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YY 0781-2010: Blood pressure transducers
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Blood pressure transducers
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Basic data | Standard ID | YY 0781-2010 (YY0781-2010) | | Description (Translated English) | Blood pressure transducers | | Sector / Industry | Medical Device & Pharmaceutical Industry Standard | | Classification of Chinese Standard | C39 | | Classification of International Standard | 11.040.55 | | Word Count Estimation | 23,297 | | Date of Issue | 2010-12-27 | | Date of Implementation | 2012-06-01 | | Quoted Standard | GB 9706.1-2007; GB/T 1962.1-2001; GB/T 1962.2-2001 | | Adopted Standard | ANSI/AAMI BP22-1994, MOD | | Regulation (derived from) | State Food and Drug Administration Notice 2010 No. 97 | | Issuing agency(ies) | State Food and Drug Administration | | Summary | This standard applies to direct vascular catheter or puncture to measure blood pressure sensors, including cable. Although the requirements of this standard and the test is designed around the expected use of blood pressure measurement devices for research and design, but the blood pressure measurement of physiological parameters than can also use this sensor. Even though this standard focuses on blood pressure measurement sensors safety and efficacy, attention should also ensure that special sensors and blood pressure monitoring equipment compatibility. Scope of this standard is designed to measure blood pressure include indwelling catheter or by direct puncture of the sensor, cable safety and performance requirements, but also to the user to decide between the sensor and blood pressure monitoring device compatibility reference. Scope of this standard does not include the other is designed for measuring physiological parameters of the sensor, this standard does not elaborate sensors or monitoring equipment for the operation of the program, therefore, refer to the appropriate instruction manual for proper installation, balancing and calibration of the system is absolutely necessary The. | YY 0781-2010: Blood pressure transducers---This is a DRAFT version for illustration, not a final translation. Full copy of true-PDF in English version (including equations, symbols, images, flow-chart, tables, and figures etc.) will be manually/carefully translated upon your order.
Blood pressure transducers
ICS 11.040.55
C39
People's Republic of China Pharmaceutical Industry Standard
Blood pressure sensor
Released on.2010-12-27
2012-06-01 implementation
Issued by the State Food and Drug Administration
Table of contents
Foreword Ⅰ
1 Scope 1
2 Normative references 1
3 Definition 1
4 Requirements 3
5 test 5
Appendix A (informative appendix) The principle explanation of the development and proposal of this standard 14
Figure 1 The relationship between the standard accuracy error band of the blood pressure sensor and the applied pressure 5
Figure 2 Synchronous demodulator 6
Figure 3 Time course of combined test of drift, zero pressure temperature error band and sensitivity temperature error band 7
Figure 4 Circuit test connection 8
Figure 5 Frequency response parameter test 9
Figure 6 Oscilloscope common mode test 10
Figure 7 Oscilloscope phase shift test (the accuracy of all resistors is 1%) 10
Figure 8 Phase shift measurement Figure 11
Figure 9 Leakage current test 12
Figure 10 Defibrillator tolerance test 13
Foreword
This standard uses the translation method to modify the American National Standard ANSI/AAMIBP22.1994 "Blood Pressure Sensor".
The main difference between this standard and ANSI/AAMIBP22.1994.Leakage current limit This standard is based on GB 9706.1-2007, ANSI/
The AAMIBP22.1994 standard is based on ANSI/AAMIBS1-1.
This standard has also made the following editorial changes. For other international standards cited in the standard, if they have been converted into Chinese standards accordingly, then
Subject to the quoted Chinese standards.
This standard is organized by the National Medical Electrical Appliance Standardization Technical Committee Medical Electronic Instrument Standardization Subcommittee (SAC/TC10/SC5)
Focus.
Drafting organizations of this standard. Shenzhen Mindray Biomedical Electronics Co., Ltd., Shanghai Medical Device Testing Institute.
The main drafters of this standard. Ye Jilun, Shi Daifeng.
