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

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 24571:2022(E)
© ISO 2022

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ISO 24571:2022(E)
COPYRIGHT PROTECTED DOCUMENT
© ISO 2022
All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may
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ISO 24571:2022(E)
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
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ISO 24571:2022(E)
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
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ISO 24571:2022(E)
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
through ISO technical committees. Each member body interested in a subject for which a technical
committee has been established has the right to be represented on that committee. International
organizations, governmental and non-governmental, in liaison with ISO, also take part in the work.
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
constitute an endorsement.
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.
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ISO 24571:2022(E)
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.
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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
...