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Detail Information of YY/T 1095-2015; YY/T1095-2015
Description (Translated English): Myoelectric biofeedback equipment
Word Count Estimation: 13,193
Older Standard (superseded by this standard): YY/T 1095-2007
Quoted Standard: GB 9706.1-2007; GB 9706.15-2008; GB/T 14710-2009; GB/T 16886.1-2011; YY 0505-2012
Drafting Organization: China Food & Drug Administration Tianjin Medical Devices Inspection Center
Administrative Organization: National Medical Electrical Standardization Technical Committee of physical therapy equipment Sub-Technical Committee
Summary: This Standard specifies the EMG biofeedback instrument of terms and definitions, classification, requirements, test methods. 3.1 This Standard applies to the provisions of muscle anti instrument. This Standard does not apply to the use of a needle electrode recording instruments and EMG evoked potential.
Myoelectric biofeedback equipment
Replacing YY/T 1095-2007
EMG biofeedback instrument
The standard safety requirements for full implementation of the GB 9706.1-2007 "Medical Electrical Equipment Part 1: General requirements for safety" and
GB 9706.15-2008 "Medical electrical equipment - Part 1-1: General Requirements for Safety Collateral Standard: Safety requirements for medical electrical systems."
Instead of the standard YY/T 1095-2007 "EMG biofeedback instrument."
This standard YY/T 1095-2007 Comparison with main technical differences are as follows:
--- Modify the scope of this standard (see Chapter 1);
--- Increasing the classification (see Chapter 4);
--- Modify the feedback indication requirements, test methods (see 52, 62, 2007 edition 4.2.7,5.2.);
--- Added feedback threshold requirements and test methods (see 5.3,6.3);
--- Increased the frequency noise suppression requirements and test methods (see 5.4,6.3);
--- Remove the original requirements and test methods for measuring range (2007 Edition 4.2.1,5.3.1);
--- Indication of increased accuracy requirements and test methods (see 5.5.2,6.5.1);
--- Deleted the original sensitivity requirements (2007 Version 4.2.8);
--- Increasing the requirements and test methods for resolution (see 5.5.3,6.5.2);
--- Modify the requirements and test methods for pass band (see 555, 654, 2007 edition 4.2.4,5.3.4....);
--- Increased the requirements and test methods for frequency notch filter (see 5.5.8,6.5.7);
--- Deleted the original isolation requirements (2007 Version 4.2.9);
--- Increased safety requirements (see 5.8);
--- Increased use of the content and requirements specification (see 5.7);
--- Added Appendix Important Legal Information of guidelines and principles (see Appendix A).
The main drafters of this standard: Juan Yang, Han desert, Duan Chuan Ying, Sun Huili, Liu Hui, Yuan Xiaobing.
--- YY 91095-1999;
--- YY/T 1095-2007.
This standard specifies the EMG biofeedback device (hereinafter referred to as the anti-muscle meter) terms and definitions, classification, requirements, test methods.
3.1 This standard applies to the provisions of the anti-muscle apparatus.
This standard does not apply to the use of a needle electrode EMG recording instruments and EMG evoked potential.
GB 9706.15-2008 Medical electrical equipment - Part 1-1: General Requirements for Safety Collateral Standard: Safety of medical electrical systems
GB/T 16886.1-2011 Biological evaluation of medical devices - Part 1: Evaluation of the risk management process and Test
YY 0505-2012 Medical electrical equipment - Part 1-2: General requirements for safety Collateral standard: Electromagnetic compatibility requirements and tests
Using a surface electrode EMG collection body as physiological information, and other forms of visual or auditory feedback to the patient, so that patients can learn
Conscious control of their own psychological and physiological activity to treat diseases of the instrument.
Surface electrode surfaceelectrode
On the skin surface (or cavity surface) for acquiring noninvasive detection of EMG electrodes.
Display System displaysystem
In addition to the anti-muscle instrument display indicates feedback, but also provides the means to display EMG amplitude.
Feedback response frequency feedbackresponsefrequencybands
You can achieve the desired feedback response frequency range.
Feedback threshold feedbackthreshold
Amplitude response to achieve different degrees when.
Classification by structure: can be divided into a display system and a display system without anti-muscle apparatus.
