FAIRCHILD FAN1585AMC15X

www.fairchildsemi.com
FAN1585A
5A Adjustable/Fixed Low Dropout Linear Regulator
Features
Description
•
•
•
•
•
•
The FAN1585A, FAN1585A-1.5, and FAN1585A-1.8 are
low dropout three-terminal regulators with 5A output current
capability. These devices have been optimized for low voltage applications including VTT bus termination for FC-PGA,
where transient response and minimum input voltage are
critical. The FAN1585A-1.5 offers fixed 1.5V with 5A
current capabilities for AGTL+ bus VTT termination for
FC-PGA. The FAN1585A is ideal for low voltage microprocessor applications requiring a regulated output from
1.5V to 3.6V with an input supply of 5V or less, or for
FC-PGA applications with significant trace resistance.
Fast transient response
Low dropout voltage at up to 5A
Load regulation: 0.05% typical
Trimmed current limit
On-chip thermal limiting
Packages: TO-220, TO-252, TO-263 and TO-263 Centercut
Applications
•
•
•
•
•
AGTL+ bus supply for FC-PGA
Low voltage logic supply
Post regulator for switching supply
3.3V to 1.5V linear regulator
5V to 1.8V linear regulator
Current limit is trimmed to ensure specified output current
and controlled short-circuit current. On-chip thermal limiting provides protection against any combination of overload
and ambient temperature that would create excessive junction temperatures.
The FAN1585A series regulators are available in the industrystandard TO-220, TO-252, TO-263 and TO-263 Centercut
power packages.
Typical Applications
FAN1585A
VOUT
VIN
VIN = 3.3V
22µF
+
ADJ
1.5V at 5A
+
R1
124Ω
22µF
R2
24.9Ω
VOUT = VREF(1 + R2/R1) + IAdj • R2
FAN1585A-1.5
VIN
VOUT
VIN = 3.3V
+
22µF
GND
1.5V at 5A
+
22µF
REV. 1.1.6 7/8/05
FAN1585A
PRODUCT SPECIFICATION
Pin Assignments
FRONT VIEW
1
2
FRONT VIEW
FRONT VIEW
FRONT VIEW
Tab is VOUT
Tab is Out.
3
Tab is Out.
1
1
ADJ/ OUT IN
GND
2
ADJ/ OUT
GND
3-Lead Plastic TO-220
θJC = 3°C/W
2
Tab is Out.
1
3
2
3
3
ADJ/
GND
ADJ/ OUT IN
GND
IN
3-Lead Plastic TO-252
θJC = 3°C/W
IN
3-Lead Plastic TO-263 Center Cut
θJC = 3°C/W*
3-Lead Plastic TO-263
θJC = 3°C/W*
*With package soldered to 0.5 square inch copper area over backside ground plane or internal power plane, θJA can vary from
30°C/W to more than 40°C/W. Other mounting techniques can provide a thermal resistance lower than 30°C/W.
Absolute Maximum Ratings
Parameter
Min.
Max.
Unit
18
V
0
125
°C
-65
150
°C
300
°C
VIN
Operating Junction Temperature Range
Storage Temperature Range
Lead Temperature (Soldering, 10 sec.)
7
6
IOUT (Amps)
5
4
3
2
1
0
0
2
4
6
8
10
12
14
VIN–VOUT (V)
Absolute Maximum Safe Operating Area
2
REV. 1.1.6 7/8/05
PRODUCT SPECIFICATION
FAN1585A
Electrical Characteristics
Tj = 25°C unless otherwise specified.
The • denotes specifications which apply over the specified operating temperature range.
Parameter
Conditions
3
Min.
Typ.
