XICOR X25F128P

APPLICATION NOTE
A V A I L A B L E
AN61 • AN75 • AN77 • AN79 • AN82
X25F128
X25F128
16K x 8 Bits
SerialFlash™ Memory With Block Lock™ Protection
FEATURES
DESCRIPTION
• 1MHz Clock Rate
• SPI Serial Interface
• 16K X 8 Bits
— 32 Byte Small Sector Program Mode
• Low Power CMOS
— <1µA Standby Current
— <5mA Active Current
• 1.8V – 3.6V or 5V “Univolt” Read and
Program Power Supply Versions
• Block Lock Protection
— Protect 1/4, 1/2 or all of E2PROM Array
• Built-in Inadvertent Program Protection
— Power-Up/Power-Down protection circuitry
— Program Enable Latch
— Program Protect Pin
• Self-Timed Program Cycle
— 5ms Program Cycle Time (Maximum)
• High Reliability
— Endurance: 100,000 cycles per byte
— Data Retention: 100 Years
— ESD protection: 2000V on all pins
• 8-Lead PDlP Package
• 16-Lead 150 mil SOIC Package
The X25F128 is a 131,072-bit CMOS SerialFlash
memory, internally organized 16K X 8. It features a
“Univolt” Program and Read voltage, Serial Peripheral
Interface (SPI), and software protocol allowing operation
on a simple three-wire bus. The bus signals are a clock
input (SCK), plus separate data in (SI) and data out (SO)
lines. Access to the device is controlled through a chip
select (CS) input, allowing any number of devices to
share the same bus.
The X25F128 also features two additional inputs that
provide the end user with added flexibility. By asserting
the HOLD input, the X25F128 will ignore transitions on
its inputs, thus allowing the host to service higher priority
interrupts. The PP input can be used as a hardwire input
to the X25F128 disabling all program attempts to the
status register, thus providing a mechanism for limiting
end user capability of altering 0, 1/4, 1/2, or all of the
memory.
The X25F128 utilizes Xicor’s proprietary flash cell, providing a minimum endurance of 100,000 cycles and a
minimum data retention of 100 years.
FUNCTIONAL DIAGRAM
DATA REGISTER
SI
SECTOR DECODE LOGIC
SO
SCK
32
COMMAND
DECODE
AND CONTROL
LOGIC
X
DECODE
LOGIC
8
MEMORY
ARRAY
CS
STATUS
REGISTER
HOLD
PP
HIGH VOLTAGE
CONTROL
PROGRAMMING
CONTROL LOGIC
6829 ILL F01.1
SerialFlash™ and Block Lock™ Protection are trademarks of Xicor, Inc.
© Xicor, Inc. 1995, 1996 Patents Pending
6829-1.9 4/7/97 T3/C0/D0 SH
1
Characteristics subject to change without notice
X25F128
PIN DESCRIPTIONS
Hold (HOLD)
Serial Output (SO)
HOLD is used in conjunction with the CS pin to select the
device. Once the part is selected and a serial sequence
is underway, HOLD may be used to pause the serial
communication with the controller without resetting the
serial sequence. To pause, HOLD must be brought
LOW while SCK is LOW. To resume communication,
HOLD is brought HIGH, again while SCK is LOW. If the
pause feature is not used, HOLD should be held HIGH
at all times.
SO is a push-pull serial data output pin. During a read
cycle, data is shifted out on this pin. Data is clocked out
by the falling edge of the serial clock.
Serial Input (SI)
SI is the serial data input pin. All opcodes, byte
addresses, and data to be written to the memory are
input on this pin. Data is latched by the rising edge of the
serial clock.
PIN CONFIGURATION
Serial Clock (SCK)
The Serial Clock controls the serial bus timing for data
input and output. Opcodes, addresses, or data present
on the SI pin are latched on the rising edge of the clock
input, while data on the SO pin change after the falling
edge of the clock input.
8-LEAD DIP
Chip Select (CS)
CS
1
SO
2
PP
3
VSS
4
When CS is HIGH, the X25F128 is deselected and the
SO output pin is at high impedance and unless an
internal program operation is underway the X25F128
will be in the standby power mode. CS LOW enables
the X25F128, placing it in the active power mode. It
should be noted that after power-up, a HIGH to LOW
transition on CS is required prior to the start of any
operation.
