A Product Line of Diodes Incorporated ZLDO1117 1A LOW DROPOUT POSITIVE REGULATOR 1.2V, 1.5V, 1.8V, 2.5V, 3.3V, 5.0V AND ADJUSTABLE OUTPUTS Description Pin Assignments ZLDO1117 is a low dropout positive adjustable or fixed-mode SOT223 regulator with 1A output current capability. The ZLDO1117 has a 2% tolerance across the industrial temperature range and is guaranteed to have lower than 1.2V dropout at full load current making it ideal to provide well-regulated outputs of 1.2V to 5.0V with input supply voltages up to 18V. The ZLDO1117 is ideally suited to provide well-regulated supplies for low voltage IC applications such as high-speed bus termination and low current 3.3V logic supply across the whole industrial temperature range. TO252 (Top View) Features * 1.2V Maximum Dropout at Full Load Current * 2% Tolerance Over Temperature, Line and Load Variations * Fast Transient Response 3 Vin 2 Vout 1 Adj (GND) Tab is Vout * Output Current Limiting * Built-in Thermal Shutdown * Good Noise Rejection * Suitable for use with MLCC Capacitors * Qualified to AEC-Q100 Grade 2 (see `Ordering Information') * PPAP capable (Note 4) * -40 to +125C Junction Temperature Range * Available in TO252 and SOT223 with "Green" Molding Compound (No Br, Sb) Lead-Free Finish; RoHS Compliant (Notes 1 & 2) Halogen and Antimony Free. "Green" Device (Note 3) Notes: 1. EU Directive 2002/95/EC (RoHS) & 2011/65/EU (RoHS 2) compliant. All applicable RoHS exemptions applied. 2. See http://www.diodes.com for more information about Diodes Incorporated's definitions of Halogen- and Antimony-free, "Green" and Lead-free. 3. Halogen- and Antimony-free "Green" products are defined as those which contain <900ppm bromine, <900ppm chlorine (<1500ppm total Br + Cl) and <1000ppm antimony compounds. 4. Automotive products are AEC-Q100 qualified and are PPAP capable. Automotive, AEC-Q100 and standard products are electrically and thermally the same, except where specified. Typical Applications Circuit 1A I/O - 1.8V Core Regulator 3.3V ZLDO1117-18 4.7F MLCC ZLDO1117 Document number: DS32018 Rev. 6 - 2 1.8V 4.7F MLCC 1 of 14 www.diodes.com July 2012 (c) Diodes Incorporated A Product Line of Diodes Incorporated ZLDO1117 Pin Descriptions Pin Name I/O Pin Number Adj (GND) I 1 VOUT O 2 VIN I 3 Function A resistor divider from this pin to the VOUT pin and ground sets the output voltage (Ground only for Fixed-Mode). The output of the regulator. A minimum of 4.7F capacitor (0.05 ESR 0.5) must be connected from this pin to ground to insure stability. For improved ac load response a larger output capacitor is recommended. The input pin of regulator. Typically a large storage capacitor (0.05 ESR 0.5) is connected from this pin to ground to ensure that the input voltage does not sag below the minimum dropout voltage during the load transient response. This pin must always be 1.3V higher than VOUT in order for the device to regulate properly. Absolute Maximum Ratings (@TA = +25C, unless otherwise specified.) Symbol VIN TJ TST Parameter Input Supply Voltage (Relative to Ground) Junction Temperature Power Dissipation Storage Temperature Rating -0.03 to +18 +150 See SOA Curve -65 to +150 Unit V C C Unless otherwise stated voltages specified are relative to the ANODE pin. 1.2 1 ILOAD (A) 0.8 0.6 SOA 0.4 0.2 0 0 5 10 15 VIN - VOUT (V) 20 25 Safe Operation Area (SOA) Curve ESD Susceptibility Symbol HBM MM Parameter Rating 4 400 Human Body Model Machine Model Unit kV V Stresses greater