Max
Units
Reference Voltage
1.5V ≤ (VIN – VOUT) ≤ 5.75V,
10mA ≤ IOUT ≤ 5A
•
1.225
(-2%)
1.250
1.275
(+2%)
V
Output Voltage4
3.0V ≤ VIN ≤ 8V
10mA ≤ IOUT ≤ 5A
•
1.47
1.5
1.53
V
Output Voltage5
3.3V ≤ VIN ≤ 8.3V
10mA ≤ IOUT ≤ 5A
•
1.764
1.8
1.836
V
Line Regulation1, 2
(VOUT + 1.5V) ≤ VIN ≤ 12V,
IOUT = 10mA
•
0.005
0.2
%
Load Regulation1, 2, 3
(VIN – VOUT) = 3V,
10mA ≤ IOUT ≤ 5A
•
0.05
0.5
%
Dropout Voltage
∆VREF = 1%, IOUT = 5A
•
1.150
1.300
Current Limit
(VIN – VOUT) = 2V
•
Adjust Pin Current3
Adjust Pin Current
Change3
5.1
5.9
V
A
•
35
120
µA
1.5V ≤ (VIN – VOUT) ≤ 5.75V,
10mA ≤ IOUT ≤ 5A
•
0.2
5
µA
4
13
Minimum Load Current
1.5V ≤ (VIN – VOUT) ≤ 12V
•
Quiescent Current
VIN = 5V
•
Ripple Rejection
f = 120Hz, COUT = 22µF Tantalum,
(VIN – VOUT) = 3V, IOUT = 5A
Thermal Regulation
TA = 25°C, 30ms pulse
60
mA
72
0.004
•
Temperature Stability
10
mA
dB
0.02
0.5
%/W
%
Long-Term Stability
TA = 125°C, 1000 hrs.
0.03
RMS Output Noise
(% of VOUT)
TA = 25°C, 10Hz ≤ f ≤ 10kHz
0.003
%
Thermal Resistance,
Junction to Case
TO-220, TO-252, TO-263, and
TO-263 CC
3
°C/W
150
°C
Thermal Shutdown
1.0
%
Notes:
1. See thermal regulation specifications for changes in output voltage due to heating effects. Load and line regulation are
measured at a constant junction temperature by low duty cycle pulse testing.
2. Line and load regulation are guaranteed up to the maximum power dissipation. Power dissipation is determined by input/
output differential and the output currrent. Guaranteed maximum output power will not be available over the full input/output
voltage range.
3. FAN1585A only.
4. FAN1585A-1.5 only.
5. FAN1585A-1.8 only.
REV. 1.1.6 7/8/05
3
FAN1585A
PRODUCT SPECIFICATION
Typical Performance Characteristics
1.5
0.10
OUTPUT VOLTAGE DEVIATION (%)
DROPOUT VOLTAGE (V)
1.4
1.3
1.2
1.1
1.0
T=0°C
0.9
T=125°C
T=25°C
0.8
0.7
0.6
0.05
0
-0.05
-0.10
-0.15
-0.20
-75 -50 -25
0.5
0
1
2
3
4
5
6
1.275
3.70
1.270
3.65
1.265
3.60
VOUT set with 1% Resistors
1.260
1.255
1.250
1.245
1.240
1.235
1
VOUT = 3.6V
3.55
3.50
3.45
3.40
3.35
3.30
1.230
1
VOUT = 3.3V
Note:
1. FAN1585A Only
3.25
1.225
-75 -50 -25
0
3.20
-75 -50 -25
25 50 75 100 125 150 175
JUNCTION TEMPERATURE (°C)
Figure 3. Reference Voltage vs. Temperature
0
25 50 75 100 125 150 175
JUNCTION TEMPERATURE (°C)
Figure 4. Output Voltage vs. Temperature
5
100
Note:
1. FAN1585A Only
90
ADJUST PIN CURRENT (µA)
MINIMUM LOAD CURRENT (mA)
25 50 75 100 125 150 175
Figure 2. Load Regulation vs. Temperature
REFERENCE VOLTAGE (V)
REFERENCE VOLTAGE (V)
0
JUNCTION TEMPERATURE (°C)
OUTPUT CURRENT (A)
Figure 1. Dropout Voltage vs. Output Current
∆I = 5A
4
3
2
1
80
70
60
50
40
30
20
10
0
-75 -50 -25
0
25 50 75 100 125 150 175
JUNCTION TEMPERATURE (°C)
Figure 5. Minimum Load Current vs. Temperature
4
0
-75 -50 -25
0
25 50 75 100 125 150 175
JUNCTION TEMPERATURE (°C)
Figure 6. Adjust Pin Current vs. Temperature
REV. 1.1.6 7/8/05
PRODUCT SPECIFICATION
FAN1585A
Typical Performance Characteristics (continued)
90
8.0
RIPPLE REJECTIONS (dB)
SHORT-CIRCUIT CURRENT (A)
80
7.0
6.0
5.0
70
60
50
40
30
(VIN – VOUT) ≤ 3V
0.5V ≤ VRIPPLE ≤ 2V
IOUT = 5A
20
10
4.0