Blood pressure sensor
1 Scope
This standard applies to pressure sensors that measure blood pressure via catheter or direct vascular puncture, including cables. Despite the requirements of this standard
And the test is developed and designed around the equipment with blood pressure measurement as its intended use, but the measurement of physiological parameters other than blood pressure
This sensor can also be used. Even if this standard focuses on the safety and efficacy of sensors for blood pressure measurement, it should also focus on ensuring dedicated sensors.
Compatibility of monitor and blood pressure monitoring equipment.
The scope of this standard covers the safety and performance of indwelling catheters or directly punctured sensors and cables designed to measure blood pressure.
At the same time, it also provides a reference for users to decide the compatibility between sensors and blood pressure monitoring equipment.
The scope of this standard does not include sensors that are designed to measure other physiological parameters. This standard does not elaborate on sensors or monitoring
The operating procedures of the equipment, therefore, referring to the appropriate instruction manual is absolutely necessary for the correct installation, balancing and calibration of the system.
Note. Please refer to Appendix A for the principle explanation of the formulation of the clauses and requirements of this standard.
2 Normative references
The clauses in the following documents become clauses of this standard after being quoted in this standard. For dated reference documents, all subsequent
The amendments (not including errata content) or revisions do not apply to this standard. However, all parties who have reached an agreement based on this standard are encouraged to study
Is the latest version of these files available? For undated references, the latest version is applicable to this standard.
GB 9706.1-2007 Medical electrical equipment Part 1.General requirements for safety (IEC 60601-1.1988, IDT)
GB/T 1962.1-2001 Syringes, injection needles and other medical devices 6% (Luer) tapered joints Part 1.General requirements
(ISO 594-1.1986, IDT)
GB/T 1962.2-2001 Syringes, injection needles and other medical devices 6% (Luer) tapered joints Part 2.Locking joints
(ISO 594-2.1998, IDT)
3 definition
The following terms and definitions apply to this standard.
3.1
Accuracy
The ratio of error (measured value minus true value) to true value (or theoretical value), expressed as a percentage.
3.2
Balance
When properly excited, the symmetry of the Wheatstone bridge or the zero condition of the output from the bridge.
3.3
Critical damping
The damping value required for the minimum settling time of a step input without overshoot.
3.4
Damping
An energy dissipation characteristic that determines the upper limit of the frequency response and response time of the sensor together with the natural frequency.
3.5
Damping coefficient
The ratio of the actual damping value to the critical damping value.
3.6
Force-sensitive membrane diaphragm
The sensing element is composed of a thin film between two volumes. The pressure difference between the two sides of the film will cause its deformation.
3.7
Electricalcalibration
Attached equipment calibration. In this process, through a calibration resistor placed on a bridge arm of the bridge, or placed in the excitation circuit
Press a proportional voltage divider to deliberately generate the electrical imbalance of the sensor to simulate a known pressure.
3.8
Incentive
The external voltage or current applied to make the sensor work normally.
3.9
Excitationimpedance
input resistance
The excitation source impedance measured from the sensor excitation terminal.
3.10
Frequency response frequencyresponse
When a sinusoidal pressure is input, the output amplitude ratio changes. For a two-order system, the frequency response is composed of the undamped natural frequency and
The damping coefficient is jointly determined.
3.11
15% passband 15 ndwidth
The frequency response amplitude corresponding to this frequency band is within ±15% of the flat low-pass frequency amplitude.
3.12
Hysteresis
The pressure input of a given value in a range, and when the positive stroke and the reverse stroke are close to the pressure value, a pressure measurement
The maximum difference output by the measuring device.
3.13
Point-based linearity
Non-linearity is expressed as the degree of deviation from a certain straight line passing through a given point or multiple points.
3.14
Resistive bridge sensor resistivebridgetransducer
The sensor can accept DC or AC current excitation, and its output is directly proportional to the product of applied pressure and excitation.
3.15
Resonantfrequency
Undamped natural frequency
When the damping coefficient of an electrical or mechanical system (second-order) is zero, the system will oscillate at a frequency.