X25F128
8
VCC
7
HOLD
6
SCK
5
SI
16-LEAD SOIC
CS
1
16
SO
2
15
VCC
HOLD
NC
3
14
NC
NC
4
13
NC
NC
5
12
NC
NC
6
11
NC
PP
7
10
SCK
VSS
8
9
Program Protect (PP)
When PP is LOW and the nonvolatile bit PPEN is “1”,
nonvolatile programming of the X25F128 status register
is disabled, but the part otherwise functions normally.
When PP is held HIGH, all functions, including nonvolatile programming operate normally. PP going LOW while
CS is still LOW will interrupt programming of the
X25F128 status register. If the internal program cycle
has already been initiated, PP going LOW will have no
effect on programming.
X25F128
SI
6829 ILL F02.1
PIN NAMES
The PP pin function is blocked when the PPEN bit in
the status register is “0”. This allows the user to install the
X25F128 into a system with PP pin grounded and still
be able to program the status register. The PP pin
functions will be enabled when the PPEN bit is set “0”.
SYMBOL
DESCRIPTION
CS
SO
SI
SCK
PP
VSS
VCC
HOLD
NC
Chip Select Input
Serial Output
Serial Input
Serial Clock Input
Program Protect Input
Ground
Supply Voltage
Hold Input
No Connect
6829 PGM T01
2
X25F128
PRINCIPLES OF OPERATION
formatted as follows:
The X25F128 is a SerialFlash Memory designed
to interface directly with the synchronous serial peripheral interface (SPI) of many popular microcontroller
families.
7
PPEN
6
X
5
X
4
X
3
BL1
2
BL0
1
PEL
0
PIP
6829 PGM T02
PPEN, BL0, and BL1 are set by the PRSR instruction.
PEL and PIP are “read-only” and automatically set by
other operations.
The X25F128 contains an 8-bit instruction register. It is
accessed via the SI input, with data being clocked in on
the rising SCK. CS must be LOW and the HOLD and PP
inputs must be HIGH during the entire operation. The PP
input is “Don’t Care” if PPEN is set “0”.
The Programming-In-Process (PIP) bit indicates
whether the X25F128 is busy with a program operation.
When set to a “1” programming is in progress, when
set to a “0” no programming is in progress. During
programming, all other bits are set to “1”.
Table 1 contains a list of the instructions and their
operation codes. All instructions, addresses and data
are transferred MSB first.
The Program Enable Latch (PEL) bit indicates the
status of the program enable latch. When set to a “1” the
latch is set; when set to a “0” the latch is reset.
Data input is sampled on the first rising edge of SCK after
CS goes LOW. SCK is static, allowing the user to stop
the clock and then resume operations. If the clock line is
shared with other peripheral devices on the SPI bus, the
user can assert the HOLD input to place the X25F128
into a “PAUSE” condition. After releasing HOLD, the
X25F128 will resume operation from the point when
HOLD was first asserted.
The Block Lock (BL0 and BL1) bits are nonvolatile and
allow the user to select one of four levels of protection.
The X25F128 array is divided into four equal segments.
One, two, or all four of the segments may be locked. That
is, the user may read the segments, but will be unable to
alter (program) data within the selected segments. The
partitioning is controlled as illustrated below.
Program Enable Latch
The X25F128 contains a program enable latch. This
latch must be SET before a program operation will be
completed internally. The PREN instruction will set the
latch and the PRDI instruction will reset the latch. This
latch is automatically reset on power-up and after the
completion of a sector program or status register write
cycle.
Status Register Bits
BL1
BL0
0
0
1
1
0
1
0
1
Array Addresses
Locked
None
upper fourth
upper half
All
6829 PGM T03.1
Status Register
Program-Protect Enable
The RDSR instruction provides access to the status
register. The status register may be read at any time,
even during a program cycle. The status register is
The Program-Protect-Enable bit (PPEN) in the
X25F128 status register acts as an enable bit for the
PP pin.