-75 -50 -25
0
0
10
25 50 75 100 125 150 175
100
Figure 7. Short-Circuit Current vs. Temperature
100K
2.5
OUTPUT CAPACITANCE ESR, (Ω)
POWER (W)
10K
Figure 8. Ripple Rejection vs. Frequency
20
15
10
5
0
50 60 70 80 90 100 110 120 130 140 150
CASE TEMPERATURE (°C)
Figure 9. Maximum Power Dissipation
REV. 1.1.6 7/8/05
1K
FREQUENCY (Hz)
JUNCTION TEMPERATURE (°C)
2
1.5
Area of Instability
1
0.5
Stable Area
0
0
1000
2000
3000
4000
5000
LOAD CURRENT (mA)
Figure 10. Stability Region VIN/VOUT = 5V/1.5V
5
FAN1585A
PRODUCT SPECIFICATION
Applications Information
General
The FAN1585A and FAN1585A-1.5 are three-terminal regulators optimized for GTL+ VTT termination and logic applications. These devices are short-circuit protected and offer
thermal shutdown to turn off the regulator when the junction
temperature exceeds about 150°C. The FAN1585A series
provides low dropout voltage and fast transient response.
Frequency compensation uses capacitors with low ESR
while still maintaining stability. This is critical in addressing
the needs of low voltage high speed microprocessor buses
like GTL+.
break down and none of the protection circuitry is then functional.
D1
1N4002
(OPTIONAL)
FAN1585A
VIN
Stability
The FAN1585A series requires an output capacitor as a part
of the frequency compensation. It is recommended to use a
22µF solid tantalum or a 100 µF aluminum electrolytic on
the output to ensure stability. The frequency compensation of
these devices optimizes the frequency response with low
ESR capacitors. In general, it is suggested to use capacitors
with an ESR of <300mΩ. It is also recommended to use
bypass capacitors such as a 22µF tantalum or a 100µF aluminum on the adjust pin of the FAN1585A for low ripple and
fast transient response. When these bypassing capacitors are
not used at the adjust pin, larger values of output capacitors
provide equally good results. Refer to Typical Performance
Characteristics for graph of stability of output capacitance
ESR vs load current.
+
C1
22µF
IN
OUT
ADJ
+
R1
VOUT
C2
22µF
+
CADJ
R2
D1
1N4002
(OPTIONAL)
FAN1585A-1.5
VIN
C1
22µF
IN
+
OUT
GND
+
VOUT
C2
22µF
Figure 10. Optional Protection
Protection Diodes
Ripple Rejection
In normal operation, the FAN1585A series does not require
any protection diodes. For the FAN1585A, internal resistors
limit internal current paths on the adjust pin. Therefore, even
with bypass capacitors on the adjust pin, no protection diode
is needed to ensure device safety under short-circuit conditions.
In applications that require improved ripple rejection, a
bypass capacitor from the adjust pin of the FAN1585A to
ground reduces the output ripple by the ratio of VOUT/1.25V.
The impedance of the adjust pin capacitor at the ripple
frequency should be less than the value of R1 (typically in
the range of 100Ω to 120Ω) in the feedback divider network
in Figure 10. Therefore, the value of the required adjust pin
capacitor is a function of the input ripple frequency. For
example, if R1 equals 100Ω and the ripple frequency equals
120Hz, the adjust pin capacitor should be 22µF. At 10kHz,
only 0.22µF is needed.