Shall comply with the manufacturer's specifications; if not specified, shall meet the requirements of Chapter 10 of GB 9706.1-2007.
5.2 feedback indicates
Feedback should comply with instructions 5.7f) use described in the specification.
5.3 feedback threshold accuracy
Feedback threshold shall be specified by the manufacturer, when the center frequency measurement error should not exceed ± 10% of nominal value.
5.4 frequency noise suppression
At the input of the superposition of a muscle group of anti-meter amplitude of 100μV - when frequency sinusoidal signal (peak-valley), the feedback indicates that should not be changed.
5.5 Display System
Requirements 5.5.2 ~ 5.5.8 applies only to anti-muscle instrument with a display system. 5.5.2 ~ 5.5.8 Technical Specifications shall muscle anti-meter output display
The measurement part.
5.5.2 Indication accuracy
Error is less than ± 10% or ± 2μV, whichever is greater.
5.5.3 Resolution (measurement sensitivity)
≤2μV.
5.5.4 system noise
≤1μV.
5.5.5 passband
Unless otherwise noted manufacturer, muscle anti instrument should not be narrower than the pass band of 20Hz ~ 500Hz (-3dB) (not including depression wave band).
5.5.6 differential input impedance
Greater than 5MΩ.
5.5.7 CMRR
5.5.8 frequency notch filter
Anti-muscle instrument should 50Hz notch filter, after the amplitude attenuation should not exceed 5μV (peak - valley).
5.6.1 Anti-muscle meter surface should be smooth, it should be clear and accurate identification, no obvious scratches and bumps.
5.6.2 Fasteners should be connected firmly, the knob, the function switch should be installed accurately and reliably adjusted.
5.7 User's Guide
Instructions meet GB 9706.1-2007 and GB 9706.15-2008 (if applicable) at the same time, it should include at least the following
a) anti-muscle instrument technical parameters, including: the magnitude of the measuring range, the measured response feedback band center frequency specified in Table 1
b) for the reusable electrodes cleaning and disinfection methods and replacement cycle.
c) an electrode to make firm contact with the skin to provide placement, pre-treatment of the skin treatment recommendations.
d) the size of the electrode, the shape of the applicable muscles relations, placement of the electrodes and the distance placement recommendations.
e) the proposed use of the environment: sources of RF interference should be shut down or away from the source of the RF transmitter.
f) to deal with anti-muscle instrument in the instructions for use in accordance with Table 2, the feedback indicates different degree feedback response will be described separately.
For only two feedback response of the anti-muscle apparatus, brochures response no response and the initial response of both the feedback response, provide the appropriate
Feedback indicates that description.
Unless otherwise stated the manufacturer, the input signal should be tested according to the test point specified in Table 1, if necessary, these test points can be
Extended to include other characteristic parameter values manufacturers design.
Table 1 lists the test point feedback indicated
20 center frequency of FM 500
5 No response No response No response
Feedback threshold No response
Manual measuring range upper limit claimed unresponsive
Table 2 Response Status
Table 2 indicates the different response degree feedback
Description of the amplitude level feedback indicates
\u003cU0 无响应 注2
Feedback threshold Note 1
U0 initial response Note 2
UM intermediate Note 2
UH Complete Response Note 2
> UH Complete Response Note 2
U0: refers to the muscle can never respond to anti-instrument indicating the response state to the initial state of the design threshold. For only two kinds of feedback indication (ie no response
Status and response status indication) muscle anti-meter Table 1 feedback threshold allows only nominal U0.
UH: refers to the muscle allows the feedback indicates that the anti-instrument design to achieve the threshold full response status.
UM: between U0 and UH, be able to characterize an intermediate state in response to the design threshold, if necessary, include a plurality of UM values, such as UM1, UM2,
UM3.
Note 1: This standard is mentioned in the feedback threshold is ordered muscle anti-feedback indicating instrument to achieve different input amplitude response extent collectively, these thresholds are usually
Set by the manufacturer (U0, UH, UM feedback threshold are in a certain threshold) according to the center frequency.