Table 1. Instruction Set
Instruction Name
PREN
PRDI
RDSR
PRSR
READ
Instruction Format*
0000 0110
0000 0100
0000 0101
0000 0001
0000 0011
PROGRAM
0000 0010
Operation
Set the Program Enable Latch (Enable Program Operations)
Reset the Program Enable Latch (Disable Program Operations)
Read Status Register
Program Status Register
Read from Memory Array beginning at Selected Address
Program Memory Array beginning at Selected Address
(32 Bytes)
6829 PGM T04.1
*Instructions are shown MSB in leftmost position. Instructions are transferred MSB first.
3
X25F128
PPEN PP
0
0
1
1
X
X
X
X
LOW
LOW
HIGH
HIGH
Locked
PEL Blocks
0
1
0
1
0
1
Unlocked
Blocks
tion. After the read status register opcode is sent, the
contents of the status register are shifted out on the SO
line. The Read Status Register Sequence is illustrated
in Figure 2.
Status
Register
Locked
Locked
Locked
Locked Programmable Programmable
Locked
Locked
Locked
Locked Programmable
Locked
Locked
Locked
Locked
Locked Programmable Programmable
Programming Sequence
Prior to any attempt to program the X25F128, the
program enable latch must first be set by issuing the
PREN instruction (See Figure 3). CS is first taken LOW,
then the PREN instruction is clocked into the X25F128.
After all eight bits of the instruction are transmitted, CS
must then be taken HIGH. If the user continues the
programming operation without taking CS HIGH after
issuing the PREN instruction, the programming operation will be ignored.
6829 PGM T05
The Program Protect (PP) pin and the nonvolatile
Program Protect Enable (PPEN) bit in the Status Register control the programmable hardware write protect
feature. Hardware program protection is enabled when
PP pin is LOW, and the PPEN bit is “1”. Hardware
program protection is disabled when either the PP pin is
HIGH or the PPEN bit is “0”. When the chip is hardware
program protected, nonvolatile programming of the Status Register in disabled, including the Block Lock bits
and the PPEN bit itself, as well as the Block Lock
sections in the memory array. Only the sections of the
memory array that are not Block Locked can be programmed.
Note:
To program the SerialFlash memory array, the user
issues the PROGRAM instruction, followed by the address of the first location in the sector and then the data
to be programmed. The data is programmed in a 256clock operation. CS must go LOW and remain LOW for
the duration of the operation. The 32 bytes must reside
in the same sector and cannot cross sector boundaries.
If the address counter reaches the end of the sector
and the clock continues, or if fewer than 32 bytes are
clocked in, the contents of the sector cannot be guaranteed.
Since the PPEN bit is program protected, it
cannot be changed back to a “0”, as long as
the PP pin is held LOW.
For the program operation to be completed, CS can only
be brought HIGH after bit 0 of data byte 32 is clocked in.
If it is brought HIGH at any other time, the program
operation will not be completed. Refer to Figure 4 below
for a detailed illustration of the programming sequence
and time frames in which CS going HIGH is valid.
Clock and Data Timing
Data input on the SI line is latched on the rising edge of
SCK. Data is output on the SO line by the falling edge of
SCK.
Read Sequence
To program the status register, the PRSR instruction is
followed by the data to be programmed. Data bits 0, 1,
4, 5 and 6 must be “0”. This sequence is shown in Figure 5.
When reading from the SerialFlash memory array, CS is
first pulled LOW to select the device. The 8-bit READ
instruction is transmitted to the X25F128, followed by
the 16-bit address. After the read opcode and address
are sent, the data stored in the memory at the selected
address is shifted out on the SO line. The data stored in
memory at the next address can be read sequentially by
continuing to provide clock pulses. The address is
automatically incremented to the next higher address
after each byte of data is shifted out. When the highest
address is reached the address counter rolls over to
address $0000, allowing the read cycle to be continued
indefinitely. The read operation is terminated by taking
CS HIGH. Refer to the Read SerialFlash Memory Array
Operation Sequence illustrated in Figure 1.
While the program cycle is in progress, following a
status register or memory write sequence, the status
register may be read to check the PIP bit. During this
time the PIP bit will be HIGH.
Hold Operation
The HOLD input should be HIGH (at VIH) under normal
operation. If a data transfer is to be interrupted HOLD
can be pulled LOW to suspend the transfer until it can
be resumed. The only restriction is that the SCK input
must be LOW when HOLD is first pulled LOW and SCK
must also be LOW when HOLD is released.
The HOLD input may be tied HIGH either directly to VCC
or tied to VCC through a resistor.
