X25401S [XICOR]

SPI Serial AUTOSTORE⑩ NOVRAM; 串行SPI ™自动存储NOVRAM
X25401S
型号: X25401S
厂家: XICOR INC.    XICOR INC.
描述:

SPI Serial AUTOSTORE⑩ NOVRAM
串行SPI ™自动存储NOVRAM

存储 内存集成电路 静态存储器 光电二极管
文件: 总14页 (文件大小:60K)
中文:  中文翻译
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APPLICATION NOTE  
A V A I L A B L E  
AN56  
256 Bit  
X25401  
16 x 16 Bit  
SPI Serial AUTOSTORE™ NOVRAM  
FEATURES  
DESCRIPTION  
1MHz Clock Rate  
The Xicor X25401 is a serial 256 bit NOVRAM featuring  
a static RAM configured 16 x 16, overlaid bit-by-bit with  
a nonvolatile E PROM array. The X25401 features a  
AUTOSTORE™ NOVRAM  
2
—Automatically Performs a Store Operation  
Upon Loss of V  
Serial Peripheral Interface (SPI) and software protocol  
allowing operation on a simple three-wire bus. The bus  
signalsareaclockinput(SCK)plusseparatedatain(SI)  
and data out (SO) lines. Access to the device is con-  
trolled through a chip select (CS) input, allowing any  
number of devices to share the same bus.  
CC  
Single 5 Volt Supply  
Ideal for use with Single Chip Microcomputers  
—Minimum I/O Interface  
—SPI Mode (0,0 & 1,1) Serial Port Compatible  
—Easily Interfaced to Microcontroller Ports  
Software and Hardware Control of Nonvolatile  
Functions  
TheXicorNOVRAMdesignallowsdatatobetransferred  
between the two memory arrays by means of software  
commands or external hardware inputs. A store opera-  
Auto Recall on Power-Up  
TTL and CMOS Compatible  
Low Power Dissipation  
2
tion (RAM data to E PROM) is completed in 5ms or less  
2
and a recall operation (E PROM data to RAM) is com-  
—Active Current: 10mA  
pleted in 2µs or less.  
—Standby Current: 50µA  
8-Lead PDIP and 8-Lead SOIC Packages  
The X25401 also includes the AUTOSTORE feature, a  
user selectable feature that automatically performs a  
High Reliability  
—Store Cycles: 1,000,000  
—Data Retention: 100 Years  
storeoperationwhenV fallsbelowapresetthreshold.  
CC  
Xicor NOVRAMs are designed for unlimited write opera-  
2
tionstoRAM,eitherfromthehostorrecallsfromE PROM  
andaminimum1,000,000storeoperations. Inherentdata  
retention is specified to be greater than 100 years.  
FUNCTIONAL DIAGRAM  
NONVOLATILE  
2
E PROM  
ORE  
ST  
STATIC  
RAM  
256-BIT  
RECALL (6)  
AS (7)  
CONTROL  
LOGIC  
RECALL  
ROW  
DECODE  
CS (1)  
INSTRUCTION  
SI (3)  
COLUMN  
DECODE  
SO (4)  
REGISTER  
SCK (2)  
INSTRUCTION  
DECODE  
4-BIT  
COUNTER  
2051 FHD F01  
AUTOSTORE™ NOVRAM is a trademark of Xicor, Inc.  
COPS is a trademark of National Semiconductor Corp.  
© Xicor, Inc. 1992, 1995, 1996 Patents Pending  
2051-1.5 8/1/97 T0/C0/D2 SH  
Characteristics subject to change without notice  
1
X25401  
PIN DESCRIPTIONS  
PIN CONFIGURATION  
Chip Select (CS)  
The Chip Select input must be LOW to enable all read/  
write operations. CS must remain LOW following a  
Read or Write command until the data transfer is com-  
plete. CS HIGH places the X25401 in the low power  
standby mode and resets the instruction register. There-  
fore, CS must be brought HIGH after the completion of  
an operation in order to reset the instruction register in  
preparation for the next command.  
DIP/SOIC  
CS  
SCK  
SI  
1
2
3
4
8
7
6
5
V
CC  
AS  
X25401  
RECALL  
SO  
V
SS  
Serial Clock (SCK)  
2051 FHD F02  
The Serial Clock input is used to clock all data into and  
out of the device.  
Serial Data In (SI)  
SI is the serial data input.  
PIN NAMES  
Serial Data Out (SO)  
Symbol  
CS  
SCK  
SI  
Description  
Chip Enable  
SO is the serial data output. It is in the high impedance  
state except during data output cycles in response to a  
READ instruction.  
