ISO 24571:2022

Traditional Chinese medicine - General requirements for the basic safety and essential performance of electro-acupuncture stimulators

This document specifies general requirements for the basic safety and essential performance of electro-acupuncture (EA) stimulators. It is not applicable to acupuncture needles, transcutaneous electrical nerve stimulators or electrical nerve and muscle stimulators.

Médecine traditionnelle chinoise — Exigences générales pour la sécurité de base et les performances essentielles des stimulateurs d'électroacupuncture

General Information

• Status: Published
• Publication Date: 06-Jun-2022
• ICS: 11.040.60 - Therapy equipment
• Technical Committee: ISO/TC 249 - Traditional Chinese medicine
• Drafting Committee: ISO/TC 249/WG 4 - Quality and safety of medical devices other than acupuncture needles
• Current Stage: 6060 - International Standard published
• Start Date: 07-Jun-2022
• Due Date: 19-Jun-2022
• Completion Date: 07-Jun-2022

Overview - ISO 24571:2022 (electro-acupuncture stimulators)

ISO 24571:2022, "Traditional Chinese medicine - General requirements for the basic safety and essential performance of electro-acupuncture stimulators," sets out the general safety and performance expectations for electro-acupuncture (EA) stimulators. The standard applies specifically to electrical medical equipment that delivers low‑frequency electrical stimulation via acupuncture needles and excludes acupuncture needles alone, transcutaneous electrical nerve stimulators and conventional nerve and muscle stimulators.

Key topics and technical requirements

ISO 24571:2022 addresses the full safety/performance lifecycle for EA stimulators and references core medical electrical requirements from the IEC 60601 family. Major technical topics covered include:

• Scope and definitions - clear definitions for EA, EA stimulators, leads, needle clips and applied parts.
• General safety and testing - alignment with IEC 60601‑1 for basic safety and essential performance; specific testing requirements when electrodes are open- or short‑circuited (see Annex B).
• Classification and protection - medical electrical (ME) classification, protection against electric shock (Type B applied parts excluded) and mode-of-operation requirements.
• Identification, marking and documentation - electrical input, labeling and comprehensive instructions for use.
• Electrical and mechanical hazards - protection against hazardous outputs, disconnection prevention, excessive radiation and temperature hazards; construction guidance including needle clips and leads.
• Controls, accuracy and usability - requirements for output amplitude, pulse parameters, independent multi‑channel control, usability (IEC 60601‑1‑6) and alarm systems (IEC 60601‑1‑8).
• Electromagnetic compatibility (EMC) - emissions and immunity testing for EA stimulators, including patient-lead considerations and special cases for acupuncture-needle connections.
• Programmable systems and fault handling - guidance for Programmable Electrical Medical Systems (PEMS), hazardous situations and fault-condition management.
• Informative and normative annexes - system configurations, detailed test methods, impedance testing and discussion of excessive total current per session.

Applications - who uses ISO 24571:2022

This standard is practical for:

• Manufacturers and designers of EA stimulators ensuring product safety, performance and regulatory readiness.
• Test laboratories and conformity assessors performing IEC/ISO‑based safety and EMC testing (refer to Annex B and Annex D).
• Regulatory authorities and procurement teams evaluating medical electrical equipment for clinical use in traditional Chinese medicine (TCM).
• Clinicians and facility risk managers who need to understand device safety characteristics and labeling/instructions for use.
• Standards developers and technical committees working on TCM device harmonization.

Related standards

• IEC 60601‑1 (General requirements for basic safety and essential performance)
• IEC 60601‑1‑2 (EMC)
• IEC 60601‑1‑6 (Usability)
• IEC 60601‑1‑8 (Alarm systems)
• ISO 20487 (referenced for EA stimulator definition)

ISO 24571:2022 is essential for ensuring that electro-acupuncture stimulators meet internationally recognized safety and essential‑performance criteria within the context of traditional Chinese medicine.

Standards Content (Sample)

