YY/T 1095-2015 English PDF (YYT1095-2015)
YY/T 1095-2015 English PDF (YYT1095-2015)
YY/T 1095-2015: Myoelectric biofeedback equipment
PHARMACEUTICALS INDUSTRY STANDARD
OF THE PEOPLE’S REPUBLIC OF CHINA
Replacing YY/T 1095-2007
Myoelectric Biofeedback Equipment
ISSUED ON. MARCH 2, 2015
IMPLEMENTED ON. JANUARY 1, 2016
Issued by. China Food and Drug Administration
Table of Contents
Foreword ... 3
1 Scope ... 5
2 Normative References ... 5
3 Terms and Definitions ... 5
4 Classification ... 6
5 Requirements ... 6
6 Test Methods ... 10
Appendix A (Informative) Guideline and Principle of Important Clauses ... 16 Bibliography ... 21
This Standard was drafted as per the rules specified in GB/T 1.1-2009.
This Standard’s safety requirements fully implement the contents of 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. This Standard replaces YY/T 1095-2007 Myoelectric Biofeedback Equipment. Compared with YY/T 1095-2007, this Standard mainly has the following technical differences.
--- Modify this Standard’s applicable scope (see Chapter 1);
--- Add the classification (see Chapter 4);
--- Modify the requirements for feedback instructions and test methods (see 5.2, 6.2 of this edition; 4.2.7, 5.2 of 2007 edition);
--- Add the requirements for feedback thresholds and test methods (see 5.3, 6.3); --- Add the requirements for suppression of power-frequency noise and test methods (see 5.4, 6.3);
--- Delete the requirements for original measuring range and test methods (see 4.2.1, 5.3.1 of 2007 edition);
--- Add the requirements for the accuracy of indicating value and test methods (see 5.5.2, 6.5.1);
--- Delete the requirements for original sensitivity (see 4.2.8 of 2007 edition); --- Add the requirements for resolution and test methods (see 5.5.3, 6.5.2); --- Modify the requirements for passband and test methods (see 5.5.5, 6.5.4 of this edition; and 4.2.4, 5.3.4 of 2007 edition);
--- Add the requirements for power-frequency notch filter and test methods (see 5.5.8, 6.5.7);
--- Delete the requirements for original isolation (see 4.2.9 of 2007 edition); --- Add the safety requirements (see 5.8);
--- Add the contents and requirements for instruction manual (see 5.7); Myoelectric Biofeedback Equipment
This Standard specifies the terms and definitions, classification, requirements, test methods of myoelectric biofeedback equipment (hereinafter referred to as the myoelectric biofeedback equipment).
This Standard is applicable to the myoelectric biofeedback equipment stipulated in 3.1. This Standard is not applicable to the equipment using needle electrode to record the myoelectric signal, and myoelectric evoked potential equipment.
2 Normative References
The following documents are essential to the application of this document. For the dated documents, only the versions with the dates indicated are applicable to this document; for the undated documents, only the latest version (including all the amendments) are applicable to this document.
GB 9706.1-2007 Medical Electrical Equipment - Part 1. General Requirements for Safety
GB 9706.15-2008 Medical Electrical Equipment - Part 1-1. General Requirements for Safety - Collateral Standard. Safety Requirements for Medical Electrical Systems
GB/T 14710-2009 Environmental Requirement and Test Methods for Medical
GB/T 16886.1-2011 Biological Evaluation of Medical Devices - Part 1. Evaluation and Testing within a Risk Management Process
YY 0505-2012 Medical Electrical Equipment - Part 1-2. General Requirements for Safety - Collateral Standards. Electromagnetic Compatibility - Requirements and Tests
3 Terms and Definitions
The following terms and definitions defined in GB 9706.1-2007 are applicable to this 5.6.1 The myoelectric biofeedback equipment surface shall be smooth, its mark shall be clear and accurate without obvious scratches or damages.
