YY 0780: Evolution and historical versions
| Standard ID | Contents [version] | USD | STEP2 | [PDF] delivered in | Standard Title (Description) | Status | PDF |
| YY 0780-2025 | English | RFQ |
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3 days [Need to translate]
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(Traditional Chinese Medicine Equipment - Electroacupuncture therapy device)
| Valid |
YY 0780-2025
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| YY 0780-2018 | English | 199 |
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Electroacupuncture therapy device
| Valid |
YY 0780-2018
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| YY 0780-2010 | English | 399 |
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3 days [Need to translate]
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Electroacupuncture therapy device
| Obsolete |
YY 0780-2010
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Basic data | Standard ID | YY 0780-2025 (YY0780-2025) | | Description (Translated English) | (Traditional Chinese Medicine Equipment - Electroacupuncture therapy device) | | Sector / Industry | Medical Device & Pharmaceutical Industry Standard | | Classification of Chinese Standard | G42 | | Classification of International Standard | 11.040.60 | | Date of Issue | 2025-06-18 | | Date of Implementation | 2028-07-01 | | Older Standard (superseded by this standard) | YY 0780-2018 | | Issuing agency(ies) | National Medical Products Administration | YY 0780-2018: Electroacupuncture therapy device---This is a DRAFT version for illustration, not a final translation. Full copy of true-PDF in English version (including equations, symbols, images, flow-chart, tables, and figures etc.) will be manually/carefully translated upon your order.
Electroacupuncture therapy device
ICS 11.040.60
C42
People's Republic of China Pharmaceutical Industry Standard
Replacing YY 0780-2010
Electroacupuncture treatment instrument
Published on.2018-06-26
2019-07-01 implementation
State Drug Administration issued
Content
Foreword I
1 Scope 1
2 Normative references 1
3 Terms and Definitions 1
4 Requirements 2
5 Test method 4
Foreword
The full technical content of this standard is mandatory.
This standard was drafted in accordance with the rules given in GB/T 1.1-2009.
This standard replaces YY 0780-2010 "Electric Needle Therapy Apparatus". Compared with YY 0780-2010, the main technical changes except editorial changes
The following is as follows.
--- Revised the definition of electroacupuncture treatment instrument and electroacupuncture (see 3.1, 3.2, 3.1, 3.3 of.2010 edition);
--- Added the definition of electrode needle, electrode pin connector, electrode line, output terminal, output channel (see 3.3~3.7);
---Modified the pulse energy requirements and test methods (see 4.2.3, 5.2.1,.2010 edition of 4.7.2.4 line 4, 5.7);
--- Increased requirements for output channel independent control, channel interference, output channel identification, output short circuit and open circuit protection and test
Test method (see 4.4~4.7, 5.4~5.7);
--- Modified the requirements and test methods for the electrode needle (see 4.8, 5.8, 4.5, 5.5 of the.2010 edition);
--- Increased requirements and test methods for electrode pin connectors and electrode wires (see 4.9, 5.9);
--- Increased requirements for external marking of equipment or equipment components (see 4.10.2.1);
--- Revised the requirements for the accuracy of random files and work data (see 4.10.2.2, 4.10.2.3, 4.7.2.1, 4.7.2.2 of the.2010 edition);
---Modified the requirements for electromagnetic compatibility (see 4.11, 4.7.3 of the.2010 edition);
--- Modified the test method of DC component (see 5.2.2, 5.2 of.2010 edition);
--- Removed the definition of application part, load impedance, pulse width, output waveform, and operating frequency (2010, 3.2, 3.4~3.7).
Please note that some of the contents of this document may involve patents. The issuing organization of this document is not responsible for identifying these patents.
This standard was proposed by the State Drug Administration.
This standard is under the jurisdiction of the National Medical Electrical Equipment Standardization Technical Committee Physical Therapy Equipment Subcommittee (SAC/TC10/SC4).
This standard was drafted. Tianjin Medical Device Quality Supervision and Inspection Center, Shanghai Daosheng Medical Technology Co., Ltd., Chengdu Huaxin Hi-Tech
Medical Devices LLC.
The main drafters of this standard. Zhang Wei, Qi Lijing, Zhang Haiming, Qian Xuebo, Zhou Huilin, Chen Xinyun.
The previous versions of the standards replaced by this standard are.
---YY 0780-2010.
Electroacupuncture treatment instrument
1 Scope
This standard specifies the terms and definitions, requirements and test methods of electroacupuncture treatment instruments (hereinafter referred to as therapeutic instruments).
This standard applies to instruments that are treated and assisted by electroacupuncture.
2 Normative references
The following documents are indispensable for the application of this document. For dated references, only dated versions apply to this article.
Pieces. For undated references, the latest edition (including all amendments) applies to this document.
GB 2024 acupuncture needle
GB 9706.1-2007 Medical electrical equipment - Part 1. General requirements for safety
GB/T 14710 Medical electrical requirements and test methods
GB/T 16886.1 Biological evaluation of medical devices - Part 1. Evaluation and testing in the process of risk management
YY 0505 Medical Electrical Equipment - Part 1-2. Safety General Requirements Parallel Standards. Electromagnetic Compatibility Requirements and Testing
YY 0607-2007 Medical electrical equipment - Part 2. Particular requirements for safety of nerve and muscle stimulators
YY/T 0696-2008 Measurement of output characteristics of nerve and muscle stimulators
3 Terms and definitions
The following terms and definitions defined in YY 0607-2007 apply to this document.
3.1
An instrument for the treatment and adjuvant treatment of patients by electroacupuncture. Usually includes a host, electrode wire and electrode pin connectors, and can also include
Set of electrode pins used.
3.2
Electroacupuncture electroacupuncture
A therapy, that is, after acupuncture into the muscle tissue to obtain a sense of acupuncture, a small amount of current is applied to the needle, and a double stimulation of acupuncture and electricity is used to assist the treatment of the disease.
a method of illness.
3.3
Electrode needle electroacupunctureneedle
The acupuncture needle for the electroacupuncture treatment device can be connected to the electrode needle connector to conduct the current output from the therapeutic device to the muscle tissue.
3.4
Electrode needle connector electroacupunctureneedleclamp
A device for connecting an electrode wire to an electrode needle, the type of which includes, but is not limited to, a clip type.
3.5
Electrode line electroacupunctureneedleconnector
Connect the electrode pin connector to the lead of the output terminal to deliver the output current of the therapy device. Can be composed of multiple segments, including
Connector.
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