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YY 0780-2025: Traditional Chinese medical device - Electroacupuncture therapy device
Status: Valid
YY 0780: Evolution and historical versions
| Std ID | Contents [version] | USD | STEP2 | [PDF] delivered in | Standard Title (Description) | Status |
| YY 0780-2025 | English | 279 |
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Traditional Chinese medical device - Electroacupuncture therapy device
| Valid |
| YY 0780-2018 | English | 199 |
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Electroacupuncture therapy device
| Valid |
| YY 0780-2010 | English | 399 |
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Electroacupuncture therapy device
| Obsolete |
Standard similar to YY 0780-2025
MT/T 914 | MT/T 668 | GB/T 1171 | Basic data
| Standard ID | YY 0780-2025 (YY0780-2025) |
| Description (Translated English) | Traditional Chinese medical device - Electroacupuncture therapy device |
| Sector / Industry | Medical Device & Pharmaceutical Industry Standard |
| Classification of Chinese Standard | G42 |
| Classification of International Standard | 11.040.60 |
| Word Count Estimation | 14,118 |
| 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| Older Standard (superseded by this standard) | YY 0780-2018 |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 |
| Summary | This standard specifies the requirements for electroacupuncture therapy instruments and describes the corresponding test methods. This document applies to instruments used for treatment and adjunctive therapy of patients via electroacupuncture. |
YY 0780-2025: Traditional Chinese medical device - Electroacupuncture therapy device
---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/YY0780-2025
ICS 11.040.60
CCSG42
Pharmaceutical Industry Standards of the People's Republic of China
Replaces YY 0780-2018
Traditional Chinese Medicine Electroacupuncture Therapy Instrument
Published on 2025-06-18
Implemented on 2028-07-01
National Medical Products Administration issued
Table of Contents
Preface III
Introduction IV
1.Scope 1
2 Normative References 1
3.Terms and Definitions 1
4 Requirements 2
5.Test Methods 4
Foreword
This document complies with the provisions of GB/T 1.1-2020 "Standardization Work Guidelines Part 1.Structure and Drafting Rules of Standardization Documents".
Drafting.
This document replaces YY 0780-2018 "Electroacupuncture Therapy Instrument". Compared with YY 0780-2018, the only changes are structural adjustments and editorial modifications.
In addition, the main technological changes are as follows.
---The requirements and test methods for output short-circuit and open-circuit protection have been changed (see 4.7, 5.7, and 4.7 and 5.7 in the.2018 version);
---The requirements and test methods for the biocompatibility of electrode needles have been removed (see 4.8.2 and 5.8.2 in the.2018 version);
---The requirements and test methods for electrode pin connectors and electrode wires have been changed (see 4.9, 5.9, and 4.9 and 5.9 in the.2018 edition);
---The requirements for external markings on the device have been changed (see 4.10.2.1, version 4.10.2.1 of.2018);
---Electromagnetic compatibility requirements and test methods have been removed (see 4.11 and 5.11 in the.2018 edition);
---The test method for the DC component has been changed (see 5.2.2,.2018 version 5.2.2);
---The test method for pulse energy has been changed (see 5.2.3, 5.2.1 in the.2018 version).
Please note that some content in this document may involve patents. The issuing organization of this document assumes no responsibility for identifying patents.
This document was proposed by the National Medical Products Administration.
This document is under the jurisdiction of the Standardization Technical Unit for Traditional Chinese Medicine Instruments (SMD/T U008).
The release history of this document and the document it replaces is as follows.
---First released in.2010 as YY 0780-2010, and revised for the first time in.2018;
---This is the second revision.
introduction
This document, as a dedicated standard for electroacupuncture therapy devices, takes precedence over the already published YY 9706.210 "Medical Electrical Equipment - Parts 2-10.
Requirements of the "Special Requirements for Basic Safety and Basic Performance of Nerve and Muscle Stimulators".
Traditional Chinese Medicine Electroacupuncture Therapy Instrument
1.Scope
This document specifies the requirements for electroacupuncture therapy devices (hereinafter referred to as "therapeutic devices") and describes the corresponding test methods.
This document applies to instruments that provide treatment and adjunctive therapy to patients via electroacupuncture.
2 Normative references
The contents of the following documents, through normative references within the text, constitute essential provisions of this document. Dated citations are not included.
For references to documents, only the version corresponding to that date applies to this document; for undated references, the latest version (including all amendments) applies.
This document.
GB 2024 Acupuncture Needles
GB 9706.1 Medical electrical equipment - Part 1.General requirements for basic safety and basic performance
GB/T 14710 Environmental requirements and test methods for medical electrical appliances
YY/T 0696-2021 Measurement of output characteristics of nerve and muscle stimulators
YY 9706.210-2021 Medical Electrical Equipment - Part 2-10.Basic Safety and Basic Performance of Nerve and Muscle Stimulators
Requirements
3.Terms and Definitions
The terms and definitions defined in YY 9706.210-2021, as well as the following terms and definitions, apply to this document.
3.1
An instrument that uses electroacupuncture to treat and assist patients.
Note. This typically includes the main unit, electrode wires, and electrode pin connectors, as well as the matching electrode pins.
3.2
Electroacupuncture
After the needle is inserted into the muscle tissue to obtain the needling sensation, a small current is passed through the needle. This dual stimulation of needling and electricity is used as an adjunct therapy for diseases.
method.
3.3
The acupuncture needles used in electroacupuncture therapy devices are connected to the electrode needle connector to conduct the current output by the therapy device to the muscle tissue.
3.4
Devices for connecting electrode wires to electrode needles include, but are not limited to, clip-on types.
3.5
Connect the electrode needle connector to the wires at the output terminals to transmit the output current of the therapeutic device.
Note. It consists of multiple sections, including adapters.
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