Serial Clock  
Serial Data In  
Serial Data Out  
Recall Input  
AUTOSTORE Output  
+5V  
AUTOSTORE Output (AS)  
SO  
AS is an open drain output which, when asserted indi-  
RECALL  
AS  
cates V has fallen below the AUTOSTORE thresh-  
CC  
old (V  
). AS may be wire-ORed with multiple open  
ASTH  
V
V
CC  
SS  
drain outputs and used as an interrupt input to a micro-  
controller or as an input to a low power reset circuit.  
Ground  
2051 PGM T01  
RECALL  
RECALL LOW will initiate an internal transfer of data  
2
from E PROM to the RAM array.  
2
X25401  
DEVICE OPERATION  
reset upon power-up and must be intentionally set by  
the user to enable any write or store operations. Al-  
though a recall operation is performed upon power-up,  
the previous recall latch is not set by this operation.  
The X25401 contains an 8-bit instruction register. It is  
accessed via the SI input, with data being clocked in on  
the rising edge of SCK. CS must be LOW during the  
entire data transfer operation.  
WRDS and WREN  
Internally the X25401 contains a “write enable” latch.  
This latch must be set for either writes to the RAM or  
store operations to the E PROM. The WREN instruction  
Table 1 contains a list of the instructions and their  
operation codes. The most significant bit (MSB) of all  
instructions is a logic one (HIGH), bits 6 through 3 are  
either RAM address bits (A) or don’t cares (X) and bits  
2 through 0 are the operation codes. The X25401  
requires the instruction to be shifted in with the MSB  
first.  
2
sets the latch and the WRDS instruction resets the latch,  
2
disabling both RAM writes and E PROM stores, effec-  
tively protecting the nonvolatile data from corruption. The  
write enable latch is automatically reset on power-up.  
STO  
After CS is LOW, the X25401 will not begin to interpret  
the data stream until a logic “1” has been shifted in on  
SI. Therefore, CS may be brought LOW with SCK  
running and SI LOW. SI must then go HIGH to indicate  
the start condition of an instruction before the X25401  
will begin any action.  
The software STO instruction will initiate a transfer of  
data from RAM to E PROM. In order to safeguard  
against unwanted store operations, the following con-  
ditions must be true:  
2
• STO instruction issued.  
In addition, the SCK clock is totally static. The user can  
completely stop the clock and data shifting will be  
stopped. Restarting the clock will resume shifting of  
data.  
• The internal “write enable” latch must be set  
(WREN instruction issued).  
• The “previous recall” latch must be set (either a  
software or hardware recall operation).  
RCL and RECALL  
Once the store cycle is initiated, all other device func-  
tions are inhibited. Upon completion of the store cycle,  
the write enable latch is reset. Refer to Figure 4 for a  
state diagram description of enabling/disabling condi-  
tions for store operations.  
Either a software RCL instruction or a LOW on the  
RECALL input will initiate a transfer of E PROM data  
into RAM. This software or hardware recall operation  
sets an internal “previous recall” latch. This latch is  
2
TABLE 1. INSTRUCTION SET  
Instruction  
Format, I I I  
Operation  
2 1 0  
WRDS (Figure 3)  
STO (Figure 3)  
ENAS  
1XXXX000  
1XXXX001  
1XXXX010  
1AAAA011  
1XXXX100  
1XXXX101  
1AAAA11X  
Reset Write Enable Latch (Disables Writes and Stores)  
2
Store RAM Data in E PROM  
Enable AUTOSTORE Feature  
WRITE (Figure 2)  
WREN (Figure 3)  
RCL (Figure 3)  
READ (Figure 1)  
Write Data into RAM Address AAAA  
Set Write Enable Latch (Enables Writes and Stores)  
2
Recall E PROM Data into RAM  
Read Data from RAM Address AAAA  
2051 PGM T11  
X = Don’t Care  
A = Address  
3
X25401  
WRITE  
AUTOSTORE Feature  
The WRITE instruction contains the 4-bit address of  
the word to be written. The write instruction is immedi-  
ately followed by the 16-bit word to be written. CS must  
remain LOW during the entire operation. CS must go  
HIGH before the next rising edge of SCK. If CS is  
brought HIGH prematurely (after the instruction but  
before 16 bits of data are transferred), the instruction  
register will be reset and the data that was shifted-in  
will be written to RAM.  
The AUTOSTORE instruction (ENAS) sets the  
“AUTOSTORE enable” latch, allowing the X25401 to  
automatically perform a store operation when V falls  
CC  
below the AUTOSTORE threshold (V  
).  
