the
user.
2. A critical component in 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.
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