5.6.2 Fastener shall be connected tightly, function switch shall be installed accurately, adjustment shall be reliable.
5.7 Instruction manual
The instruction manual shall meet the requirements of GB 9706.1-2007 and GB 9706.15-2008 (if applicable); meanwhile it shall also include at least the following contents.
a) Technical parameters of myoelectric biofeedback equipment include
measuring range of amplitude, feedback response frequency band, center
frequency and the test points stipulated in Table 1.
b) Cleaning and disinfecting methods, and replacing cycle for the reusable electrode.
c) Provide a method for placing the electrode in firm contact with the skin; advise how to treat the skin before treatment.
d) The relationship between electrode size, shape and applicable muscle; the advice on the position and distance of placing electrode.
e) Recommended use environment. the radio frequency interference source shall be switched off, or keep away from the radio frequency emission source. f) In the instruction manual, the feedback indication of myoelectric biofeedback equipment shall be described as per the different feedback response degree stipulated in Table 2.
For the myoelectric biofeedback equipment with only two feedback responses, the instruction manual shall provide corresponding feedback indication
description against the two feedback responses, namely, no response and initial response.
Unless otherwise is specified by the manufacturer, the input signal shall be tested in accordance with the test points specified in Table 1; if necessary, these test points can be expanded, so that contain other characteristic parameter values designed by the manufacturer.
If applicable, the electric safety of the system shall meet the requirements of GB 9706.15-2008.
5.9 Environmental test requirements
The environmental test of the myoelectric biofeedback equipment shall be performed as per the provisions of GB/T 14710-2009.
Materials intended to use in contact with the human skin shall conduct the biocompatibility test or evaluation, and form document according to the guideline and principle stipulated in GB/T 16886.1-2011.
5.11 Electromagnetic compatibility requirements
Myoelectric biofeedback equipment shall meet the requirements of YY 0505-2012. 6 Test Methods
6.1 Working conditions
Before test, the myoelectric biofeedback equipment shall be parked on the test site for at least 24h without being energized; before the official test, the myoelectric biofeedback equipment shall be run as per the requirements of the instruction manual. 6.1.2 Test environment
See the requirement of 4.5 in GB 9706.1-2007.
Switch off or keep away from the surrounding radio frequency interference source. 6.1.3 Test circuit
The connection method of test circuit shall be shown as follows.
a) Unless otherwise specified, S1 in Figure 1 shall be normally closed. b) The reference electrode (if any) shall be grounded.
c) The dashed line in Figure 1 represents shielding case, and reference point connecting to the earth.
corresponding to the feedback threshold described in Table 1, record the signal amplitude at this time, and compare which with the feedback threshold stipulated by the manufacturer; the error shall conform to the provision of 5.3.
6.4 Inspection of power-frequency noise suppression
Connect the electrodes of the myoelectric biofeedback equipment as per the Figure 1; adjust the signal source to generate the sinusoidal signal output; adjust the signal frequency to reach the center frequency value stipulated by the manufacturer. Make the amplitude on the input end of the myoelectric biofeedback equipment reach above the feedback threshold U0 stipulated by the manufacturer; then observe the feedback indication of the myoelectric biofeedback equipment.
Then superimpose the power-frequency sinusoidal signal with amplitude 100µV (Peak- Valley Value) on the input end of myoelectric biofeedback equipment; observe the feedback indication of myoelectric biofeedback equipment, there shall be no observable change.
Then adjust the amplitude of the signal source to be below feedback threshold U0, and repeat the above procedure to inspect.
6.5 Display system
6.5.1 Test for the accuracy of indicating value
Firstly, use the signal source to check the display system of the myoelectric biofeedback equipment, its accuracy shall conform to the requirements. The use the display of myoelectric biofeedback equipment to measure other technical indicators. Connect the electrodes of myoelectric biofeedback equipment as per the Figure 1. Adjust the signal source, add the sinusoidal AC signal to the input end of the myoelectric biofeedback equipment; the signal frequency is the median frequency designed by the manufacturer.
Adjust the amplitude of signal source, the test point shall be the maximum value or 10% maximum value (generally no less than 10µV) ...