A protection diode between the input and output pins is
usually not needed. An internal diode between the input and
the output pins on the FAN1585A series can handle microsecond surge currents of 50A to 100A. Even with large value
output capacitors it is difficult to obtain those values of surge
currents in normal operation. Only with large values of output
capacitance, such as 1000µF to 5000µF, and with the input
pin instantaneously shorted to ground can damage occur. A
crowbar circuit at the input can generate those levels of current; a diode from output to input is then recommended, as
shown in Figure 10. Usually, normal power supply cycling
or system “hot plugging and unplugging” will not generate
current large enough to do any damage.
The adjust pin can be driven on a transient basis ±7V with
respect to the output, without any device degradation. As
with any IC regulator, exceeding the maximum input-tooutput voltage differential causes the internal transistors to
6
Output Voltage
The FAN1585A regulator develops a 1.25V reference voltage between the output pin and the adjust pin (see Figure
11). Placing a resistor R1 between these two terminals
causes a constant current to flow through R1 and down
through R2 to set the overall output voltage. Normally, this
current is the specified minimum load current of 10mA.
The current out of the adjust pin adds to the current from R1
and is typically 35µA. Its output voltage contribution is
small and only needs consideration when a very precise output voltage setting is required.
REV. 1.1.6 7/8/05
PRODUCT SPECIFICATION
FAN1585A
FAN1585A
VIN
IN
+
OUT
C1
22µF
ADJ
+
VREF
IADJ
35µA
R1
FAN1585A
VOUT
VIN
C2
22µF
IN
RP
PARASITIC
LINE RESISTANCE
OUT
ADJ
R1*
R2
RL
VOUT = VREF (1 + R2/R1) + IADJ (R2)
* CONNECT R1 TO CASE
CONNECT R2 TO LOAD
Figure 11. Basic Regulator Circuit
R2*
Load Regulation
It is not possible to provide true remote load sensing because
the FAN1585A series are three-terminal devices. Load regulation is limited by the resistance of the wire connecting the
regulators to the load. Load regulation per the data sheet
specification is measured at the bottom of the package.
For fixed voltage devices, negative side sensing is a true
Kelvin connection with the ground pin of the device returned
to the negative side of the load. This is illustrated in Figure 12.
FAN1585A-1.5
VIN
IN
RP
PARASITIC
LINE RESISTANCE
OUT
Figure 13. Connection for Best Load Regulation
Thermal Considerations
The FAN1585A series protect themselves under overload
conditions with internal power and thermal limiting circuitry.
However, for normal continuous load conditions, do not
exceed maximum junction temperature ratings. It is important to consider all sources of thermal resistance from junction-to-ambient. These sources include the junction-to-case
resistance, the case-to-heat sink interface resistance, and the
heat sink resistance. Thermal resistance specifications have
been developed to more accurately reflect device temperature and ensure safe operating temperatures.
GND
RL
For example, look at using an FAN1585AT to generate 5A
@ 1.5V ± 2% from a 3.3V source (3.2V to 3.6V).
Assumptions:
Figure 12. Connection for Best Load Regulation
For adjustable voltage devices, negative side sensing is a true
Kelvin connection with the bottom of the output divider
returned to the negative side of the load. The best load regulation is obtained when the top of the resistor divider R1 connects directly to the regulator output and not to the load.
Figure 13 illustrates this point.
If R1 connects to the load, then the effective resistance
between the regulator and the load would be:
RP x (1 + R2/R1), RP = Parasitic Line Resistance
The connection shown in Figure 13 does not multiply RP by
the divider ratio. As an example, RP is about four milliohms
per foot with 16-gauge wire. This translates to 4mV per foot
at 1A load current. At higher load currents, this drop represents a significant percentage of the overall regulation. It is
important to keep the positive lead between the regulator and
the load as short as possible and to use large wire or PC
board traces.
REV. 1.1.6 7/8/05
•
•
•
•
•
VIN = 3.6V worst case
VOUT = 1.46V worst case
IOUT = 5A continuous
TA = 50°C
θCase-to-Ambient = 3°C/W (assuming both a heatsink and
a thermally conductive material)
The power dissipation in this application is:
PD = (VIN – VOUT) * (IOUT) = (3.6 – 1.46) * (5) = 10.7W
From the specification table:
TJ = TA + (PD) * (θCase-to-Ambient + θJC)
= 50 + (10.7) * (3 + 3) = 115°C
The junction temperature is below the maximum rating.
