ISO 22587:2023

Traditional Chinese medicine — Acupoint magnetotherapy plasters for single use

This document specifies the requirements and test methods of single-use acupoint magnetotherapy plasters. For devices containing other medicine ingredients, this document only applies to the magnetotherapy functions of the device.

Médecine traditionnelle chinoise — Bande pour magnétothérapie sur les points d'acupuncture à usage unique

General Information

• Status: Published
• Publication Date: 26-Jun-2023
• 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: 27-Jun-2023
• Due Date: 17-Mar-2023
• Completion Date: 27-Jun-2023

Standards Content (Sample)

INTERNATIONAL ISO
STANDARD 22587
First edition
2023-06
Traditional Chinese medicine —
Acupoint magnetotherapy plasters for
single use
Médecine traditionnelle chinoise — Bande pour magnétothérapie sur
les points d'acupuncture à usage unique
Reference number
ISO 22587:2023(E)
© ISO 2023

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ISO 22587:2023(E)
COPYRIGHT PROTECTED DOCUMENT
© ISO 2023
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
CP 401 • Ch. de Blandonnet 8
CH-1214 Vernier, Geneva
Phone: [phone]
Email: [e-mail]
Website: www.iso.org
Published in Switzerland
ii
  © ISO 2023 – All rights reserved

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ISO 22587:2023(E)
Contents Page
Foreword .iv
Introduction .v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Requirements . 2
4.1 Material . 2
4.2 Appearance . 2
4.3 Magnetic strength . 2
4.3.1 Magnetic field strength . 2
4.3.2 Magnetic field leakage . 2
4.4 Adhesion strength . 2
4.5 Geometric . 2
4.5.1 Geometric dimensions of a plaster . 2
4.5.2 Geometric dimensions of a permanent magnet . 3
4.6 Biological evaluation . 3
5 Test methods . 3
5.1 Material . 3
5.2 Appearance . 3
5.3 Magnetic strength . 3
5.3.1 Magnetic field strength . 3
5.3.2 Magnetic field leakage . 3
5.4 Adhesion strength . 3
5.5 Geometry . 4
5.5.1 Geometric dimensions of a plaster . 4
5.5.2 Geometric dimensions of a permanent magnet . 4
6 Packaging and labelling . 4
6.1 Packaging . 4
6.2 Labelling . 4
7 Instructions for use . .4
Annex A (informative) Example of measurement positions . 6
Bibliography . 8
iii
© ISO 2023 – All rights reserved

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ISO 22587:2023(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.
iv
  © ISO 2023 – All rights reserved

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ISO 22587:2023(E)
Introduction
Acupoint magnetotherapy is a method of using a magnetic field to act on the acupuncture points of the
human body. It is also called magnetic acupoint therapy, meridian magnetic field therapy and acupoint
magnetic bead therapy.
The use of natural magnets for the treatment of diseases has long been recorded in China. Shen Nong's
[1]
Materia Medica prescribed the use of magnets as medicine. According to this book, magnetism (ci)
stone is pungent and cold and magnets are used to treat arthralgia, rheumatism and pain in the limbs,
as well as fever and deafness. The Ming Dynasty pharmacist Li Shizhen's Compendium of Materia
[2]
Medica also claims that magnetite placed on specific acupoints can be used to treat swelling, rectal
prolapse and other diseases. This indicates that magnetic therapy was associated with meridians and
acupoints during the Ming Dynasty. There are also records of the use of magnets to treat diseases in the
[3]
most recent edition of modern prescriptions, such as Medical Philosophy.
v
© ISO 2023 – All rights reserved

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INTERNATIONAL STANDARD ISO 22587:2023(E)
Traditional Chinese medicine — Acupoint magnetotherapy
plasters for single use
1 Scope
This document specifies the requirements and test methods of single-use acupoint magnetotherapy
plasters.
For devices containing other medicine ingredients, this document only applies to the magnetotherapy
functions of the device.
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
...

DRAFT INTERNATIONAL STANDARD
ISO/DIS 22587
ISO/TC 249 Secretariat: SAC
Voting begins on: Voting terminates on:
2022-06-08 2022-08-31
Traditional Chinese Medicine — Acupoint magnetotherapy
plaster for single use
ICS: 11.040.60
THIS DOCUMENT IS A DRAFT CIRCULATED
FOR COMMENT AND APPROVAL. IT IS
THEREFORE SUBJECT TO CHANGE AND MAY
This document is circulated as received from the committee secretariat.
NOT BE REFERRED TO AS AN INTERNATIONAL
STANDARD UNTIL PUBLISHED AS SUCH.
IN ADDITION TO THEIR EVALUATION AS
BEING ACCEPTABLE FOR INDUSTRIAL,
TECHNOLOGICAL, COMMERCIAL AND
USER PURPOSES, DRAFT INTERNATIONAL
STANDARDS MAY ON OCCASION HAVE TO
BE CONSIDERED IN THE LIGHT OF THEIR
POTENTIAL TO BECOME STANDARDS TO
WHICH REFERENCE MAY BE MADE IN
Reference number
NATIONAL REGULATIONS.
ISO/DIS 22587:2022(E)
RECIPIENTS OF THIS DRAFT ARE INVITED
TO SUBMIT, WITH THEIR COMMENTS,
NOTIFICATION OF ANY RELEVANT PATENT
RIGHTS OF WHICH THEY ARE AWARE AND TO
PROVIDE SUPPORTING DOCUMENTATION. © ISO 2022

---------------------- Page: 1 ----------------------
ISO/DIS 22587:2022(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
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
CP 401 • Ch. de Blandonnet 8
CH-1214 Vernier, Geneva
Phone: [phone]
Email: [e-mail]
Website: www.iso.org
Published in Switzerland
ii
  © ISO 2022 – All rights reserved

---------------------- Page: 2 ----------------------
ISO/DIS 22587:2022(E)
Contents Page
Foreword .iv
Introduction .v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Requirements . 2
4.1 Material . 2
4.2 Appearance . 2
4.3 Magnetic strength . 2
4.3.1 Magnetic field strength . 2
4.3.2 Magnetic field leakage . 2
4.4 Adhesion strength . 2
4.5 Geometric . 2
4.5.1 Geometric dimension of plaster . 2
4.5.2 Geometric dimension of permanent magnet . 2
4.6 Biological evaluation . 3
5 Test methods . 3
5.1 Material . 3
5.2 Appearance . 3
5.3 Magnetic strength . 3
5.3.1 Magnetic field strength . 3
5.3.2 Magnetic field leakage . 3
5.4 Adhesion strength . 3
5.5 Geometric . 3
5.5.1 Geometric dimension of plaster . 3
5.5.2 Geometric dimension of permanent magnet . 3
6 Packing and Labelling . 4
6.1 Packing . 4
6.2 Labelling . 4
7 Instructions for use . .4
Biography . 5
iii
© ISO 2022 – All rights reserved

---------------------- Page: 3 ----------------------
ISO/DIS 22587:2022(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.
iv
  © ISO 2022 – All rights reserved

---------------------- Page: 4 ----------------------
ISO/DIS 22587:2022(E)
Introduction
...