Note 2: The feedback indicates detailed description. Feedback indication includes visual feedback (such as a table-type pointer, digital, colored cursor, curve, graphics, etc.) and auditory feedback (eg
Loudness, frequency, rhythm, pitch change, etc.). For example: When using voice instructions as EMG feedback and audible feedback instructions should be described as sound
Sound loudness, frequency, rhythm or tone index within a range specified by the manufacturer. Such as the use of graphics instructions EMG feedback, the feedback means
Should be described as shown in the graphic shapes, colors or graphics change rate index, a range of graphical rate of change should be specified by the manufacturer.
5.8 Safety Requirements
Electrical Safety muscle anti instrument shall meet the requirements of GB 9706.1-2007.
If applicable, the safety of the electrical system shall comply with the requirements of GB 9706.15-2008.
5.9 Environmental test requirements
Environmental testing muscle anti Instrument shall GB/T 14710-2009 regulations.
5.10 biocompatibility
Guide application portion of the material is expected to contact with human skin, it should be in accordance with GB/T 16886.1-2011 and principles given birth
Biocompatibility tests or assessment and documented.
5.11 Electromagnetic compatibility requirements
Anti-muscle instrument shall meet the requirements of YY 0505-2012.
6.1.1 Pretreatment
Before the test, the anti-muscle tester should test site parking is not energized at least 24h, before the official test, should press the User's Guide to
Anti muscle seek operation instrument.
6.1.2 Test Environment
See GB 9706.1-2007 requirements in 4.5.
Close or far away from sources of RF interference around.
6.1.3 Test circuit
The test circuit is connected as follows:
a) Unless otherwise stated, Figure 1 S1 is normally closed.
b) reference pole (if any) should be grounded.
c) the dotted line in Figure 1 shows the shield case is connected to the ground reference point.
R1 = 100kΩ, an accuracy of ± 0.1%;
R2 = 100Ω, an accuracy of ± 0.1%.
Common test circuit of Figure 1
6.1.4 Test Instruments
Test equipment to meet the following requirements:
a) Source: frequency error ≤2%, nonlinear distortion ≤0.1%;
b) Unless otherwise indicated, the standard test resistance in the circuit of the maximum permissible error of ± 1%, is recommended to use low-noise resistance;
c) the maximum permissible error of capacitance ± 5%;
d) test waveforms: Input voltage amplitude error does not exceed ± 2%.
Check the feedback indicated 6.2
Press muscle anti electrically connected instrument 1, the test signal source generates adjustment signals as specified in Table 1, actually measured or visually (for
Different feedback indication shall be specified by the manufacturer of different test methods), shall comply with the provisions of 5.2.
6.3 feedback detection threshold
Press the electrodes are connected anti-muscle apparatus in FIG. 1, adjust the signal source produces a sinusoidal output signal, adjust the signal frequency to the center frequency specified by the manufacturer
Adjusting the amplitude of the signal source, while observing the feedback indicates that the anti-muscle instrument, when observed feedback threshold as described in Table 1 corresponding to the feedback means
When shown, the recording signal amplitude at this time with the manufacturer's prescribed feedback threshold comparison, the error should be consistent with the provisions of 5.3.
6.4 inspection frequency noise suppression
So muscular anti Tool input amplitude reaches specified by the manufacturer of the feedback threshold U0 above, observe the anti-feedback indicates muscle instrument.
Then at the input of the anti-muscle instrument and then superimposed a magnitude of 100μV (peak - valley) of frequency sinusoidal signals, observe the muscle anti-feedback device means
It should be shown no observed changes.
Then adjust the amplitude of the signal source to the feedback threshold U0 below Repeat the previous step for inspection.
6.5 Display System
Test 6.5.1 Indication Accuracy
First signal source calibration instrument display anti-muscle system, its accuracy should meet the requirements. Then muscle anti-analyzer display, measuring other technologies
Figure 1 anti-muscle connection device electrodes.
Adjust the signal source sinusoidal AC signal is applied to the input of the anti-muscle apparatus, the signal frequency of manufacturers to design the center frequency.
Adjusting the amplitude of the signal source, test point for the specification of the file claimed maximum measuring range and 10% of the maximum (generally not less than
10μV), read the display muscle anti instrument, its accuracy should be consistent with the provisions of 5.5.2.
6.5.2 Resolution (measurement sensitivity) test
Adjust the output frequency of the signal source for the manufacturers to design the center frequency, amplitude of 10mV, continue to regulate the voltage amplitude when the amplitude of each adjustment
When 2mV, display value observe the anti-muscle instrument should be observed changes that comply with the provisions of 5.5.3.