7
FAN1585A
PRODUCT SPECIFICATION
Junction-to-case thermal resistance is specified from the IC
junction to the bottom of the case directly below the die. This
is the lowest resistance path for heat flow. Proper mounting
ensures the best thermal flow from this area of the package to
the heat sink. Use of a thermally conductive material at the
case-to-heat sink interface is recommended. Use a thermally
conductive spacer if the case of the device must be electrically isolated and include its contribution to the total thermal
resistance. The cases of the FAN1585A series are directly
connected to the output of the device.
U1
FAN1585A
VIN
3.3V
C1
22µF
+
VOUT
1.5V
VOUT
VIN
R1
124Ω
ADJ
+
+
C3
100µF
R2
24.9Ω
C2
100µF
Figure 14. Application Circuit (FAN1585A)
Table 1. Bill of Materials for Application Circuit for the FAN1585A
Item
Quantity
Manufacturer
Part Number
C1
1
Xicon
L10V22
22µF, 10V Aluminum
C2, C3
2
Xicon
L10V100
100µF, 10V Aluminum
R1
1
Generic
124Ω, 1%
R2
1
Generic
24.9Ω, 1%
U1
1
Fairchild
FAN1585AT
U1
FAN1585A-1.5
VIN
3.3V
VIN
C1
22µF
Description
+
VOUT
1.5V
VOUT
GND
+
5A Regulator
C3
100µF
Figure 15. Application Circuit (FAN1585A-1.5)
Table 2. Bill of Materials for Application Circuit for the FAN1585A-1.5
Item
Quantity
Manufacturer
Part Number
C1
1
Xicon
L10V22
22µF, 10V Aluminum
C3
1
Xicon
L10V100
100µF, 10V Aluminum
U1
1
Fairchild
FAN1585AT-1.5
8
Description
5A Regulator
REV. 1.1.6 7/8/05
PRODUCT SPECIFICATION
FAN1585A
Mechanical Dimensions
3-Lead TO-263 Package
Symbol
Inches
Millimeters
Notes
Min.
Max.
Min.
Max.
A
b
b2
c2
D
E
e
.160
.020
.190
.036
4.06
0.51
4.83
0.91
L
L1
L2
R
α
.575
.090
—
.017
0°
.049
.051
.045
.055
.340
.380
.380
.405
.100 BSC
.625
.110
.055
.019
8°
1.25
1.30
1.14
1.40
8.64
9.65
9.65
10.29
2.54 BSC
14.61
2.29
—
0.43
0°
Notes:
1. Dimensions are exclusive of mold flash and metal burrs.
2. Standoff-height is measured from lead tip with ref. to Datum -B-.
3. Foot length is measured with ref. to Datum -A- with lead surface
(at inner R).
4. Dimensiuon exclusive of dambar protrusion or intrusion.
5. Formed leads to be planar with respect to one another at seating
place -C-.
15.88
2.79
1.40
0.78
8°
E
@PKG/
@HEATSINK
L2
c2
D
E-PIN
L
R (2 PLCS)
b2
L1
b
e
-B-
-A-
A
-C-
REV. 1.1.6 7/8/05
9
FAN1585A
PRODUCT SPECIFICATION
Mechanical Dimensions (continued)
3-Lead TO-263 Center Cut Package
Symbol
Inches
Millimeters
Notes
Min.
Max.
Min.
Max.
A
b
b2
c2
D
E
e
.160
.020
.190
.036
4.06
0.51
4.83
0.91
L
L1
L2
.575
.090
—
.050
.017
0°
.049
.051
.045
.055
.340
.380
.380
.405
.100 BSC
L3
R
α
.625
.110
.055
.070
.019
8°
1.25
1.30
1.14
1.40
8.64
9.65
9.65
10.29
2.54 BSC
14.61
2.29
—
1.27
0.43
0°
Notes:
1. Dimensions are exclusive of mold flash and metal burrs.
2. Standoff-height is measured from lead tip with ref. to Datum -B-.
3. Foot length is measured with ref. to Datum -A- with lead surface
(at inner R).