than the 'Absolute Maximum Ratings' specified above, may cause permanent damage to the device. These are stress ratings only; functional operation of the device at these or any other conditions exceeding those indicated in this specification is not implied. Device reliability may be affected by exposure to absolute maximum rating conditions for extended periods of time. Semiconductor devices are ESD sensitive and may be damaged by exposure to ESD events. Suitable ESD precautions should be taken when handling and transporting these devices ZLDO1117 Document number: DS32018 Rev. 6 - 2 2 of 14 www.diodes.com July 2012 (c) Diodes Incorporated A Product Line of Diodes Incorporated ZLDO1117 Recommended Operating Conditions (@TA = +25C, unless otherwise specified.) Symbol Parameter Min Max Unit 2.7 (Note 8) 18 V Output current 0.01 1 A Operating Junction Temperature Range (Note 5) -40 +125 C VIN Input voltage IO TJ Package Thermal Data Thermal Resistance Rating Unit Junction-to-Ambient, JA SOT223 (Note 6) TO252 (Note 7) 107 73 C/W Junction-to-Case, JC SOT223 (Note 6) TO252 (Note 7) 16 12 C/W Notes: Package 5. ZLDO1117 contains an internal thermal limiting circuit that is designed to protect the regulator in the event that the maximum junction temperature exceeded. When activated, typically at 150C, the regulator Output switches off and then back on as the die cools. 6. Test condition for SOT223: TA = +27C, no air flow, device mounted on 2"X2" polyimide PCB, 2 oz copper, 5.6mmX5.6mm pad. 7. Test condition for TO252: TA = +27C, no air flow, device mounted on 2"X2" polyimide PCB, 1 oz copper, 2cmX2cm pad. 8. Ensures correct operation without entering dropout. Device will continue to operate below this minimum input voltage under dropout conditions. Electrical Characteristics (@TA = +25C, unless otherwise specified.) Parameter Reference Voltage Conditions ZLDO1117-ADJ ZLDO1117-1.2 ZLDO1117-1.5 ZLDO1117-1.8 Output Voltage ZLDO1117-2.5 ZLDO1117-3.3 ZLDO1117-5.0 Line Regulation Notes: TA Min Typ Max (VIN-VOUT) = 2V, IO = 10mA 25 1.238 1.250 1.263 VOUT+1.4V < VIN< 10V, 10mA < IO< 1A FT 1.225 IO = 10mA, VIN = 3.2V 10mA< IO< 1A, 2.7V <VIN< 12V IO = 10mA, VIN = 3.5V 0 < IO< 1A, 2.9V <VIN< 12V IO = 10mA, VIN = 3.8V 25 FT 25 FT 25 1.188 1.176 1.485 1.470 1.782 0 < IO< 1A, 3.2V <VIN< 12V IO = 10mA, VIN = 4.5V 0 < IO< 1A, 3.9V <VIN< 12V IO = 10mA, VIN = 5.3V 0 < IO< 1A, 4.7V <VIN < 12V IO = 10mA, VIN = 7V FT 25 FT 25 FT 25 1.764 2.475 2.450 3.267 3.235 4.95 0 < IO< 1A, 6.4V <VIN < 12V FT 25 FT 25 FT 4.900 ZLDO1117-ADJ ZLDO1117-1.2 IO = 10mA, VOUT+1.5V<VIN<12V ZLDO1117-xx IO = 0mA, VOUT+1.5V<VIN<12V 1.275 1.200 1.500 1.800 2.500 3.300 5.000 1.212 1.224 1.515 1.530 1.818 1.836 2.525 2.550 3.333 3.365 5.05 5.100 0.1 0.2 0.1 0.2 Unit V V V V V V V % % 9. See thermal regulation specifications for changes in output voltage due to heating effects. Line and load regulation are measured at a constant junction temperature by low duty cycle pulse testing. Load regulation is measured at the output lead = 1/18" from the package. 