3.16
Sensitivity
Under a given excitation voltage, the ratio of the change in sensor output to the change in pressure.
3.17
Signal impedance signalimpedance
Output impedance
The effective impedance that is connected across the output of the sensor and presented to the associated external circuit.
3.18
Symmetry
In the center of the sensor common-mode signal output between the excitation voltages.
4 requirements
4.1 Labeling requirements
The term "identification" refers to the printed text or marks that appear on the equipment, accessories or packaging, and all accompanying documents. In addition to regulations
In addition to the requirements applicable to the identification of all medical devices, the requirements contained in this article also apply to the equipment included in the scope of this standard.
4.1.1 Equipment marking
The equipment (or packaging, such as the outer packaging of disposable equipment) should be permanently and conspicuously marked with the following information.
a) Model;
b) manufacturer's name;
c) Serial number or other manufacturing control identification code;
d) Reusable electronic components should be marked with serial numbers or other control identification codes.
4.1.2 Manual
An instruction manual should be provided for each sensor or reusable cable, or in the case of multiple pieces, the instruction manual should be configured according to the order.
The instruction manual should include at least the following information.
a) Excitation voltage (or voltage range);
b) Excitation frequency (or frequency range);
c) The excitation impedance or the characteristics of the components at the excitation voltage and frequency specified in a) and b);
d) Sensor signal output impedance with certain tolerance;
e) If applicable, the maximum phase deviation or phase frequency characteristics within the excitation frequency range specified in b);
f) The nominal sensitivity of the ideal sensor output;
g) The sensor cable connected to the monitor connector and the corresponding monitor manufacturer, including a wiring board, makes the sensor connection
To the monitor to ensure convenient operation and safety;
h) Precautions and warnings about the storage, use, operation and sterilization of sensor components;
i) A list of accessories recommended for use with the sensor, including pressure transmission diaphragm, mounting brackets and other devices;
j) Recommended operating procedures for connecting the sensor to the hydraulic system;
k) If applicable, detailed instructions for the cleaning and sterilization of sensors, pressure transmission diaphragms and other related components;
l) In order to ensure the functional integrity of the equipment, instructions for the use, attention, storage, operation and maintenance of the sensor;
m) The name and address of the organization that can accept customer service;
n) The acceleration of the half-sine shock that the sensor can withstand on each axis, and still meet the requirements of 4.2, 4.2.3.7
The zero calibration range given may be increased to 150mmHg;
o) Under the condition of 25℃±1℃, within 4h after the recommended warm-up time, deviation from the maximum value of the initial sensor zero output,
Expressed in mmHg;
p) After the recommended warm-up time, the error of zero drift when the temperature changes from 25℃~15℃ and from 25℃~40℃
Range, expressed in mmHg;
q) The error range of sensitivity when the temperature changes from 25°C to 15°C and from 25°C to 40°C, relative to the sensitivity at 25°C
Expressed as a percentage;
r) Sensitivity of the sensor under the conditions of zero pressure (mmHg) input and 3300lx from a 3400K tungsten light source
The maximum error within the nominal excitation voltage range should be nominal.
4.2 Sensor performance requirements
4.2.1 Environmental performance
Unless otherwise specified, when the storage temperature is -25℃~70℃, the sensor should meet the performance requirements of 4.2 and its work
The conditions are as follows.
a) Working temperature. 15℃~40℃;
b) Humidity. 10%~90%, under non-condensing conditions;
c) Atmospheric pressure. 567kPa~1130kPa.
4.2.2 Mechanical requirements
When used together with the accessories or pressure transmission diaphragm recommended by the sensor manufacturer, and apply these accessories or
When transmitting pressure diaphragm, the following requirements cover the entire structure of this pressure sensor.
4.2.2.1 Pressure range
The sensor should work normally within the entire range of -30mmHg~300mmHg, and within -400mmHg~4000mmHg
It should not be damaged under the range of overvoltage conditions.