4. Dimensiuon exclusive of dambar protrusion or intrusion.
5. Formed leads to be planar with respect to one another at seating
place -C-.
15.88
2.79
1.40
1.78
0.78
8°
E
@PKG/
@HEATSINK
L2
c2
D
E-PIN
L
R (2 PLCS)
b2
L1
L3
b
e
-B-
-A-
A
-C-
10
REV. 1.1.6 7/8/05
PRODUCT SPECIFICATION
FAN1585A
Mechanical Dimensions (continued)
3-Lead TO-220 Package
Inches
Symbol
Min.
A
b
b1
c1
øP
D
E
e
Millimeters
Max.
Min.
.140
.190
.015
.040
.045
.070
.014
.022
.139
.161
.560
.650
.380
.420
.090
.110
.190
.210
.045
—
.020
.055
.230
.270
.060
.115
.500
.580
.250 BSC
.100
.135
3°
7°
e1
e3
F
H1
J1
L
L1
Q
α
Notes
Max.
3.56
4.83
.38
1.02
1.14
1.78
.36
.56
3.53
4.09
14.22
16.51
9.65
10.67
2.29
2.79
4.83
5.33
1.14
—
.51
1.40
5.94
6.87
2.04
2.92
12.70
14.73
6.35 BSC
2.54
3.43
3°
7°
Notes:
1. Dimension c1 apply for lead finish.
H1
Q
L
e3
b1
e
e1
E
b
L1
E-PIN
øP
α (5X)
c1
A
J1
D
REV. 1.1.6 7/8/05
F
11
FAN1585A
PRODUCT SPECIFICATION
Mechanical Dimensions (continued)
3-Lead TO-252 Package
A
6.73
6.35
5.46
5.21
6.00 MIN
L3
4
6.50 MIN
D
6.25
1.02
0.84
C
1
3.00 MIN
2
3
1
1.14
0.78
(0.59)
0.89
0.54
2.30
1.40 MIN
4.80
2.29
4.57
0.25 M A M C
3
LAND PATTERN RECOMMENDATION
B
2.38
2.18
SEE
NOTE D
E1
0.58
0.48
4
D1
10.41
9.40
SEE
DETAIL A
2
3
1
0.10 B
0.61
0.48
(1.54)
10°
0°
1.78
1.40
0.127 MAX
2.90
SEATING PLANE
DETAIL A
(ROTATED –90°
SCALE 12X
12
NOTES: UNLESS OTHERWISE SPECIFIED
A)
ALL DIMENSIONS ARE IN MILLIMETERS.
B)
THIS PACKAGE CONFORMS TO JEDEC, TO-252,
ISSUE C. VARIATION AA & AB, DATED NOV. 1999.
0.51
GAGE PLANE
C)
DIMENSIONING AND TOLERANCING PER
ASME Y14.5–1994.
D)
HEAT SINK TOP EDGE COULD BE IN CHAMFERED
CORNERS OR EDGE PROTRUSION.
E)
DIMENSIONS L3, D, E1 & D1 TABLE:
OPTION AA OPTION AB
L3 0.89 – 1.27 1.52 – 2.03
D
5.97 – 6.22 5.33 – 5.59
E1 4.32 MIN
3.81 MIN
D1 5.21 MIN
4.57 MIN
REV. 1.1.6 7/8/05
FAN1585A
PRODUCT SPECIFICATION
Ordering Information
Product Number
Package
FAN1585AMX
TO-263 in Tape and Reel
FAN1585AMCX
TO-263 Center Cut in Tape and Reel
FAN1585AT
TO-220
FAN1585AM15X
TO-263 in Tape and Reel
FAN1585AMC15X
TO-263 Center Cut in Tape and Reel
FAN1585AT15
TO-220
FAN1585AM18X
TO-263 in Tape and Reel
FAN1585AMC18X
TO-263 Center Cut in Tape and Reel
FAN1585AT18
TO-220
FAN1585AD
TO-252
FAN1585ADX
TO-252 in Tape and Reel
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, or (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 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.
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