10. Line and load regulation are guaranteed up to the maximum power dissipation of 15W. Power dissipation is determined by the difference between input and output differential and the output current. Guaranteed maximum power dissipation will not be available over the full input/output range. ZLDO1117 Document number: DS32018 Rev. 6 - 2 3 of 14 www.diodes.com July 2012 (c) Diodes Incorporated A Product Line of Diodes Incorporated ZLDO1117 Electrical Characteristics (cont.) (@TA = +25C, unless otherwise specified.) Parameter ZLDO1117-ADJ Load Regulation Dropout Voltage (VIN-VOUT) Current Limit Minimum Load Current (Note 8) Quiescent current Conditions VIN=3.3V,VADJ=0, 10mA<IO<1A, (Notes 9, 10) ZLDO1117-1.2 VIN=2.7V, 10mA < IO < 1A, (Notes 9, 10) ZLDO1117-1.5 VIN = 3V, 0 < IO< 1A, (Notes 9, 10) ZLDO1117-1.8 VIN = 3.3V, 0 < IO< 1A, (Notes 9, 10) ZLDO1117-2.5 VIN = 4V, 0 < IO< 1A, (Notes 9, 10) ZLDO1117-3.3 VIN = 4.8V, 0 < IO< 1A, (Notes 9, 10) ZLDO1117-5.0 VIN = 6.5V, 0 < IO< 1A, (Notes 9, 10) ZLDO1117ADJ/1.2/1.5/1.8/2.5/ 3.3/5.0 IO = 1A, VOUT = 1%VOUT ZLDO1117ADJ/1.2/1.5/1.8/2.5/ 3.3/5.0 ZLDO1117-ADJ ZLDO1117-1.2 ZLDO1117-xx TA 25 Typ Max 0.2 FT 0.4 25 FT 25 0.2 0.4 3 FT 25 FT 25 FT 25 FT 6 4 8 5 10 6.6 13 25 FT 25 10 20 1.2 1.11 0 ~ 125 1.3 FT 1.35 Unit % % mV mV mV mV mV V 25 (VIN-VOUT) = 5V A FT 1. 1 VIN = <18V FT 2 5 mA VIN< 18V, IO = 0mA FT 4 10 mA VIN = 7V FT 35 120 A 0.1 %/W GND current ZLDO1117-ADJ ZLDO1117-1.2 Thermal Regulation 30ms pulse 25 Ripple Rejection f = 120Hz, COUT = 25F Tantalum, IOUT = 100mA, ZLDO1117-XXX VIN = VOUT+3V 25 Temperature Stability IO = 10mA Notes: Min 60 80 dB 0.5 % 8. See thermal regulation specifications for changes in output voltage due to heating effects. Line and load regulation are measured at a constant junctiontemperature by low duty cycle pulse testing. Load regulation is measured at the output lead = 1/18" from the package. 9. Line and load regulation are guaranteed up to the maximum power dissipation of 15W. Power dissipation is determined by the difference between input and output differential and the output current. Guaranteed maximum power dissipation will not be available over the full input/output range. ZLDO1117 Document number: DS32018 Rev. 6 - 2 4 of 14 www.diodes.com July 2012 (c) Diodes Incorporated A Product Line of Diodes Incorporated ZLDO1117 Typical Characteristics 0.06 0.5 0.4 0.05 Adjustable version ILOAD = 10mA 0.3 Line Regulation (%) Vout (%) 0.2 0.1 0 -0.1 -0.2 VOUT+1.5V<VIN<12V, IOUT=10mA 0.04 0.03 0.02 0.01 -0.3 0 -0.4 -0.5 -40 -25 -10 5 20 35 50 65 80 95 110 125 -0.01 Temperature (C) -50 Output Voltage Variation vs. Temperature -25 0 25 50 Temperature (C) 75 100 125 Line Regulation vs. Temperature 0.25 1.4 1.3 VIN=3.3V, 10mA<IOUT<1A TJ = 25C VOUT = 1% of VOUT 1.2 Dropout voltage (V) Load Regulation (%) 0.2 0.15 0.1 1.1 1 0.9 0.8 0.05 0.7 0 0.6 -50 -25 0 25 50 Temperature (C) 75 100 125 0 Load Regulation vs. Temperature 0.2 0.4 IOUT (A) 0.6 0.8 1 Drop-Out Voltage vs. Current 70 Dropout vs Temperature 1.4 60 1.3 50 Dropout (V) IADJ (A) IOUT=1A VOUT = 1% of VOUT 1.2 1.1 40 30 1 20 0.9 10 0 0.8 -50 -25 0 25 50 Temperature (C) 75 100 125 -50 Document number: DS32018 Rev. 6 - 2 0 25 50 Temperature (C) 75 100 125 Adjust Pin Input Current Drop-Out Voltage vs. Temperature ZLDO1117 -25 5 of 14 www.diodes.com July 2012 (c) Diodes Incorporated A Product Line of Diodes Incorporated ZLDO1117 Typical Characteristics ZLDO1117-2.5V CIN = 1F, COUT = 10FTANT IPRELOAD = 100mA, Istep = 500mA ZLDO1117-2.5V CIN = 1F, COUT = 4.7F MLCC IPRELOAD = 100mA, ISTEP = 500mA 10mV 10mV 0 0 -10mV -10mV 600mA 600mA 100mA 100mA Transient Load Regulation with 10F Tantalum Capacitor Transient Load Regulation with 4.7F MLCC Capacitor ZLDO1117 2.5V CIN = 1F, COUT = 4.7F MLCC ILOAD = 100mA 10 0 5V 4V 10s/div Transient Line Regulation with 4.7F MLCC Capacitor 90 Ripple Rejection (dB) 85 80 75 ILOAD = 