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

Relations

• Consolidated By: ISO 12185:2024 - Crude petroleum, petroleum products and related products - Determination of density - Laboratory density meter with an oscillating U-tube sensor
• Effective Date: 06-Jun-2022

Overview

ISO 22587:2023 specifies requirements and test methods for single‑use acupoint magnetotherapy plasters used in Traditional Chinese Medicine (TCM). The standard covers the magnetotherapy function of plasters that contain permanent magnets and applies where products also include other medicinal ingredients - limited to their magnetic function. It defines material, appearance, magnetic strength, adhesion, geometry, biological evaluation, packaging, labelling and instructions for use.

Keywords: ISO 22587:2023, acupoint magnetotherapy plasters, Traditional Chinese Medicine, single‑use magnet plasters, magnetic field strength.

Key topics and technical requirements

• Magnetic field strength: Target maximum magnetic field strength range 35 mT to 400 mT; measurement error must not exceed 5%. Manufacturers must declare maximum field strength and flux shape.
• Magnetic field leakage: If average maximum field strength exceeds 60 mT at 5 mm from the magnet surface, this must be stated on the package or instructions.
• Adhesion: Adhesive between plaster and permanent magnet must be at least 10 times the magnet’s weight; plaster–skin adhesion tested per ISO 29862.
• Geometry: Plaster dimensions must be more than double the permanent magnet’s dimensions. Permanent magnet minimum diameter ≥ 1 mm (or minimum cross‑sectional area ≥ 1 mm² for special shapes).
• Material & appearance: Manufacturers must declare magnet material in line with IEC 60404‑8‑1; magnets must be free of sharp edges and burrs.
• Biological evaluation: Skin‑contact parts must meet biocompatibility assessment per ISO 10993‑1.
• Packaging & labelling: Sealed, non‑resealable packaging that protects contents; labelling to conform with ISO 15223‑1 and include manufacturer, contents, LOT, manufacture/expiry date (if sterile), “single use” statement, and polarity/position marking.
• Test methods: Use gauss meters for magnetic strength; a spherical non‑magnetic case method is specified for leakage measurements; adhesion and geometry inspection procedures defined.

Applications and users

• Practical use: Ensures safety, performance and traceability of single‑use acupoint magnetotherapy plasters applied to acupuncture points for therapeutic magnetic stimulation.
• Who uses it:
  • Manufacturers and product designers of TCM magnetotherapy plasters
  • Regulatory bodies and conformity assessors
  • Quality and R&D teams performing product testing and labelling
  • Clinical practitioners and TCM clinics selecting compliant single‑use magnet plasters

Related standards

• ISO 10993‑1 - Biological evaluation of medical devices
• ISO 29862 - Self‑adhesive tapes - Peel adhesion properties
• IEC 60404‑8‑1 - Magnetic materials (magnetically hard)
• ISO 8124‑1 - Safety aspects related to mechanical/physical properties (referenced for precautions)
• ISO 15223‑1 - Medical device symbols for labelling

This concise summary helps manufacturers and practitioners understand ISO 22587:2023 requirements for safe, effective single‑use acupoint magnetotherapy plasters and supports compliant product design, testing and labelling.

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 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
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
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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expressions related to conformity assessment, as well as information about ISO's adherence to
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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
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iv
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
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
...