ISO 21292:2020

Traditional Chinese medicine - Electric heating moxibustion equipment

This document specifies general requirements for electrical heating moxibustion equipment. It is not applicable to infrared moxibustion equipment covered by ISO 20493 and smokeless moxibustion devices covered by ISO 21366.

Médecine traditionnelle chinoise — Équipements de moxibustion par chauffage électrique

General Information

• Status: Published
• Publication Date: 07-Jul-2020
• ICS: 11.040.99 - Other medical 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: 9060 - Close of review
• Completion Date: 04-Mar-2031

Overview

ISO 21292:2020 specifies general requirements for electric heating moxibustion equipment used in Traditional Chinese Medicine (TCM). This international standard ensures the safety, performance, and biocompatibility of devices designed to deliver heat through electrically heated units to skin or acupoints for therapeutic purposes. It excludes infrared moxibustion equipment covered by ISO 20493 and smokeless moxibustion devices regulated under ISO 21366.

This standard supports product consistency and regulatory compliance, promoting safe usage in clinical and home healthcare settings.

Key Topics

• Scope and Applicability
  Applies specifically to electrical heating moxibustion devices, defining requirements that do not overlap with infrared or smokeless moxibustion variants.

• Device Components
  Includes a control unit (with mains connection), output lines (if any), heating units, and optionally moxibustion pads. The heating unit delivers controlled heat to the skin or acupoints, while the moxibustion pad may be a replaceable element placed between the device and skin.

• Performance and Safety Requirements

  • Temperature Control: Precise temperature regulation is mandatory, with a maximum temperature not exceeding 60 °C ± 2 °C error margin. Devices must allow independent temperature adjustment for each heating unit.
  • Timing Functions: Equipped with timers adjustable from 1 to 60 minutes, with timing accuracy within ±5%.
  • Safety Features: Includes manual stop functions, temperature indication, audible and/or visual alarms for over-temperature, and an independent over-temperature protection system that automatically cuts power beyond safe limits.
  • Biocompatibility: All patient-contacting materials must comply with ISO 10993-1 standards for biological safety.

• Instructions and Labelling
  Clear user guides are required, addressing warnings (e.g., burn risk), device setup, recommended temperature and duration, contraindications (e.g., no use on skin ulcers or patients with reduced heat sensitivity), and supervision by healthcare professionals.
  Labeling on primary and secondary packaging must incorporate manufacturer details, product description, lot numbers, and expiry dates following ISO 15223-1.

Applications

ISO 21292:2020 is vital for manufacturers, healthcare providers, and regulatory authorities involved with:

• Traditional Chinese Medicine Clinics
  Ensuring moxibustion devices meet safety and performance standards for patient treatments.

• Medical Device Manufacturers
  Designing and producing electric heating moxibustion equipment that conforms with international regulations to facilitate global market access.

• Healthcare Practitioners
  Utilizing standardized equipment for safer and more effective moxibustion therapies.

• Home Healthcare
  Supporting the development of safe, easy-to-use moxibustion devices for personal therapeutic use under professional guidance.

Related Standards

• ISO 20493 – Traditional Chinese medicine - Infrared moxibustion-like instruments
• ISO 21366 – Traditional Chinese medicine - General requirements for smokeless moxibustion devices
• ISO 18666 – Traditional Chinese medicine - General requirements of moxibustion devices
• ISO 10993-1 – Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process
• ISO 15223-1 – Medical devices - Symbols to be used with medical device labels, labeling and information to be supplied - Part 1: General requirements
• IEC 60601-1 – Medical electrical equipment - Part 1: General requirements for basic safety and essential performance

By aligning with these complementary standards, ISO 21292:2020 helps maintain a comprehensive framework for the quality and safety of electric heating moxibustion equipment within the broader field of medical device regulation and traditional healing technologies.

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Keywords: electric heating moxibustion equipment, Traditional Chinese Medicine, ISO 21292, medical device safety, moxibustion device requirements, heating unit temperature control, biocompatibility, moxibustion pad, medical device standards, patient safety, healthcare equipment labeling.

Standards Content (Sample)

INTERNATIONAL ISO
STANDARD 21292
First edition
2020-07
Traditional Chinese medicine —
Electric heating moxibustion
equipment
Médecine traditionnelle chinoise — Équipements de moxibustion par
chauffage électrique
Reference number
©
ISO 2020
© ISO 2020
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 © ISO 2020 – All rights reserved

Contents Page
Foreword .iv
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Components . 2
5 Requirements and test methods . 2
5.1 Preparation . 2
5.2 Heating unit temperature . 2
5.3 Timing function . 3
5.4 Safety requirements . 3
5.5 Biocompatibility . 3
5.6 Instructions for use . 3
6 Package . 4
6.1 Primary packaging . 4
6.2 Secondary packaging . 4
7 Labelling . 4
7.1 General . 4
7.2 Primary and secondary packages . 4
Bibliography . 5
Foreword
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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 2020 – All rights reserved

INTERNATIONAL STANDARD ISO 21292:2020(E)
Traditional Chinese medicine — Electric heating
moxibustion equipment
1 Scope
This document specifies general requirements for electrical heating moxibustion equipment.
It is not applicable to infrared moxibustion equipment covered by ISO 20493 and smokeless moxibustion
devices covered by ISO 21366.
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) appli
...