100mA, VIN - VOUT = 3V 70 65 60 55 50 10 100 1,000 Frequency (Hz) 10,000 100,000 Ripple Rejection ZLDO1117 Document number: DS32018 Rev. 6 - 2 6 of 14 www.diodes.com July 2012 (c) Diodes Incorporated A Product Line of Diodes Incorporated ZLDO1117 Application Information The ZLDO1117 family of quasi-LDO regulators is easy to use. They are protected against short circuit and thermal overloads. (see block diagram). Thermal protection circuitry will shut down the regulator should the junction temperature exceed +150C at the sense point. The ZLDO1117 is pin compatible with similar `1117 regulators and offers extended temperature range and improved regulation specifications. Operation The ZLDO1117 develops a 1.25V reference voltage between the output and the adjust terminal (see block diagram). By placing a resistor between these two terminals, a constant current is caused to flow through R1 and down through R2. For fixed output variants Resistors R1 and R2 are internal. Stability The ZLDO1117 requires an output capacitor as part of the device frequency compensation. As part of its improved performance over industry standard 1117 the ZLDO1117 is suitable for use with MLCC (Multi Layer Ceramic Chip) capacitors. A minimum of 4.7F ceramic X7R, 4.7F tantalum, or 47 F of aluminum electrolytic is required. The ESR of the output capacitor should be less than 0.5. Surface mount tantalum capacitors, which have very low ESR, are available from several manufacturers. When using MLCC capacitors avoid the use of Y5V dielectrics. Load Regulation For improved load regulation the ZLDO1117-ADJ should have the upper feedback resistor, R1, connected as close as possible to VOUT and the lower resistor, R2, connected as close as possible to the load GND return. This helps reduce any parasitic resistance in series with the load. Thermal Considerations ZLDO1117 series regulators have internal thermal limiting circuitry designed to protect the device during overload conditions. For continuous normal load conditions however, the maximum junction temperature rating of +125C must not be exceeded. It is important to give careful consideration to all sources of thermal resistance from junction to ambient. For the SOT223-3L and TO252-3L packages, which are designed to be surface mounted, additional heat sources mounted near the device must also be considered. Heat sinking is accomplished using the heat spreading capability of the PCB and its copper traces. The JC (junction to tab)of the TO252-3L and SOT223-3L are +12C/W and +16C/W respectively. Thermal resistances from tab to ambient can be as low as +30C/W. The total thermal resistance from junction to ambient can be as low as +42 to +46C/W. This requires a reasonable sized PCB with at least one layer of copper to spread the heat across the board and couple it into the surrounding air. Datasheet specifications using 2 oz copper and a 5mmx5mm pad with TA = +27C, no air flow yielded JA (junction to tab) of +73C/W and +107C/W for TO252-3L and SOT223-3L respectively. The thermal resistance for each application will be affected by thermal interactions with other components on the board. Some experimentation will be necessary to determine the actual value. Ripple Rejection When using the ZLDO1117 adjustable device the adjust terminal can be bypassed to improve ripple rejection. When the adjust terminal is bypassed the required value of the output capacitor increases. The device will require an output