ASTH  
WRITE PROTECTION  
The X25401 provides two software write protection  
mechanisms to prevent inadvertent stores of unknown  
data.  
Power-Up Condition  
If CS is kept LOW for more than 24 SCK clock cycles  
(8-bit instruction plus 16-bit data), the data already  
shifted-in will be overwritten.  
Upon power-up the “write enable” and “AUTOSTORE  
enable” latches are in the reset state, disabling any  
store operation.  
READ  
Unknown Data Store  
The READ instruction contains the 4-bit address of the  
word to be accessed. Unlike the other six instructions,  
The “previous recall” latch must be set after power-up.  
It may be set only by performing a software or hard-  
ware recall operation, which assures that data in all  
RAM locations is valid.  
I of the instruction word is a “don’t care”. This provides  
0
two advantages. In a design that ties both SI and SO  
together, the absence of an eighth bit in the instruction  
allows the host time to convert an I/O line from an  
output to an input. Secondly, it allows for valid data  
output during the ninth SCK clock cycle.  
SYSTEM CONSIDERATIONS  
Power-Up Recall  
All data bits are clocked by the falling edge of SCK  
(refer to Read Cycle Diagram).  
The X25401 performs a power-up recall that transfers  
the E PROM contents to the RAM array. Although the  
2
data may be read from the RAM array, this recall does  
not set the “previous recall” latch. During this power-up  
recall operation, all commands are ignored. Therefore,  
the host should delay any operations with the X25401  
LOW POWER MODE  
When CS is HIGH, non-critical internal devices are  
powered-down, placing the device in the standby power  
mode, thereby minimizing power consumption.  
a minimum of t  
after V is stable.  
PUR  
CC  
4
X25401  
Figure 1. RAM Read  
CS  
SCK  
SI  
1
1
2
3
4
5
6
7
8
9
10  
11  
12  
22  
23  
24  
A
A
A
A
1
1
X*  
HIGH Z  
SO  
D
D
D
D
D
D
D
D
0
1
2
3
13  
14  
15  
0
*Bit 8 of Read Instructions is Don’t Care  
2051 FHD F09.1  
Figure 2. RAM Write  
CS  
SK  
DI  
1
1
2
3
4
5
6
7
8
9
10  
11  
21  
22  
23  
24  
A
A
A
A
0
1
1
D
D
D
D
D
D
D
0
1
2
12  
13  
14  
15  
2051 FHD F10.1  
Figure 3. Non-Data Operations  
CS  
SCK  
SI  
1
2
3
4
5
6
7
8
1
X
X
X
X
I2  
I1  
I0  
2051 FHD F11.1  
5
X25401  
Figure 4. X25401 State Diagram  
POWER  
ON  
POWER-UP  
RECALL  
POWER  
OFF  
RAM READ  
RAM  
READ  
ENABLED  
RCL COMMAND  
OR RECALL  
AUTOSTORE  
POWER DOWN  
RAM READ  
RAM  
READ  
ENABLED  
STO OR  
WRDS CMD  
STO OR  
WREN  
WRDS CMD  
COMMAND  
RAM  
READ & WRITE  
ENABLED  
RAM READ  
OR WRITE  
RAM  
READ & WRITE  
ENABLED  
RAM READ  
OR WRITE  
ENAS COMMAND  
STORE ENABLED  
STORE  
ENABLED  
AUTOSTORE  
ENABLED  
WREN  
COMMAND  
2051 FHD F12.1  
6
X25401  
ABSOLUTE MAXIMUM RATINGS*  
*COMMENT  
Temperature under Bias .................. –65°C to +135°C  
Storage Temperature ....................... –65°C to +150°C  
Voltage on any Pin with  
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  
indicatedintheoperationalsectionsofthisspecificationis  
not implied. Exposure to absolute maximum rating condi-  
tions for extended periods may affect device reliability.  
Respect to V  
....................................... –1V to +7V  
SS  
D.C. Output Current ............................................. 5mA  
Lead Temperature  
(Soldering, 10 seconds).............................. 300°C  
RECOMMENDED OPERATING CONDITIONS  
Temperature  
Min.  
Max.  
Supply Voltage  
Limits  
Commercial  
Industrial  
Military  
0°C  
+70°C  
+85°C  
+125°C  
X25401  
5V ±10%  
2051 PGM T03.2  
–40°C  
–55°C  
2051 PGM T02.1  
D.C. OPERATING CHARACTERISTICS (Over recommended operating conditions unless otherwise specified.)  
Limits  
Symbol  
Parameter  
Min.  
Max.  