4.2.2.2 Installation requirements
When installed on any axis, the sensor should meet the performance requirements of 4.2.
4.2.2.3 Requirements for accessories
Luer connector or Linden connector meets the requirements of standards GB/T 1962.1-2001 and GB/T 1962.2-2001.
The adapter should enable the sensor to be connected to the needle or catheter.
4.2.2.4 Frequency response
All the integrated, reusable or disposable pressure transmission diaphragms recommended by the manufacturer are based on standards when operating in accordance with the manufacturer’s recommended procedures
"Evaluation of invasive blood pressure monitoring clinical systems" (AAMITIR9, Evaluation of clinical systems for invasive blood pres-
The frequency response of the 15% passband specified in suremonitoring) shall not be less than.200Hz.
4.2.3 Electrical performance
This article describes the electrical performance requirements of the functional monitoring system when the sensor or interface is coupled to a blood pressure monitoring device.
4.2.3.1 Sensor excitation
When the excitation is from direct current (DC) to 5000Hz and is in the range of 4V~8V (rms); or as noted in the instruction manual
Given the excitation voltage and frequency (range), the sensor should meet the requirements of 4.2.
4.2.3.2 Phase shift
In the case of sinusoidal excitation, within the excitation frequency range, the phase offset between the sensor's excitation and the signal (including cable) should be less than 5°, or
The relevant phase offset or phase characteristics should be indicated in the instruction manual.
Warning. The capacitive imbalance should be compensated to avoid affecting the phase shift measurement.
4.2.3.3 Sensor excitation impedance
For the excitation source from DC to 5000Hz, the excitation impedance of the sensor should be greater than.200Ω, or the needle should be indicated in the instruction manual.
The excitation impedance for the frequency range used.
4.2.3.4 Sensor signal (output) impedance
For the excitation source from DC to 5000Hz, the sensor signal output impedance should be less than 3000Ω, or the user manual should indicate the pin
The signal output impedance for the frequency range used.
4.2.3.5 Sensor symmetry
The increased impedance of any calibration or compensation bridge should be separated and maintain the common mode symmetry of the signal output terminal and the excitation terminal within ±5%
Internally, symmetry does not require a non-resistive sensor.
4.2.3.6 Sensitivity
Use the nominal sensitivity of 5μV/V/mmHg or use the sensitivity specified in the instruction manual to determine the accuracy of 4.2.3.8
Ideal output.
4.2.3.7 Maladjustment
For the sensor installed on any axis, its offset should be able to be adjusted internally within the range of ±75mmHg.
Note. The manufacturer of monitoring equipment should provide an adjustment range from 150mmHg to -150mmHg for pressure imbalance.
4.2.3.8 Accuracy (sexuality)
The total error of sensitivity, repeatability, nonlinearity and hysteresis should be less than ±1% of the reading of ±1mmHg (pressure range. -30mmHg~
50mmHg) or ±3% of the reading (pressure range. 50mmHg~300mmHg), the above error is taken into account in 4.2.3.6
The ideal output calculated from the nominal sensitivity should be measured afterwards (see Figure 1).
Figure 1 The relationship between the standard accuracy error band of the blood pressure sensor and the applied pressure
4.2.4 Safety requirements
4.2.4.1 Liquid isolation
The sensor (without isolation pressure diaphragm) should maintain electrical isolation between the liquid column and the container and all electrical terminals connected together.
Note. If the amplifier and sensor are provided by the sensor manufacturer as a system, the considerations are as in 4.2.4.1, 4.2.4.2 and 4.2.4.3
The liquid isolation requirements described are met by an isolation amplifier. Complete the test on the designated connector that can be connected to the monitor.
4.2.4.2 Leakage current
Add 110% of the grid power rating between the liquid column, the housing (bare metal, or any other) and the connected terminals
The limit of voltage and leakage current should meet the limit requirements of patient leakage current (applied part of the grid power supply voltage) specified in GB 9706.1-2007.