To read the status register, the CS line is first pulled
LOW to select the device followed by the 8-bit instruc-
4
X25F128
Operational Notes
Data Protection
The device powers-up in the following state:
The following circuitry has been included to prevent
inadvertent programming:
• The device is in the low power standby state.
• The program enable latch is reset upon power-up.
• A HIGH to LOW transition on CS is required to
enter an active state and receive an instruction.
• A program enable instruction must be issued to set
the program enable latch.
• SO pin is high impedance.
• CS must come HIGH at the proper clock count in
order to start a program cycle.
• The program enable latch is reset.
Figure 1. Read SerialFlash Memory Array Operation Sequence
CS
0
1
2
3
4
5
6
7
8
9
10
20 21 22 23 24 25 26 27 28 29 30
SCK
INSTRUCTION
16 BIT ADDRESS
15 14 13
SI
3
2
1
0
DATA OUT
HIGH IMPEDANCE
7
SO
6
5
4
MSB
CS
1
2
3
4
5
6
7
8
9
10 11 12 13 14
7
6
5
SCK
INSTRUCTION
SI
DATA OUT
HIGH IMPEDANCE
SO
MSB
5
4
3
2
2
1
0
6829 ILL F03
Figure 2. Read Status Register Operation Sequence
0
3
1
0
6829 ILL F04
X25F128
Figure 3. Program Enable Latch Sequence
CS
0
1
2
3
4
5
6
7
SCK
INSTRUCTION
SI
SO
HIGH IMPEDANCE
6829 ILL F05.1
6
X25F128
Figure 4. Programming Sequence
CS
0
1
2
3
4
5
6
7
8
9
20 21 22 23 24 25 26 27 28 29 30 31
10
SCK
INSTRUCTION
DATA BYTE 1
16 BIT ADDRESS
15 14 13
SI
3
2
1
7
0
6
5
4
3
2
1
CS
32 33 34 35 36 37 38 39 40 41 42 43 44 45 46 47
SCK
DATA BYTE 2
SI
7
6
5
4
3
DATA BYTE 3
2
1
0
7
6
5
4
3
DATA BYTE 32
2
1
0
6
5
4
3
2
1
0
6829 ILL F07
Figure 5. Program Status Register Operation Sequence
CS
0
1
2
3
4
5
6
7
8
9
10 11 12 13 14 15
SCK
DATA BYTE
INSTRUCTION
7
SI
6
5
4
3
2
1
0
HIGH IMPEDANCE
SO
6829 ILL F08
7
0
X25F128
ABSOLUTE MAXIMUM RATINGS*
Temperature Under Bias .................. –65°C to +135°C
Storage Temperature ....................... –65°C to +150°C
Voltage on any Pin with Respect to VSS ......... –1V to +7V
D.C. Output Current ............................................. 5mA
Lead Temperature
(Soldering, 10 Seconds) ............................. 300°C
*COMMENT
Stresses above those listed under “Absolute Maximum
Ratings” may cause permanent damage to the device.
This is a stress rating only and the functional operation
of the device at these or any other conditions above
those listed in the operational sections of this specification
is not implied. Exposure to absolute maximum rating
conditions for extended periods may affect device reliability.
RECOMMENDED OPERATING CONDITIONS
Temp
Commercial
Extended
Industrial
Min.
0°C
–20°C
–40°C
Supply Voltage
X25F128
X25F128–5
Max.
+70°C
+85°C
+85°C
Limits
1.8V to 3.6V
4.5V to 5.5V
6829 PGM T07.1
6829 PGM T06.1
D.C. OPERATING CHARACTERISTICS (Over the recommended operating conditions unless otherwise specified.)
Limits
Symbol
Parameter
Min.
Max.
