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YY/T 1095-2015

Chinese Standard: 'YY/T 1095-2015'
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Detail Information of YY/T 1095-2015; YY/T1095-2015
Description (Translated English): Myoelectric biofeedback equipment
Sector / Industry: Medical Device & Pharmaceutical Industry Standard (Recommended)
Classification of Chinese Standard: C42
Classification of International Standard: 11.040.60
Word Count Estimation: 13,193
Date of Issue: 2015-03-02
Date of Implementation: 2016-01-01
Older Standard (superseded by this standard): YY/T 1095-2007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
Regulation (derived from): The State Food and Drug Administration Announcement 2015 No. 8
Proposing organization: China Food and Drug Administration
Issuing agency(ies): China Food and Drug Administration
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.

YY/T1095-2015
YY
PHARMACEUTICALS INDUSTRY STANDARD
OF THE PEOPLE’S REPUBLIC OF CHINA
ICS 11.040.60
C 42
Replacing YY/T 1095-2007
Myoelectric Biofeedback Equipment
肌电生物反馈仪
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
Foreword
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
1 Scope
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
Electrical Equipment
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.
5.10 Biocompatibility
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
6.1.1 Pre-treatment
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 ......
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