6.5.3 Test system noise
The input of the counter-meter short muscle, muscle observed value is displayed anti instruments, namely input noise, shall comply with the provisions of 5.5.4.
6.5.4 Test passband
Adjust the signal source output sinusoidal AC signal amplitude 100.0mV, frequency of manufacturers to design the center frequency, according to Figure 1 Anti-muscle connection instrument
Displayed value recording muscle anti instrument V0, the frequency of the input signal from the center frequency to down, when the anti-muscle instrument display is 70.7μV time,
When recording the frequency value f1, and then from the center frequency to increase, when the anti-muscle instrument display as 70.7μV, record the frequency value f2, f1 ~ f2
Is the pass band (test manufacturers should avoid the trap set by the band), f1 should be less than the lower limit of the pass band, f2 shall not be less than passband
With the upper limit.
6.5.5 differential input impedance Zdi test
Anti-read instrument displays muscle is V1. Open S1, read anti-muscle instrument displayed value V2; according to equation (1) to calculate Zdi, in line with the results
Provisions 5.5.6.
Zdi =
Zdi --- differential input impedance, unit megohms (MΩ);
V1 --- S1 muscle anti-meter closed display value;
V2 --- S1 anti-muscle instrument opened display value;
R = 0.62MΩ.
The anti-muscle instrument input electrode connected interchangeably, repeat the test.
6.5.6 common mode rejection ratio CMRR test
Anti-muscle instrument should have the ability to inhibit the body surface frequency signal interference. Press the electrodes are connected anti-muscle apparatus in FIG. 2, a signal source output adjustment
Amplitudes Vin is 1V ~ 5V, 2 octave frequency of the signal frequency.
Numerical muscle anti recording instrument display is V0, according to equation (2) calculation, the results comply with the provisions of 5.5.7.
CMRR = 20lg
CMRR --- CMRR;
Vin --- signal source output value;
V0 --- muscle anti instrument display.
Figure 2 CMRR test chart
6.5.7 frequency notch filter test
Adjusting the signal source produces a signal frequency of 50Hz sine wave, then adjust the amplitude of the signal source to 100mV (peak - valley), recording muscle
Numerical solution of inverse display instrument shall comply with the provisions of 5.5.8.
6.6 Appearance
By visual inspection, it shall comply with the provisions of 5.6.
6.7 User's Guide
See manual, it shall comply with 5.7.
6.8 Safety Requirements
Safety requirements, test methods according to GB 9706.1-2007 and GB 9706.15-2008 Test conducted.
6.9 Environmental test requirements
Environmental testing muscle anti Instrument shall GB/T 14710-2009 methods and procedures for implementation of the provisions.
6.10 biocompatibility
By checking the information provided by the manufacturer or by the method GB/T 16886.1-2011 provisions for verification to verify compliance
6.11 Magnetic Compatibility
Electromagnetic compatibility requirements test according to the test method YY 0505-2012 be.
Guiding principles and key provisions of the
This standard was established EMG biofeedback instrument performance points and test methods used to verify the effectiveness of anti-muscle tester feedback, and should
To provide users with sufficient data to determine the performance of the device.
The standard that the instrument regardless of whether they have anti-muscle the ability to display EMG amplitude or waveform, should apply to this standard, this standard does not
Anti requires muscle instrument must have this display, but if you provide this functionality, it should comply with the criteria in the relevant regulations.
Conventional anti-muscle instrument YY 91095-1999 and YY/T 1095-2007 standard in terms of just the amplifier performance and indicators
Requests, and there is no indication given of feedback verification method, the revised standard of research and discussion by the drafting group considered muscle
Biofeedback instruments such equipment, the ultimate feedback to the patient feedback indicates the treatment is the key, so this standard highlighted on muscle
Anti-feedback device detection capability.
This appendix explains the reason behind some of the important criteria in terms.