Units  
Test Conditions  
l
V
CC  
Supply Current  
10  
mA  
SCK = 0.4V/2.4V Levels @ 1MHz,  
CC1  
(TTL Inputs)  
SO = Open, All Other Inputs = V  
IH  
I
I
I
V
Supply Current  
2
1
mA  
mA  
µA  
All Inputs = V , CS = V  
IH IL  
CC2  
SB1  
SB2  
CC  
(During AUTOSTORE)  
SO = Open, V = 4.3V  
CC  
V
CC  
Standby Current  
SO = Open, CS = V ,  
IL  
(TTL Inputs)  
All Other Inputs = V  
IH  
V
CC  
Standby Current  
50  
SO = Open, CS = V  
SS  
(CMOS Inputs)  
All Other Inputs = V – 0.3V  
CC  
I
I
Input Load Current  
Output Leakage Current  
Input LOW Voltage  
Input HIGH Voltage  
Output LOW Voltage  
Output HIGH Voltage  
Output LOW Voltage (AS)  
10  
10  
µA  
µA  
V
V
V
= V to V  
SS CC  
LI  
IN  
= V to V  
CC  
LO  
OUT  
SS  
(1)  
V
V
V
V
V
–1  
2
0.8  
lL  
(1)  
V
+ 1  
CC  
V
IH  
0.4  
V
I
I
I
= 4.2mA  
OL  
OL  
2.4  
V
= –2mA  
OH  
OH  
0.4  
V
= 1mA  
OL (AS)  
OL(AS)  
2051 PGM T04.3  
ENDURANCE AND DATA RETENTION  
Parameter  
Min.  
Units  
Endurance  
100,000  
1,000,000  
100  
Data Changes Per Bit  
Store Cycles  
Years  
Store Cycles  
Data Retention  
2051 PGM T05  
CAPACITANCE T = +25°C, f = 1MHz, V = 5V  
A
CC  
Symbol  
Parameter  
Max.  
Units  
Test Conditions  
= 0V  
(2)  
C
OUT  
Output Capacitance  
Input Capacitance  
8
6
pF  
pF  
V
OUT  
(2)  
C
IN  
V
IN  
= 0V  
2051 PGM T06.2  
Notes: (1) V min. and V max. are for reference only and are not tested.  
IL  
IH  
(2) This parameter is periodically sampled and not 100% tested.  
7
X25401  
EQUIVALENT A.C. LOAD CIRCUIT  
A.C. CONDITIONS OF TEST  
5V  
Input Pulse Levels  
0V to 3V  
Input Rise and  
Fall Times  
919  
10ns  
1.5V  
Input and Output  
Timing Levels  
OUTPUT  
2051 PGM T07.1  
100pF  
497Ω  
2051 FHD F03  
A.C. CHARACTERISTICS (Over the recommended operating conditions unless otherwise specified.)  
Read and Write Cycle Limits  
Symbol  
Parameter  
Min.  
Max.  
Units  
(3)  
F
SCK Frequency  
1
MHz  
ns  
ns  
ns  
ns  
ns  
ns  
µs  
ns  
ns  
SK  
SCKH  
SCKL  
DS  
t
t
t
t
t
t
t
t
t
t
SCK Positive Pulse Width  
SCK Negative Pulse Width  
Data Setup Time  
400  
400  
400  
80  
Data Hold Time  
DH  
SCK to Data Bit 0 Valid  
SCK to Data Valid  
375  
375  
1
PD1  
PD  
Chip Select to Output High Z  
Chip Select Setup  
Z
800  
350  
800  
CSS  
CSH  
CDS  
Chip Select Hold  
Chip Deselect  
ns  
2051 PGM T08.1  
POWER-UP TIMING  
Symbol  
Parameter  
Max.  
Units  
(4)  
t
t
Power-up to Read Operation  
200  
5
µs  
PUR  
(4)  
Power-up to Write or Store Operation  
ms  
PUW  
2051 PGM T09  
Notes: (3) SCK rise and fall times must be less than 50ns.  
(4) t and t are the delays required from the time V is stable until the specified operation can be initiated. These parameters  
PUR  
PUW  
CC  
are periodically sampled and not 100% tested.  
8
X25401  
Write Cycle  
1/F  
SCK  
SCK CYCLE #  
SCK  
t
t
SCKH  
SCKL  
2
X
1
n
t
t
CDS  
t
CSH  
CSS  
CS  
SI  
t
t
DH  
DS  
2051 FHD F04.1  
Read Cycle  
SK CYCLE #  
6
7
8
9
10  
n
SCK  
CS  
t
PD  
12  
I1  
SI  
DON’T CARE  
t
PD1  
t
Z
HIGH Z  
HIGH Z  
SO  
D0  
D1  
Dn  
2051 FHD F05.1  
9
X25401  
NONVOLATILE OPERATIONS  
Previous  
Recall Latch  
State  
Software  
Instruction  
Write Enable  
Latch State  
Operation  
RECALL  
(5)  
Hardware Recall  
Software Recall  
Software Store  
0
1
1
NOP  
X
X
X
X
RCL  
STO  
SET  
SET  
2051 PGM T10  
ARRAY RECALL LIMITS  
Symbol  
Parameter  
Min.  
