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YY/T 1095-2015Myoelectric biofeedback equipment (English PDF)

肌电生物反馈仪

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Issued by

NMPA

Level / Type

Industry · Recommended

Issue date

March 2, 2015

Implementation date

January 1, 2016

Scope

YY/T 1095-2015 is the English-translated version of 肌电生物反馈仪.

YY/T 1095-2015 is the Chinese pharmaceutical industry standard for myoelectric biofeedback equipment, the device that records the electromyogram and feeds it back to the patient as a signal to be trained on.

It specifies the terms and definitions, the classification, the requirements and the test methods, covering the input impedance, the noise and the frequency response of the amplifier, the accuracy with which the signal is measured, the feedback given to the patient, the electrodes and the electrical safety. Issued on 2 March 2015, it has applied since 1 January 2016.

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Document preview — YY/T 1095-2015

National Standard of the People's Republic of China

Replacing: YY/T 1095-2007

Issued by: National Medical Products Administration of the People's Republic of China

Foreword3
1 Scope5
2 Normative References5
3 Terms and Definitions5
4 Classification6
5 Requirements6
6 Test Methods10
Appendix A (Informative) Guideline and Principle of Important Clauses16
Bibliography21

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);

--- Add the guideline and principle of important clauses in the informative appendix (see Appendix A).

Please note some contents of this document may involve patents. The issuing agency of this document assumes no responsibility to identify these patents.

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 document.

3.1 Myoelectric biofeedback equipment

The instrument that uses surface electrode to collect the body myoelectric signal as the physiological information, which gives feedback to patients in visual or acoustical forms;

3.2 Surface electrode

The electrode that is placed on the skin surface (or cavity surface), and to be used for collecting myoelectric signal to conduct the non-invasive detection.

3.4 Feedback response frequency bands

The frequency range that can achieve the expected feedback response.

3.5 Feedback threshold

The amplitude when different response degree is achieved.

4 Classification

It can be divided into the myoelectric biofeedback equipment with and without display system as per the structure.

5 Requirements

5.6 Appearance

5.1 Working conditions

It shall conform to the manufacturer's provisions; if there are no provisions, it shall conform to the requirements in Chapter 10 of GB 9706.1-2007.

5.3 Accuracy of feedback threshold

The feedback threshold shall be specified by the manufacturer, and shall not be greater than ±10% of the nominal value measured at the center frequency point.

5.5 Display system

5.5.1 Overview

The requirements in 5.5.2~5.5.8 are only applicable to the myoelectric biofeedback equipment with display system. The technical indicators in 5.5.2~5.5.8 shall be measured from the output display part of the myoelectric biofeedback equipment.

5.5.6 Differential-mode input impedance

Greater than 5Mohm.

5.5.7 Common-mode rejection ratio

Greater than 100dB.

5.5.8 Power-frequency notch filter

Myoelectric biofeedback equipment shall be equipped with 50Hz notch filter, attenuation-post amplitude shall be no greater than 5µV (Peak-Valley Value).

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. […]

5.8 Safety requirements

The electric safety of myoelectric biofeedback equipment shall meet the requirements of GB 9706.1-2007.

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.

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.

6.1.3 Test circuit

The connection method of test circuit shall be shown as follows. […]

6.1.4 Test instrument

The test instrument shall meet the following requirements. […]

6.2 Inspection of feedback indication

Connect the electrodes of the myoelectric biofeedback equipment as per the Figure 1; adjust the signal source to generate the test signal stipulated in Table 1;

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.

6.6 Appearance

Inspect through the visual observation, which shall conform to the provision of 5.6.

6.7 Instruction manual

Check the instruction manual, which shall conform to the provision of 5.7.

6.8 Safety requirements

Safety requirement test shall be performed as per the test methods stipulated in GB 9706.1-2007 and GB 9706.15-2008.

6.9 Environmental test requirements

The environmental test of myoelectric biofeedback equipment shall be performed as per the methods and procedures stipulated in GB/T 14710-2009.

6.10 Biocompatibility

Compliance is checked through inspecting the materials provided by the manufacturer, or through verification as per the method stipulated in GB/T 16886.1-2011. […]

......
This preview omits tables, figures, formulas and parts of the technical clauses. The complete document — 21 pages — is available in the English PDF.

Referenced standards

Normative references

Editions of YY/T 1095

Edition	Title	Revision	Status
YY/T 1095-2015	Myoelectric biofeedback equipment	current edition	Current
YY/T 1095-2007	Myoelectric biofeedback equipment	previous edition	Superseded

This page sells the current edition, YY/T 1095-2015. Earlier editions are listed for reference only.

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