A.2 This standard covers content
In the specification proposed in consideration of the main points:
a) How to test the correctness of the anti-muscle EMG instrument to produce effective responses. Effective EMG:
EMG is a weak, signals, EMG amplitude for healthy people can reach 1000μV ~ 3000μV (peak - valley),
For the magnitude of the residual limb are generally less than 350μV (peak - valley), the effective frequency range of the human skin surface electromyography to 20Hz
~ 500Hz, mainly concentrated in the frequency range of 50Hz ~ 150Hz. Therefore, the standard drafting team to develop specifications
When the view that unless the manufacturer stated otherwise above 500Hz frequency signal is invalid and should not produce the expected feedback
In response, 20Hz and below the signal as noise should be suppressed.
b) anti-muscle instrument invalid signal and noise should not respond. The main noise signal:
1) the inherent noise of the electronic device;
2) ambient noise (mainly electromagnetic radiation), when the requirements of this standard test Close or far away from sources of RF interference around, so this
Where the main consideration is the ambient noise frequency noise signal of 50Hz;
3) skin and the electrodes and cables improper placement of noise introduced, mainly in the 20Hz or less.
A.3 Performance Requirements
Unless otherwise indicated, the magnitude of this standard are referred RMS (rms). This is because the use of surface ECG electrodes collected brain
Electricity, EMG are the body's biological signals when these signals can be used to analyze the root mean square (RMS) value or peak to points
Analysis, ECG, EEG and EMG, etc. mainly used for biometric devices more waveform analysis using the method of analysis of the peak,
As EMG biofeedback device class is primarily concerned with the average level (ie muscle size quantized values) EMG, and therefore the use of
Root mean square (RMS) value for analysis will be more suitable.
A.3.2 feedback indicates
Because of the randomness great EMG, you want to detect and quantify it becomes very difficult to make the anti-muscle apparatus to work properly, you should be able to do
Correct detection of EMG useful, and can make the right response at the time reaches the set threshold.
Usually time-domain analysis and evaluation of EMG parameters have integrated EMG value (IEMG), root mean square value (RMS), the average amplitude (MA)
Etc., in the frequency domain analysis of two common indicators of analysis, that is mean power frequency (MPF) and median frequency (MF), these assessments
Characteristic parameter is the voltage amplitude and frequency. Accordingly, this method is given by the standard analog with certain characteristics (see Table 1) muscle
Electrical signal is input to detect the effectiveness of anti-muscle instrument.
Unless otherwise stated the manufacturer, such as those with special needs or in response to specific feedback for muscle tissue is not necessary to set the frequency 20Hz ~
Within the 500Hz range specified by the manufacturer prior test frequency.
Specified in Table 1 of the center frequency of the FM: refers to muscle tissue according to the manufacturer (or muscle group) targeted set of characteristic frequency.
Feedback response frequency (FL ~ FH) and the center frequency of the FM Figure A.1.
Frequency domain analysis of EMG Figure A.1
Specified in Table 1 of the amplitude of the input 5μV out of consideration for the input noise, because the standards set forth in the value of the system noise is allowed
1μV, allowing frequency noise attenuated amplitude of 5μV (peak - valley), consider the input noise values of both the worst case is not superimposed
In 5μV (rms), so this provision made using the amplitude of the input signal to detect muscle 5μV anti Instrument unresponsive.
When they enter the specification limit on claiming simulation measurement range, if the anti-muscle apparatus in response to feedback band can make the right response
Should be, then this muscle anti-instrument measurement capabilities to achieve the specification of the stated value.
Accuracy A.3.3 feedback threshold
The standard mentioned feedback threshold is characterizing enables the instrument to achieve muscle anti input amplitude of a feedback response. Standard assessment only
Set in the center frequency of the FM under the threshold by the manufacturer. Table 2 Note 1 may be mentioned that the present standard feedback threshold may not only for a
Months, if the design for multiple feedback threshold, they should test the accuracy of each.
A.3.4 frequency noise suppression
Anti muscle meter should be able to suppress the noise detection circuit vast majority of clinical use that may be encountered, 100μV (peak - valley) of the positive frequency
Sinusoidal signal amplitude is provided by YY 1079 in.
In addition to power-frequency noise and other random noise amplitude generally less than frequency noise, the proper use of the electrode can be eliminated. When this test frequency
Notch filter should be in working condition.
A.3.5 Display System
As the standard for anti-muscle apparatus is not used to diagnose the disease, so this standard for anti-muscle instrument display accuracy requirements may not
As harsh as diagnostic use class equipment, nor t......
Related standard: YY/T 1306-2016