capacitor of 22F tantalum or 150F aluminum electrolytic when the adjust pin is bypassed. Normally, capacitor values on the order of 100F are used in the output of many regulators to ensure good load transient response with large load current changes. Output capacitance can be increased without limit and larger values of output capacitance further improve stability and transient response. The curves for Ripple Rejection were generated using an adjustable device with the adjust pin bypassed. These curves will hold true for all values of output voltage. For proper bypassing, and ripple rejection approaching the values shown, the impedance of the adjust pin capacitor, at the ripple frequency, should be < R1. R1 is normally in the range of 100 to 200. The size of the required adjust pin capacitor is a function of the input ripple frequency. At 120Hz, with R1 = 100, the adjust pin capacitor should be >13F. At 10kHz only 0.16F is needed. For fixed voltage devices, and adjustable devices without an adjust pin capacitor, the output ripple will increase as the ratio of the output voltage to the reference voltage (VOUT/VREF). For example, with the output voltage equal to 5V, the output ripple will be increased by the ratio of 5V/1.25V. It will increase by a factor of four. Ripple rejection will be degraded by 12dB from the value shown on the curve. ZLDO1117 Document number: DS32018 Rev. 6 - 2 7 of 14 www.diodes.com July 2012 (c) Diodes Incorporated A Product Line of Diodes Incorporated ZLDO1117 Typical Application Circuits Using R2 VOUT = 1.25 * 1 + R1 then the output voltage becomes: 330 VOUT = 1.25 * 1 + = 5.0 V 110 Figure 1 Basic Adjustable Regulator with 5V Output Figure 2 Adjustable Regulator with IADJ Errors R2 VOUT = 1.25 * 1 + + IADJ * R2 R1 Because IADJ typically is 55A, its effect is negligible in most applications. 330 VOUT = 1.25 * 1 + + 55 * 10 - 6 * 330 = 5.02 V ~ 0.4% 110 A. Output capacitor selection is critical for regulator stability. Larger Cout values benefit the regulator by improving transient response and loop B. CADJ can be used to improve ripple rejection. If CADJ is used, a Cout that is larger in value than CADJ must be used. C. Cin is recommended if ZLDO1117 is not located near the power supply filter. stability. D. An external diode is recommended to protect the regulator if the input instantaneously is shorted to GND. E. This device is designed to be stable with tantalum and MLCC capacitors with an ESR less than 0.47. ZLDO1117 Document number: DS32018 Rev. 6 - 2 8 of 14 www.diodes.com July 2012 (c) Diodes Incorporated A Product Line of Diodes Incorporated ZLDO1117 Other Application Circuits Figure 3 ZLDO1117 with Extended Output Voltage ZLDO1117 VIN IN VOUT OUT R1 121 1% ADJ C1 10 F TTL T1 MMBT3904 R3 1k R4 1k C2 100 F R2 365 1% Figure 4 ZLDO1117 with Disable Function ZLDO1117x50 AC IN IN OUT ADJ C1 10 F C2 100 F VOUT = -5V Figure 5 ZLDO1117 as a Negative LDO ZLDO1117 Document number: DS32018 Rev. 6 - 2 9 of 14 www.diodes.com July 2012 (c) Diodes Incorporated A Product Line of Diodes Incorporated ZLDO1117 Ordering Information Part Number ZLDO1117KTC ZLDO1117GTA ZLDO1117K12TC ZLDO1117G12TA ZLDO1117K15TC ZLDO1117G15TA ZLDO1117K18TC ZLDO1117G18TA ZLDO1117K25TC ZLDO1117G25TA ZLDO1117K33TC ZLDO1117G33TA ZLDO1117K50TC ZLDO1117G50TA ZLDO1117QKTC ZLDO1117QGTA ZLDO1117QK12TC ZLDO1117QG12TA ZLDO1117QK15TC ZLDO1117QG15TA ZLDO1117QK18TC ZLDO1117QG18TA ZLDO1117QK25TC ZLDO1117QG25TA ZLDO1117QK33TC ZLDO1117QG33TA