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YY 0780-2025: Traditional Chinese medical device - Electroacupuncture therapy device
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Std ID	Version	USD	Buy	Deliver [PDF] in	Title (Description)
YY 0780-2025	English	279	Add to Cart	3 days [Need to translate]	Traditional Chinese medical device - Electroacupuncture therapy device
YY 0780-2018	English	199	Add to Cart	3 days [Need to translate]	Electroacupuncture therapy device
YY 0780-2010	English	399	Add to Cart	3 days [Need to translate]	Electroacupuncture therapy device

YY 0780-2025: Traditional Chinese medical device - Electroacupuncture therapy device

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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. ...