Units
5
mA
ICC
VCC Supply Current (Active)
ISB1(2)
ISB2
ILI
ILO
VIL(1)
VIH(1)
VOL1
VOH1
VOL2
VOH2
VCC Supply Current (Standby)
1
VCC Supply Current (Standby)
10
Input Leakage Current
10
Output Leakage Current
10
Input LOW Voltage
–0.5
VCC x 0.3
Input HIGH Voltage
VCC x 0.7 VCC + 0.5
Output LOW Voltage
0.4
Output HIGH Voltage
VCC – 0.3
Output LOW Voltage
0.4
Output HIGH Voltage
VCC – 0.8
µA
µA
µA
µA
V
V
V
V
V
V
Test Conditions
SCK = VCC x 0.1/VCC x 0.9 @ 1MHz,
SO = OPEN, CS = VSS
CS = VCC, VIN = VSS or VCC, VCC = 3.6V
CS = VCC, VIN = VSS or VCC, VCC = 5V
VIN = VSS to VCC
VOUT = VSS to VCC
IOL = 1.5mA, VCC = 2.7V
IOH = –0.4mA, VCC = 2.7V
IOL = 3mA, VCC = 5V
IOH = –1.6mA, VCC = 5V
6829 PGM T08.1
POWER-UP TIMING
Symbol
tPUR(3)
Parameter
Power-up to Read Operation
tPUW(3)
Power-up to Write Operation
Min.
Max.
1
Units
ms
5
ms
6829 PGM T09
CAPACITANCE TA = 25°C, f = 1MHz, VCC = 5V.
Symbol
COUT(2)
CIN(2)
Notes:
Test
Output Capacitance (SO)
Input Capacitance (SCK, SI, CS, PP, HOLD)
Max.
8
6
Units
pF
pF
Conditions
VOUT = 0V
VIN = 0V
6829 PGM T10
(1) VIL min. and VIH max. are for reference only and are not tested.
(2) This parameter is periodically sampled and not 100% tested.
(3) tPUR and tPUW are the delays required from the time VCC is stable until the specified operation can be initiated. These parameters
are periodically sampled and not 100% tested.
8
X25F128
EQUIVALENT A.C. LOAD CIRCUIT
2.7V
Input Pulse Levels
VCC x 0.1 to VCC x 0.9
Input Rise and Fall Times
10ns
Input and Output Timing Level
VCC x 0.5
5V
1.64KΩ
1.44KΩ
OUTPUT
4.63KΩ
A.C. TEST CONDITIONS
6829 PGM T11
OUTPUT
100pF
1.95KΩ
100pF
6829 ILL F09.1
A.C. CHARACTERISTICS (Over recommended operating conditions, unless otherwise specified)
Data Input Timing
Symbol
fSCK
tCYC
tLEAD
tLAG
tWH
tWL
tSU
tH
tRI(4)
tFI(4)
tHD
tCD
tCS
tPC(5)
Parameter
Clock Frequency
Cycle Time
CS Lead Time
CS Lag Time
Clock HIGH Time
Clock LOW Time
Data Setup Time
Data Hold Time
Data In Rise Time
Data In Fall Time
HOLD Setup Time
HOLD Hold Time
CS Deselect Time
Program Cycle Time
Min.
0
1000
500
500
400
400
100
100
Max.
1
2
2
200
200
2
10
Units
MHz
ns
ns
ns
ns
ns
ns
ns
µs
µs
ns
ns
µs
ms
6829 PGM T12.1
Data Output Timing
Symbol
fSCK
tDIS
tV
tHO
tRO(4)
tFO(4)
tLZ(4)
tHZ(4)
Parameter
Clock Frequency
Output Disable Time
Output Valid from Clock LOW
Output Hold Time
Output Rise Time
Output Fall Time
HOLD HIGH to Output in Low Z
HOLD LOW to Output in High Z
Min.
Max.
Units
0
1
500
400
MHz
ns
ns
ns
ns
ns
ns
ns
0
300
300
100
100
6829 PGM T13
Notes: (4) This parameter is periodically sampled and not 100% tested.
(5) tWC is the time from the rising edge of CS after a valid write sequence has been sent to the end of the self-timed internal
nonvolatile program cycle.
9
X25F128
Serial Output Timing
CS
tCYC
tWH
tLAG
SCK
tV
SO
SI
tHO
MSB OUT
tWL
tDIS
MSB–1 OUT
LSB OUT
ADDR
LSB IN
6829 ILL F10
Serial Input Timing
tCS
CS
tLEAD
tLAG
SCK
tSU
SI
tH
tRI
MSB IN
tFI
LSB IN
HIGH IMPEDANCE
SO
6829 ILL F11
10
X25F128
Hold Timing
CS
tHD
tCD
tCD
tHD
SCK
tHZ
tLZ
SO
SI
HOLD
6829 ILL F12
11
X25F128
PACKAGING INFORMATION
8-LEAD PLASTIC DUAL IN-LINE PACKAGE TYPE P
0.430 (10.92)
0.360 (9.14)
0.260 (6.60)
0.240 (6.10)
PIN 1 INDEX
PIN 1
0.300
(7.62) REF.