Max.  
Units  
t
t
t
Recall Cycle Time  
Recall Pulse Width  
2
µs  
ns  
ns  
RCC  
RCP  
RCZ  
(6)  
500  
Recall to Output in High Z  
500  
2051 PGM T11  
Recall Timing  
t
RCC  
t
RCP  
RECALL  
SO  
t
RCZ  
HIGH Z  
2051 FHD F06  
SOFTWARE STORE CYCLE LIMITS  
Symbol Parameter  
(7)  
Typ.  
Min.  
Max.  
Units  
t
ST  
Store Time After Clock 8 of STO Command  
2
5
ms  
2051 PGM T12.1  
Notes: (5) NOP designates when the X25401 is not currently executing an instruction.  
(6) Recall rise time must be <10µs.  
(7) Typical values are for T = 25°C and nominal supply voltage.  
A
10  
X25401  
AUTOSTORE Cycle Limits  
Symbol  
Parameter  
Min.  
Max.  
Units  
V
V
V
AUTOSTORE Cycle Time  
5
ms  
V
ASTO  
AUTOSTORE Threshold Voltage  
AUTOSTORE Cycle End Voltage  
4.0  
3.5  
4.3  
ASTH  
V
ASEND  
2051 PGM T13  
AUTOSTORE Cycle Timing Diagrams  
V
5
4
3
2
1
CC  
V
ASTH  
AUTOSTORE CYCLE IN PROGRESS  
V
ASEND  
t
ASTO  
STORE TIME  
TIME (ms)  
CC  
V
t
V
ASTH  
0V  
t
PUR  
t
PUR  
ASTO  
AS  
2051 FHD F08  
SYMBOL TABLE  
WAVEFORM  
INPUTS  
OUTPUTS  
Must be  
steady  
Will be  
steady  
May change  
from LOW  
to HIGH  
Will change  
from LOW  
to HIGH  
May change  
from HIGH  
to LOW  
Will change  
from HIGH  
to LOW  
Don’t Care:  
Changes  
Allowed  
Changing:  
State Not  
Known  
N/A  
Center Line  
is High  
Impedance  
11  
X25401  
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  
0.060 (1.52)  
0.020 (0.51)  
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)  
0.150 (3.81)  
0.125 (3.18)  
0.065 (1.65)  
0.045 (1.14)  
0.110 (2.79)  
0.090 (2.29)  
0.020 (0.51)  
0.016 (0.41)  
0.325 (8.25)  
0.300 (7.62)  
0.015 (0.38)  
MAX.  
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  
X25401  
PACKAGING INFORMATION  
8-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)  
0.019 (0.49)  
0.188 (4.78)  
0.197 (5.00)  
(4X) 7°  
0.053 (1.35)  
0.069 (1.75)  
0.004 (0.19)  
0.010 (0.25)  
0.050 (1.27)  
0.010 (0.25)  
0.050" TYPICAL  
X 45°  
0.020 (0.50)  
0.050"  
TYPICAL  
0° – 8°  
0.0075 (0.19)  
0.010 (0.25)  
0.250"  
0.016 (0.410)  
0.037 (0.937)  
0.030"  
TYPICAL  
8 PLACES  
FOOTPRINT  
NOTE: ALL DIMENSIONS IN INCHES (IN PARENTHESES IN MILLIMETERS)  
3926 FHD F22.1  
13  
X25401  
ORDERING INFORMATION  
X25401  
P
T
-V  
V
Limits  
Device  
CC  
Blank = 5V ±10%  
Temperature Range  
Blank = Commercial = 0°C to +70°C  
I = Industrial = –40°C to +85°C  
M = Military = –55°C to +125°C  
Package  
P = 8-Lead Plastic DIP  
S = 8-Lead SOIC  
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 tor 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.  
US. 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 back-up features to prevent such an occurrence.  
Xicor’s products are not authorized for use as 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. Acriticalcomponentisanycomponentofalifesupportdeviceorsystemwhosefailuretoperformcanbereasonablyexpectedtocausethefailure  
of the life support device or system, or to affect its satety or effectiveness.  
14  

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