YY 0903-2013 PDF English
US$150.00 · In stock · Download in 9 secondsYY 0903-2013: Electroencephalographic biofeedback equipment Delivery: 9 seconds. True-PDF full-copy in English & invoice will be downloaded + auto-delivered via email. See step-by-step procedureStatus: Obsolete
| Standard ID | Contents [version] | USD | STEP2 | [PDF] delivery | Name of Chinese Standard | Status |
| YY 0903-2013 | English | 150 |
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Electroencephalographic biofeedback equipment
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YY 0903-2013: Electroencephalographic biofeedback equipment---This is an excerpt. Full copy of true-PDF in English version (including equations, symbols, images, flow-chart, tables, and figures etc.), auto-downloaded/delivered in 9 seconds, can be purchased online: https://www.ChineseStandard.net/PDF.aspx/YY0903-2013
YY
PHARMACEUTICAL STANDARD
ICS 11.040.60
C 42
Electroencephalographic Biofeedback Equipment
Issued on. OCTOBER 21, 2013
Implemented on. OCTOBER 1, 2014
Issued by. China Food and Drug Administration
Table of Contents
Foreword... 3
1 Scope... 4
2 Normative References... 4
3 Terms and Definitions... 5
4 Classification and Composition... 6
5 Requirements... 6
6 Test Method... 8
7 Inspection Rules... 13
8 Marking and Instruction Manual... 14
9 Packaging, transportation and storage... 16
Foreword
If the materials or structures of the equipment or components are different from those
specified in this Standard, they should be approved only if it can be certified that they
meet equivalent specifications.
Please be noted that some content of this document may involve patents. The issuer
of this document is not responsible for identifying such patents.
This Standard was drafted according to the rules given in GB/T 1.1-2009.
This Standard was proposed by China Food and Drug Administration.
This Standard shall be under the jurisdiction of the Technical Subcommittee of Physical
Therapy Equipment of the National Technical Committee for Standardization of
Medical Electrical Equipment (SAC/TC 10/SC 4).
The main drafting organization of this Standard. China Food and Drug Administration
Tianjin Medical Devices Quality Supervision and Testing Center and Guangzhou
Rainjet Medical Devices Co., Ltd.
The main drafters of this Standard. Liu Hui, Sun Huili, Ji Caiyan, Hu Zhiwei and Yang
Jie.
Electroencephalographic Biofeedback Equipment
1 Scope
This Standard specifies the definitions, classification and composition, requirements,
test methods, inspection rules, marking, packaging, packaging and transportation.
This Standard applies to the electroencephalographic biofeedback 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 standard.
GB/T 191 Packaging – Pictorial Marking for Handling of Goods
GB 9706.1-2007 Medical Electrical Equipment – Part 1.General Requirements
for Safety
GB 9706.15 Medical Electrical Equipment – Part 1.General Requirements for
Safety – 1.Collateral Standard. Safety Requirements for Medical Electrical Systems
GB/T 14710 Environmental Requirements and Test Methods for Medical Electrical
Equipment
GB/T 16886.1 Biological Evaluation of Medical Devices – Part 1.Guidance on
Selection of Tests
GB/T 16886.5-2003 Biological Evaluation of Medical Devices – Part 5.Test for in
Vitro Cytotoxicity
GB/T 16886.10 Biological Evaluation of Medical Devices – Part 10.Tests for
Irritation and Delayed-type Hypersensitivity
YY/T 0466.1 Medical Devices - Symbols to Be Used with Medical Device Labels,
Labelling and Information to Be Supplied – Part 1.General Requirements
3 Terms and Definitions
For the purpose of this Standard, the following terms and definitions apply.
3.1 Electroencepha logram biofeedback equipment
It refers to an apparatus that uses audio-visual information to irritate and stimulate the
patients to generate brainwave information and generates new audio-visual
information to stimulate the patients based on the brainwave information, and so on,
so as to adjust and improve the cerebral functions of the patients’ brain and achieve
the purpose of adjuvant therapy.
3.2 Peak-to-valley; p-v
It refers to the amplitude of a waveform (such as a sinusoidal wave) that is measured
from above the top of the positive spike to the above of the bottom of its negative spike,
so as to eliminate the trace width.
3.5 Input impedance
It refers to the ratio of the voltage to the current phasor of any frequency signal that is
applied to the input of the amplifier.
3.6 Polarizing voltage
It refers to a specific DC voltage applied to an amplifier to check the amplifier's input
dynamic range.
3.7 Amplitude-frequency characteristics
It refers to the relationship between the amplification factor and the frequency in an
amplifier.
4 Classification and Composition
4.1 Classification
It is divided into single-channel electroencephalographic biofeedback equipment and
multichannel electroencephalographic biofeedback equipment in accordance with the
number of acquisition channels.
5 Requirements
5.1 Operating conditions
The operating conditions of the equipment shall be specified by the manufacturer and,
if not specified, shall meet the requirements of Chapter 10 of GB 9706.1-2007.