HALF SHOULDER WIDTH ON
ALL END PINS OPTIONAL
0.145 (3.68)
0.128 (3.25)
SEATING
PLANE
0.025 (0.64)
0.015 (0.38)
0.065 (1.65)
0.045 (1.14)
0.150 (3.81)
0.125 (3.18)
0.020 (0.51)
0.016 (0.41)
0.110 (2.79)
0.090 (2.29)
0.015 (0.38)
MAX.
0.060 (1.52)
0.020 (0.51)
0.325 (8.25)
0.300 (7.62)
0°
15°
TYP. 0.010 (0.25)
NOTE:
1. ALL DIMENSIONS IN INCHES (IN PARENTHESES IN MILLIMETERS)
2. PACKAGE DIMENSIONS EXCLUDE MOLDING FLASH
3926 FHD F01
12
X25F128
PACKAGING INFORMATION
16-LEAD PLASTIC SMALL OUTLINE GULL WING PACKAGE TYPE S
0.150 (3.80)
0.158 (4.00)
0.228 (5.80)
0.244 (6.20)
PIN 1 INDEX
PIN 1
0.014 (0.35)
0.020 (0.51)
0.386 (9.80)
0.394 (10.01)
(4X) 7°
0.053 (1.35)
0.069 (1.75)
0.004 (0.19)
0.010 (0.25)
0.050 (1.27)
0.050" Typical
0.010 (0.25)
X 45°
0.020 (0.50)
0.050"
Typical
0° – 8°
0.250"
0.0075 (0.19)
0.012 (0.30)
0.016 (0.410)
0.037 (0.937)
FOOTPRINT
0.030" Typical
16 Places
NOTE: ALL DIMENSIONS IN INCHES (IN PARENTHESES IN MILLIMETERS)
3926 FHD F26
13
X25F128
ORDERING INFORMATION
X25F128
P
T
–X
Device
VCC Range
Blank = 1.8V to 3.6V
5 = 4.5V to 5.5V
Temperature Range
Blank = Commercial = 0°C to +70°C
E = Extended = –20°C to +85°C
I = Industrial = –40°C to +85°C
Package
P = 8-Lead Plastic DIP
S = 16-Lead SOIC
Part Mark Convention
P = 8-Lead Plastic DIP
S = 16-Lead SOIC
X25F128
X
Blank = 1.8V to 3.6V, 0°C to +70°C
5 = 4.5V to 5.5V, 0°C to +70°C
I5 = 4.5V to 5.5V, –40°C to +85°C
LIMITED WARRANTY
Devices sold by Xicor, Inc. are covered by the warranty and patent indemnification provisions appearing in its Terms of Sale only. Xicor, Inc. makes no warranty,
express, statutory, implied, or by description regarding the information set forth herein or regarding the freedom of the described devices from patent infringement.
Xicor, Inc. makes no warranty of merchantability or fitness for any purpose. Xicor, Inc. reserves the right to discontinue production and change specifications and
prices at any time and without notice.
Xicor, Inc. assumes no responsibility for the use of any circuitry other than circuitry embodied in a Xicor, Inc. product. No other circuits, patents, licenses are
implied.
U.S. PATENTS
Xicor products are covered by one or more of the following U.S. Patents: 4,263,664; 4,274,012; 4,300,212; 4,314,265; 4,326,134; 4,393,481; 4,404,475;
4,450,402; 4,486,769; 4,488,060; 4,520,461; 4,533,846; 4,599,706; 4,617,652; 4,668,932; 4,752,912; 4,829, 482; 4,874, 967; 4,883, 976. Foreign patents and
additional patents pending.
LIFE RELATED POLICY
In situations where semiconductor component failure may endanger life, system designers using this product should design the system with appropriate error
detection and correction, redundancy and backup features to prevent such an occurrence.
Xicor's products are not authorized for use in critical components in life support devices or systems.
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 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 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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