4.2.4.3 Defibrillation prevention
The sensor should withstand the discharge of a damped sine wave with an energy of 360J repeated 5 times within 5 minutes. When the fluid surface of the sensor is connected
When connected to one side, the cardiac defibrillation device is released to 50Ω, and at the same time the liquid column of the sensor is connected to one end of the 50Ω load, and the shell (bare metal)
Connect the other end of the load.
If there is a significant warning label on the sensor assembly that contains the following content, this requirement can be exempted.
Note. This pressure sensor does not have anti-defibrillation function, it must only be used for monitoring with patient interface marked as having anti-defibrillation function
equipment.
4.3 Cable requirements
The connecting cable assembly between the sensor and the cable connector should meet the following requirements.
a) The manufacturer shall announce the length of the cable;
b) The cable assembly should provide a vent for the sensor, so that the sensor measures the pressure relative to the atmospheric pressure;
c) The cable assembly should withstand (if there is no breakdown) within 5 minutes a damped sine wave discharge with an energy of 360J repeated 5 times. core
The wires are connected together at one end of the 50Ω load, and the cable sheath is wrapped with a 15cm-long metal foil to connect to the other end of the load.
5 test
This chapter will introduce the test methods and test procedures that can verify the sensor's compliance with the performance requirements of Chapter 4.These test routines
(Or equivalent test) can be suitable for design verification, but it is not necessary for quality assurance purposes or for testing in this field.
Required. Most of these tests are applicable to resistance strain type sensors and alternating current (AC) bridge type sensors. The manufacturer can use
Alternative technology to perform equivalent tests on test sensors. Except for the first number, the serial numbers of the articles in this chapter will correspond to those in Chapter 4.
The required serial number. For example. the test of 5.2.3 will determine the compliance with the standard of 4.2.3.For certain requirements, the compliance test can pass the visual
These will be explained in appropriate places. The conventional instruments and procedures for implementing these tests will be described next.
Test conditions. Unless otherwise specified, all measurements and tests should be within the rated temperature range of 20℃~25℃ and maintained
Within ±1℃ of the rated temperature (measurement accuracy is 0.25℃), 40%±20% relative humidity and 425mmHg~850mmHg
It is done under air pressure.
Combined test. Since the temperature characteristics of the sensor are included in the requirements, several tests need to be performed at different temperatures to confirm this
Some requirements. It should be noted that during each temperature operation in these combined tests, it is allowed to determine the temperature characteristics of the sensor and the entire
Operating characteristics of temperature range.
Test equipment. The following test equipment is required.
a) A differential input amplifier with a common-mode rejection ratio of at least 60dB in the 5kHz range, with a minimum input impedance of 1MΩ.
A dual-channel oscilloscope with a phase shift of less than 1° at 5kHz.
b) One can measure AC/DC voltage from 1mV to 10V, and has an input impedance greater than 10MΩ, 1μV resolution
Rate, and 0.1% reading accuracy of the digital voltmeter.
c) A signal generator capable of generating sine waves with a frequency range of 5000Hz. This signal generator should have a negative
Under load, the adjustable voltage output rises to a minimum of 10V (rms). Relative to the earth, the output voltage is floating, and
There is a minimum insulation resistance of 2MΩ to the earth at 5kHz.
d) A defibrillator that can apply a 360J damped sine wave to a 50Ω load.
e) A pressure source with an accurate range that can provide and read up to 300mmHg and accurate to ±0.2% at 100mmHg.
f) A vacuum pump that can provide up to -400mmHg and an accuracy of ±0.2% at -30mmHg.
g) A pressure waveform generator capable of generating a 25mmHg square wave pressure signal at 2Hz.
h) A can work beyond the excitation voltage and frequency range mentioned in 4.2.3.1, and the additional effect is less than
For a synchronous demodulator with ±0.5mmHg and a reading error of less than 0.2%, this test circuit is shown in Figure 2.
Note 1.Beckman resistor network 692-3-R1K-B.
Note 2.The cutoff frequency (-3dB) formed by R5, R6 and C6 is a low-pass filter at 338Hz.
