ISO 24996:2026

International
Standard
ISO 24996
First edition
Traditional Chinese medicine —
2026-09
General requirements and
recommendations for the basic
safety and essential performance
of the transcutaneous electrical
acupoint stimulators
Médecine traditionnelle chinoise — Exigences générales et
recommandations pour la sécurité de base et les performances
essentielles des stimulateurs électriques transcutanés d'acupoints
Reference number
© ISO 2026
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ii
Contents Page
Foreword .iv
Introduction .v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 General requirements . 2
5 General requirements for testing TEAS . 2
6 Classification of TEAS in medical electrical (ME) equipment and ME systems . 2
7 Identification, marking and documents of TEAS. 3
7.1 General .3
7.2 Marking on the outside of TEAS or TEAS parts .3
7.3 Marking of controls and instruments .3
7.4 Accompanying documents .3
8 Protection against electrical hazards from TEAS . 3
9 Protection against mechanical hazards from TEAS in ME equipment and ME systems . 3
10 Protection against unwanted and excessive radiation hazards . 3
11 Protection against excessive temperatures and other hazards . 3
12 Accuracy of controls and instruments and protection against hazardous outputs . 4
12.1 General .4
12.2 Accuracy of controls and instruments .4
12.2.1 Pulse width range.4
12.2.2 Frequency range .4
12.2.3 Intensity range .4
12.2.4 Current density of the electrode contact area .4
12.3 Protection against hazardous outputs.4
12.3.1 General .4
12.3.2 Supply voltage fluctuations .5
12.3.3 Output interlock .5
12.3.4 Output indicator.5
12.3.5 Safety criteria for stimulation signals .5
13 Hazardous situations and fault conditions . 5
14 Programmable electrical medical systems (PEMS) . 5
15 Construction of ME equipment . 5
15.1 General .5
15.2 Electrodes and clips .5
15.2.1 General .5
15.2.2 The area of the electrode .5
15.2.3 Auricular electrodes and clips .6
15.2.4 The adhesive force of the electrode.7
15.3 Lead .7
15.4 Operation of electrodes in fault circuit condition .7
16 ME systems . 7
17 Electromagnetic compatibility of ME equipment and ME systems . 7
Annex A (informative) Rationale for key output parameter limits of TEAS . 8
Bibliography . 9

iii
Foreword
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This document was prepared by Technical Committee ISO/TC 249, Traditional medicine, Subcommittee SC 1,
Traditional Chinese medicine.
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iv
Introduction
Acupuncture is the vanguard in the internationalization of traditional Chinese medicine. It has been adopted
and practiced in 196 countries or regions around the world. Transcutaneous electrical acupoint stimulation
is a non-invasive acupuncture application.
Transcutaneous electrical acupoint stimulators (TEAS) have been produced to meet the need of this
non-invasive acupuncture technique. Currently, many TEAS are available on the market. However, most
manufacturers did not indicate the output parameters comprehensively. There are no international
standards guiding the manufacture and processing to ensure safety and performance. The growing interest
and increasing use of TEAS, combined with increasing patients’ expectations and concerns about the safety
and performance of transcutaneous electrical acupoint stimulation, have given rise to the need to improve
the safety and performance through implementation of an International Standard.
It is extensively accepted that the output parameters are significant to ensuring the basic safety and
essential performance of the TEAS.

v
International Standard ISO 24996:2026(en)
Traditional Chinese medicine — General requirements
and recommendations for the basic safety and essential
performance of the transcutaneous electrical acupoint
stimulators
1 Scope
This document specifies general requirements for the basic safety and essential performance of
transcutaneous electrical acupoint stimulators (TEAS) with a focus on devices intended to stimulate
acupoints on the human body.
It applies to all types of TEAS specifically designed for acupoint-related therapeutic usage, only in the context
of professional traditional Chinese medicine (TCM) healthcare services.
It is not applicable to invasive electro-acupuncture stimulators for the application of electric currents via
acupuncture needles inserted into the body.
2 Normative references
The following documents are referred to in the text in such a way that some or all of their content constitutes
requirements of this document. For dated references, only the edition cited applies. For undated references,
the latest edition of the referenced document (including any amendments) applies.
IEC 60601-1:2005+AMD1: 2012, Medical electrical equipment—Part 1: General requirements for basic safety
and essential performance
IEC 60601-1-2:2014+AMD1: 2020, Medical electrical equipment—Part 1-2: General requirements for basic safety
and essential performance—Collateral Standard: Electromagnetic disturbances—Requirements and tests
IEC 60601-2-10:2012+AMD1: 2016, Medical electrical equipment—Part 2-10: Particular requirements for the
basic safety and essential performance of nerve and muscle stimulators
3 Terms and definitions
For the purposes of this document, the following terms and definitions apply.
ISO and IEC maintain terminology databases for use in standardization at the following addresses:
— ISO Online browsing platform: available at https:// www .iso .org/ obp
— IEC Electropedia: available at https:// www .electropedia
...