5.2 Requirements for the EEG signal acquisition part
5.2.1 Voltage measurement
The voltage measurement error shall not exceed ±10%.
5.2.6 High-pass filter
Depending on the frequency of the input signal, the manufacturer's specified high-pass
cut-off frequency can be set and the signal at the cut-off frequency is attenuated by at
least 3 dB.
5.2.7 Low-pass filter
Depending on the frequency of the input signal, the manufacturer's specified low-pass
cut-off frequency can be set and the signal at the cut-off frequency is attenuated by at
least 3 dB.
5.2.10 Input impedance
Not less than 5 MΩ.
5.3 Requirements for the audio-visual stimulation part
The manufacturer shall develop the appropriate technical requirements in accordance
with the working principle of the audio-visual stimulation part.
5.4 Requirements for the feedback
The manufacturer shall develop the appropriate technical requirements for the
feedback triggering conditions and triggering forms in accordance with the feedback
principle of the electroencephalographic biofeedback equipment.
5.5 Requirements for the software
5.6 Appearance
The surface of the electroencephalographic biofeedback equipment shall be smooth
and clean without visible damages, the colour uniform, the marking legible, the
operating mechanism (if any) flexible and all fasteners (if any) without becoming loose.
5.9 Requirements for the environmental test
The environmental test of the electroencephalographic biofeedback equipment shall
be conducted in accordance with the groups specified by the manufacturer and meet
the requirements of GB/T 14710.
6 Test Method
6.1 Test condition
6.1.1 Pretreatment
Before test, the electroencephalographic biofeedback equipment is placed in the test
location for at least 24 h without energizing, and then is operated in accordance with
the requirements of the operating instructions.
6.2 Performance test
6.2.1 Voltage measurement
The voltage measurement error of 20 μV, 50 μV, 100 μV and 200 μV shall be tested
respectively in accordance with the method specified in 5.2.4 of JJG 954-2000.The
test results shall meet the requirements of 5.2.1.
6.2.4 Amplitude-frequency characteristic
6.2.5 Polarization resistance voltage
It shall be tested in accordance with the method specified in 5.2.12 of JJG 954-2000
and the test results shall meet the requirements of 5.2.5.
6.2.8 Notch filter
Turn on the notch filter of the electroencephalographic biofeedback equipment, input
the sinusoidal wave 50 Hz 100 μV (peak-to-valley) signal to the input terminal of any
channel and check the signal amplitude which shall be attenuated to not more than 5
μV (peak-to-valley).
6.2.9 Time interval
It shall be tested in accordance with the method specified in 5.2.5 of JJG 954-2000;
and the results shall meet the requirements of 5.2.9.
6.2.10 Input impedance
6.3 Requirements for the audio-visual stimulation part
The test shall be conducted in accordance with the method specified by the
manufacturer and shall meet the requirements of 5.3.
6.4 Requirements for the feedback
The test shall be conducted in accordance with the method specified by the
manufacturer and shall meet the requirements of 5.4.
6.5 Requirements for the software
6.6 Appearance
Use eyes to observe the appearance and use hands to feel the surface. The results
shall meet the requirements of 5.7.
6.7 Safety test
The test shall be conducted in accordance with the method specified in GB 9706.1-
2007 and shall meet the requirements of 5.7.
7 Inspection Rules
7.1 Categories of inspection
The quality inspection of the equipment can be divided into exit-factory inspection and
type inspection.
7.2 Exit-factory inspection
7.2.1 The equipment to be delivered shall be inspected by the quality inspection
department of the manufacturer piece by piece before it is delivered to the customer.
Refer to Table 1 for the inspection items.
7.3 Type inspection
7.3.1 A type inspection shall be carried out in one of the following circumstances.
7.3.2 Determination of type inspection. a type inspection is determined to be a pass
if all the inspection items are qualified; or else, it is determined to be a fail.
8 Marking and Instruction Manual
8.1 Marking
8.1.1 Nameplate
A nameplate shall be provided at an appropriate location of the equipment and the
nameplate shall include at least the following information.
8.1.2 Marking on the outer packing.
8.1.3 Marking on the certificate of conformity
The certificate of conformity of a product shall be provided with at least the following
information.
8.1.4 Labeling, marking and symbols providing information
They shall meet the requirements of YY/T 0466.1.
8.2 Instruction manual
An instruction manual shall include at least the following content.
9 Packaging, transportation and storage
9.1 Packaging
9.1.1 The equipment shall be packed separately; the outer packing shall prevent the
product from natural damages; and the packing materials shall be as specified in the
purchase order.
9.1.5 The equipment shall be accompanied by the following documents.
9.2 Transportation
The requirements for transportation shall be as specified by the purchase contract.
9.3 Storage
The equipment shall be stored in a well-ventilated room, at the temperature -40°C ~
50°C and the relative humidity not exceeding 90%, where there is no corrosive gas.
......
Source: Above contents are excerpted from the full-copy PDF -- translated/reviewed by: www.ChineseStandard.net / Wayne Zheng et al.
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