Note 3.The input of the multimeter must be floating.
Note 4.All resistors are of type RN55D and expressed in ohms, and all capacitances are expressed in microfarads.
Figure 2 Synchronous demodulator
5.1 Marking requirements
Compliance with many labeling requirements of 4.1 can be determined by visual inspection. In order to verify the disclosure required in 4.1.2
Technical information, test procedures are necessary.
5.1.1 Equipment marking
The compliance verification required by 4.1.1 can be obtained through visual inspection.
5.1.2 Manual
The compliance of parts h) to m) in 4.1.2 can be verified by checking the instruction manual. Performance indicators from b) to g)
It is taken from the results obtained in the test procedures 5.2.3.1~5.2.3.4 and 5.2.3.6.
n) The sensor needs to withstand a half-sine shock on each axis. The magnitude of the acceleration should be equal to the nominal value. Experiencing
After these continuous shocks, test the imbalance (5.2.3.7), accuracy (5.2.3.8) and safety (5.2.4) of this sensor
Etc., the performance of the sensor should be consistent with the requirements in 4.2.3.7, 4.2.3.8 and 4.2.4.
o), p) and q) The following program combines the temperature error range for drift, zero pressure and sensitivity temperature error range
Test (see Figure 3).
Figure 3 Time course of combined test of drift, zero pressure temperature error band and sensitivity temperature error band
1) Equilibrate all parts at 25℃±1℃ for 2h.
2) Connect the pressure transmission diaphragm and other necessary parts of the measuring system, and fill them with distilled water.
3) Connect this sensor to the excitation source and digital multimeter (DMM) as shown in Figure 4, and set the digital multimeter to DC
20V range. Set switch S3 to the excitation (EXC) end, adjust the excitation source to output DC 6V voltage or frequency as
2.5kHz 6V AC sinusoidal signal (6.664rms), or set according to the manufacturer's instructions.
Note. The output of the synchronous demodulator circuit at V3 is equivalent to a full-wave rectified signal. For sinusoidal excitation, the reading is equivalent to a
The average value of the half period. The average sine value of one half cycle of the excitation voltage (hereinafter referred to as the AC average value) can also be used for any follower
No. output voltage to the conversion of equivalent mmHg readings. The synchronous demodulator circuit is also used for DC excitation, but it can be used in the special measurement for DC.
Try to get rid of. The conversion formula from RMS to AC average sine is.
AC average = effective value × 0.9003
4) Set DMM to DC 20mV range, turn switch S3 to TEST terminal, and measure the output signal.
5) Record the initial non-equilibrium reading (Z1), and start a 4h test cycle at 25℃±1℃. Plot under zero pressure
Output trend graph, and record the maximum value (unit. mmHg) that deviates from the initial reading during this time period.
6) Record the output readings of zero pressure and 100mmHg pressure changes as Z2 and S1 (refer to 5.2.3.6). Set up an environmental temperature control room
The temperature is 15°C. After waiting for 1h, the room temperature is constant within 15℃±1℃, and then record zero pressure and 100mmHg
Output readings of pressure changes (Z3 and S2). Following the same operation, change the temperature to 25°C, then to 40°C, and then back to
25℃, measure the output readings (Z4, Z5 and Z6) at each point under zero pressure, and measure at 100mmHg pressure change
40°C output reading (S3).
The zero-point drift error (expressed in mmHg) is the maximum value that deviates from the Z1 data point in more than 4 hours of measurement. Zero drift corresponding to temperature
The shift error band (expressed in mmHg) is the larger value among (Z3-Z2), (Z4-Z2), (Z5-Z2), (Z6-Z2). Corresponding to temperature
The sensitivity changes are.
(S2-S1)
S1 ×
100 or ±
(S3-S1)
S1 ×
100%
The larger of the two.
Figure 4 Circuit test connection
r) Prepare the sensor and a 3400K tungsten light source that can emit 914lx. Use the recommended excitation lev...
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