ZLDO1117QK50TC ZLDO1117QG50TA Note: Output Voltage Adjustable 1.2V 1.5V 1.8V 2.5V 3.3V 5.0V Adjustable 1.2V 1.5V 1.8V 2.5V 3.3V 5.0V Packaging (Note 11) Status Reel Quantity Tape width Reel size TO252 Active 2500 16 mm 13" SOT223 Active 1000 12 mm 7" 13" TO252 Active 2500 16 mm SOT223 Active 1000 12 mm 7" TO252 Active 2500 16 mm 13" SOT223 Active 1000 12 mm 7" 2500 16 mm 13" TO252 Active SOT223 Active 1000 12 mm 7" TO252 Active 2500 16 mm 13" SOT223 Active 1000 12 mm 7" TO252 Active 2500 16 mm 13" SOT223 Active 1000 12 mm 7" TO252 Active 2500 16 mm 13" SOT223 Active 1000 12 mm 7" TO252 Active 2500 16 mm 13" SOT223 Active 1000 12 mm 7" 13" TO252 Active 2500 16 mm SOT223 Active 1000 12 mm 7" TO252 Active 2500 16 mm 13" SOT223 Active 1000 12 mm 7" 2500 16 mm 13" TO252 Active SOT223 Active 1000 12 mm 7" TO252 Active 2500 16 mm 13" SOT223 Active 1000 12 mm 7" TO252 Active 2500 16 mm 13" SOT223 Active 1000 12 mm 7" TO252 Active 2500 16 mm 13" SOT223 Active 1000 12 mm 7" 11. Pad layout as shown on Diodes Inc. suggested pad layout document AP02001, which can be found on our website at http://www.diodes.com/datasheets/ap02001.pdf. ZLDO1117 Document number: DS32018 Rev. 6 - 2 10 of 14 www.diodes.com July 2012 (c) Diodes Incorporated A Productt Line of Diodes Incorrporated D ZL LDO1117 Marking In nformation n TO252 SOT223 ZLDO1117 Document numberr: DS32018 Rev. 6 - 2 11 of 14 www.diodes.com w July 2012 2 (c) Diodes Incorporate ed A Product Line of Diodes Incorporated ZLDO1117 Package Outline Dimensions (All dimensions in mm.) SOT223 SOT223 Dim Min Max Typ A 1.55 1.65 1.60 A1 0.010 0.15 0.05 b1 2.90 3.10 3.00 b2 0.60 0.80 0.70 C 0.20 0.30 0.25 D 6.45 6.55 6.50 E 3.45 3.55 3.50 E1 6.90 7.10 7.00 e -- -- 4.60 e1 -- -- 2.30 L 0.85 1.05 0.95 Q 0.84 0.94 0.89 All Dimensions in mm A A1 TO252 E A b3 c2 L3 A2 D E1 H L4 A1 L e 2X b2 3X b ZLDO1117 Document number: DS32018 Rev. 6 - 2 a 12 of 14 www.diodes.com TO252 Dim Min Max Typ A 2.19 2.39 2.29 A1 0.00 0.13 0.08 A2 0.97 1.17 1.07 b 0.64 0.88 0.783 b2 0.76 1.14 0.95 b3 5.21 5.46 5.33 c2 0.45 0.58 0.531 D 6.00 6.20 6.10 D1 5.21 - - e 2.286 - - E 6.45 6.70 6.58 E1 4.32 - - H 9.40 10.41 9.91 L 1.40 1.78 1.59 L3 0.88 1.27 1.08 L4 0.64 1.02 0.83 a 0 10 - All Dimensions in mm July 2012 (c) Diodes Incorporated A Product Line of Diodes Incorporated ZLDO1117 Suggested Pad Layout SOT223 X1 Dimensions X1 X2 Y1 Y2 C1 C2 Y1 C1 Value (in mm) 3.3 1.2 1.6 1.6 6.4 2.3 Y2 C2 X2 TO252 X2 Dimensions Z X1 X2 Y1 Y2 C E1 Y2 C Z Y1 X1 ZLDO1117 Document number: DS32018 Rev. 6 - 2 Value (in mm) 11.6 1.5 7.0 2.5 7.0 6.9 2.3 E1 13 of 14 www.diodes.com July 2012 (c) Diodes Incorporated A Product Line of Diodes Incorporated ZLDO1117 IMPORTANT NOTICE DIODES INCORPORATED MAKES NO WARRANTY OF ANY KIND, EXPRESS OR IMPLIED, WITH REGARDS TO THIS DOCUMENT, INCLUDING, BUT NOT LIMITED TO, THE IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE (AND THEIR EQUIVALENTS UNDER THE LAWS OF ANY JURISDICTION). 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Life support devices or systems are devices or systems which: 1. are intended to implant into the body, or 2. 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 significant injury to the user. B. A critical component is any component in a life support device or system whose failure to perform can be reasonably expected to cause the failure of the life support device or to affect its safety or effectiveness. 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