YY 0903-2013_English: PDF (YY0903-2013)
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Electroencephalographic biofeedback equipment
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YY 0903-2013
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Standards related to: YY 0903-2013
| Standard ID | YY 0903-2013 (YY0903-2013) | | Description (Translated English) | Electroencephalographic biofeedback equipment | | Sector / Industry | Medical Device & Pharmaceutical Industry Standard | | Classification of Chinese Standard | C42 | | Classification of International Standard | 11.040.60 | | Word Count Estimation | 12,112 | | Quoted Standard | GB/T 191; GB 9706.1-2007; GB 9706.15; GB/T 14710; GB/T 16886.1; GB/T 16886.5-2003; GB/T 16886.10-2005; YY/T 0466.1; YY 0505; YY/T 0708; JJG 954-2000 | | Drafting Organization | State Food and Drug Administration, Tianjin Medical Device Quality Supervision and Inspection Center | | Administrative Organization | National Medical Electrical Equipment Standardization Technical Committee Physiotherapy Technical Committee for Standardization | | Regulation (derived from) | State Food and Drug Administration Notice No. 36 of 2013; industry standard for filing Notice 2013 No. 12 (No. 168 overall) | | Proposing organization | State Food and Drug Administration | | Issuing agency(ies) | State Food and Drug Administration | | Summary | This standard specifies the definition of EEG biofeedback instrument, classification and composition requirements, test methods, inspection rules, marking, packaging, transportation and storage. This standard applies to EEG biofeedback instrument (hereina | YY 0903-2013
YY
PHARMACEUTICAL STANDARD
OF THE PEOPLE’S REPUBLIC OF CHINA
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
YY 0505 Medical Electrical Equipment – Part 1-2. General Requirements for
Safety – Collateral Standard. Electromagnetic Compatibility – Requirements and
Tests
YY/T 0708 Medical Electrical Equipment – Part 1-4. General Requirements for
Safety – Collateral Standard. Programmable Electrical Medical Systems
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.
5.2.8 Notch filter
There shall be a 50Hz notch filter, and the amplitude value after attenuation does not
be greater than 5μV (peak-to-valley value).
5.2.9 Time interval
The error does not exceed ±5%.
5.2.10 Input impedance
Not less than 5 MΩ.
5.2.11 Biocompatibility of EEG Electrodes
The equipment parts and accessories which are expected to come in contact with the
skin of the patient shall be evaluated and documented in accordance with the
guidelines and principles given in GB/T 16886.1.
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
5.5.1 The manufacturer shall develop the appropriate technical requirements in
accordance with the functions of the electroencephalographic biofeedback equipment.
5.5.2 They shall meet the requirements of YY 0708.
5.6 Appearance
The surface of the electroencephalographic biofeedback equipment shall be smooth
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
6.5.1 The test shall be conducted in accordance with the method specified by the
manufacturer and shall meet the requirements of 5.5.1.
6.5.2 The test shall be conducted in accordance with the method specified in YY
0708 and shall meet the requirements of 5.5.2.
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.
6.8 Electromagnetic compatibility test
The test shall be conducted in accordance with the method specified in YY 0505 and
shall meet the requirements of 5.8.
6.9 Environmental test
The test shall be conducted in accordance with the method specified in GB/T 14710
and shall meet the requirements of 5.9.
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.
repair and safety precautions.
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.
9.1.2 The equipment shall be provided with the measures in the packing case such
as rainproof, dampproof and soft padding.
9.1.3 The equipment shall be fixed securely in the packing case so as to prevent
loosening or scratches during transportation.
9.1.4 The equipment can be transported in nude packing in accordance with the
purchase contract; in case of nude packing, protective measures shall be taken during
the transportation process; and the specific requirements shall be as specified by the
purchase contract.
9.1.5 The equipment shall be accompanied by the following documents.
a) a product inspection qualification certificate;
b) a product instruction manual;
d) a packing list; and
d) a product service card.
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.
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