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YY 0780-2025Traditional Chinese medical device - Electroacupuncture therapy device (English PDF)

中医器械电针治疗仪

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Issued by

NMPA

Level / Type

Industry · Mandatory

Issue date

June 18, 2025

Implementation date

July 1, 2028

Scope

YY 0780-2025 is the English-translated version of 中医器械电针治疗仪.

YY 0780-2025 is the Chinese standard "Traditional Chinese medical device - Electroacupuncture therapy device". Its scope clause reads: 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. Its clauses include terms and definitions.

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Document preview — YY 0780-2025

National Standard of the People's Republic of China

ICS: 11.040.60
Classification: G42
Replacing: YY 0780-2018

Issued by: National Medical Products Administration

Preface
Introduction
1.Scope
2 Normative References
3.Terms and Definitions
4 Requirements
5.Test Methods

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.

......
This preview omits tables, figures, formulas and parts of the technical clauses. The complete document — 8 pages — is available in the English PDF.

Referenced standards

Normative references

Cited by

GB/T 40973-2021Basic service specification for acupuncture and moxibustion clinic

Similar standards

MT/T 914|MT/T 668|GB/T 1171

Editions of YY 0780

Edition	Title	Revision	Status
YY 0780-2025	Traditional Chinese medical device - Electroacupuncture therapy device	current edition	Current
YY 0780-2018	Traditional Chinese medical device - Electroacupuncture therapy device	previous edition	In force until 2028-07-01

This page sells the current edition, YY 0780-2025. Earlier editions are listed for reference only.

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