INTERNATIONAL ISO
STANDARD 24571
First edition
2022-06
Traditional Chinese medicine —
General requirements for the basic
safety and essential performance of
electro-acupuncture stimulators
Médecine traditionnelle chinoise — Exigences générales pour la
sécurité de base et les performances essentielles des stimulateurs
d'électroacupuncture
Reference number
© ISO 2022
All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may
be reproduced or utilized otherwise in any form or by any means, electronic or mechanical, including photocopying, or posting on
the internet or an intranet, without prior written permission. Permission can be requested from either ISO at the address below
or ISO’s member body in the country of the requester.
ISO copyright office
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CH-1214 Vernier, Geneva
Phone: [phone]
Email: [e-mail]
Website: www.iso.org
Published in Switzerland
ii
Contents Page
Foreword .v
Introduction . vi
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 General requirements . 2
4.1 General . 2
5 General requirements for testing EA stimulators. 2
6 Classification of EA stimulators in medical electrical (ME) equipment and ME
systems . 2
6.1 General . 2
6.2 Protection against electric shock . 2
6.3 Mode of operation . 2
7 Identification, marking and documents of EA stimulators . 2
7.1 General . 2
7.2 Electrical input power from the supply mains . 3
7.3 Instructions for use . 3
7.3.1 General . 3
7.3.2 Additional information . 3
8 Protection against electrical hazards from EA stimulators . 3
8.1 General . 3
8.2 Classification of applied parts . 3
9 Protection against mechanical hazards of EA stimulators . 3
9.1 General . 3
9.2 Disconnection prevention . 4
10 Protection against unwanted and excessive radiation hazards . 4
11 Protection against excessive temperatures and other hazards .4
12 Accuracy of controls and instruments and protection against hazardous outputs .4
12.1 Accuracy of controls and instruments . 4
12.1.1 General . 4
12.1.2 Output amplitude . 4
12.1.3 Pulse parameters . 4
12.1.4 Independent control of multiple output channels . 4
12.2 Usability of ME equipment . 5
12.3 Alarm systems . 5
12.4 Protection against hazardous output . 5
12.4.1 General . 5
12.4.2 Supply voltage fluctuations . 5
12.4.3 Output interlock . 5
12.4.4 Output indicator. 5
12.4.5 Limitation of output parameters . 5
13 Hazardous situations and fault conditions . 6
14 Programmable electrical medical systems (PEMS) . 6
15 Construction of ME equipment . 6
15.1 General . 6
15.2 Needle clips and leads . 6
16 ME systems . 6
iii
17 Electromagnetic compatibility of ME equipment and ME system .6
18 Electromagnetic compatibility – requirements and tests . 6
18.1 General . 6
18.2 Emissions tests . 6
18.2.1 General . 6
18.2.2 Patient lead . 6
18.3 Immunity . 6
18.3.1 General . 6
18.3.2 EA stimulator with acupuncture needle . 7
Annex A (informative) Configuration of EA stimulator system . 8
Annex B (normative) Test methods for EA stimulator . 9
Annex C (informative) The safety issue of excessive total current per session .10
Annex D (informative) Test methods for EA stimulator for various impedance conditions .11
Bibliography .12
iv
Foreword
ISO (the International Organization for Standardization) is a worldwide federation of national standards
bodies (ISO member bodies). The work of preparing International Standards is normally carried out
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ISO collaborates closely with the International Electrotechnical Commission (IEC) on all matters of
electrotechnical standardization.
The procedures used to develop this document and those intended for its further maintenance are
described in the ISO/IEC Directives, Part 1. In particular, the different approval criteria needed for the
different types of ISO documents should be noted. This document was drafted in accordance with the
editorial rules of the ISO/IEC Directives, Part 2 (see www.iso.org/directives).
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. ISO shall not be held responsible for identifying any or all such patent rights. Details of
any patent rights identified during the development of the document will be in the Introduction and/or
on the ISO list of patent declarations received (see www.iso.org/patents).
Any trade name used in this document is information given for the convenience of users and does not
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For an explanation of the voluntary nature of standards, the meaning of ISO specific terms and
expressions related to conformity assessment, as well as information about ISO's adherence to
the World Trade Organization (WTO) principles in the Technical Barriers to Trade (TBT), see
www.iso.org/iso/foreword.html.
This document was prepared by Technical Committee ISO/TC 249, Traditional Chinese medicine.
Any feedback or questions on this document should be directed to the user’s national standards body. A
complete listing of these bodies can be found at www.iso.org/members.html.
v
Introduction
Acupuncture is an ancient healing technique in traditional Chinese medicine (TCM) which has been
used for more than 2400 years. Traditional acupuncture treatment is performed by twisting needles
manually. The application of electrical stimulation to acupuncture needles was first attempted in the
first half of the 19th century by a French doctor, Sarlandiere. Acupuncture treatment began to attract
[7]
the attention of medical practitioners in the 1970s after the report of acupuncture anaesthesia.
Today, electro-acupuncture (EA) stimulators are widely used in acupuncture treatment.
This document specifies the basic safety and essential performance for EA stimulators as medical
electrical equipment. IEC 60601-2-10 on nerve and muscle stimulators excludes any medical electrical
equipment intended to be implanted or connected to implanted electrodes. In terms of safety, the
most important difference between the two techniques is what type of electrodes are used to deliver
stimulation current. Acupuncture needles are inserted into the body in EA, whereas skin electrodes
are used in nerve and muscle stimulation. Electro-acupuncture can cause tissue damage when the
stimulating energy is too high or needle corrosion occurs when direct current component is applied. It
is generally accepted that certain parameters of the pulses are essential for the therapeutic effect of EA.
vi
INTERNATIONAL STANDARD ISO 24571:2022(E)
Traditional Chinese medicine — General requirements
for the basic safety and essential performance of electro-
acupuncture stimulators
1 Scope
This document specifies general requirements for the basic safety and essential performance of electro-
acupuncture (EA) stimulators.
It is not applicable to acupuncture needles, transcutaneous electrical nerve stimulators or electrical
nerve and muscle stimulators.
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+A1: 2012, Medical electrical equipment — Part 1: General requirements for basic safety
and essential performance
IEC 60601-1-2:2014, Medical electrical equipment — Part 1-2: General requirements for basic safety and
essential performance — Collateral standard: Electromagnetic disturbances — Req
...