Traditional Chinese medicine - Infrared moxibustion-like instrument

This document specifies the requirements for infrared moxibustion-like instrument as a medical device.

Médecine traditionnelle chinoise — Instruments de moxibustion infrarouge

General Information

Status
Published
Publication Date
02-Aug-2018
Current Stage
9093 - International Standard confirmed
Start Date
17-Jun-2024
Completion Date
13-Dec-2025

Relations

Effective Date
06-Jun-2022

Overview

ISO 20493:2018 - Traditional Chinese medicine - Infrared moxibustion-like instrument - is an international standard that specifies safety, performance and testing requirements for infrared moxibustion-like instruments when used as medical devices. The standard defines device composition, required operating characteristics, protection against hazards, environmental and electrical testing, labeling, instructions for use, packaging, transportation and storage.

Key topics and technical requirements

  • Device structure: instrument components include the infrared heater, back shield, front shield and working shield.
  • Spectral output: the infrared moxibustion-like spectrum is primarily distributed in the 1 µm to 10 µm wavelength range.
  • Temperature control:
    • Heater surface temperature must be maintained within ±10% of the manufacturer’s rated value.
    • Surface temperature unevenness ≤ 20% across defined test points.
    • Maximum surface temperature of front, back and working shields ≤ 56 °C.
  • Time control:
    • Thermal response time ≤ 20 minutes (time to reach rated temperature).
    • Instrument must include an adjustable timer; timer accuracy error ≤ ±10% and must stop heating at set time with sound/light indication.
  • Overheat and radiation protection:
    • A reliable thermal protective device is required.
    • Protection against unwanted or excessive radiation follows IEC 60601-1 Clause 10.
  • Testing methods:
    • Wavelength testing with an infrared spectrometer.
    • Temperature testing: 9-point surface measurements after 20 min energization; unevenness calculation per formula in the standard.
    • Thermal response measured by contact thermocouple method.
  • Labeling and documentation: indelible label with production unit, model, input power, serial number, production date, registration and standards. Instructions must explain irradiation exposure times and safe distances.
  • Packaging & storage: moisture-proof, shock-resistant packing; storage suitable for packaged device at 40 °C to 55 °C, RH < 90%.

Applications and users

ISO 20493:2018 is intended for:

  • Manufacturers and designers of infrared moxibustion-like medical devices to meet safety and performance requirements.
  • Test laboratories performing conformity and type testing (spectral, thermal, EMC, electrical safety).
  • Regulatory authorities and conformity assessors reviewing device compliance.
  • Clinics and practitioners using infrared moxibustion devices who require guidance on labeling, safe irradiation exposure and storage/transport.

Related standards

  • IEC 60601-1 (medical electrical equipment - safety)
  • IEC 60601-1-2 (EMC for medical devices)
  • ISO 15223-1 (medical device symbols)
  • ISO/IEC Guide 37 (instructions for use)
  • ISO 780 (packaging handling symbols)

Keywords: ISO 20493:2018, infrared moxibustion-like instrument, traditional Chinese medicine, moxibustion, medical device standard, wavelength range, temperature control, thermal response, IEC 60601.

Standard

ISO 20493:2018 - Traditional Chinese medicine — Infrared moxibustion-like instrument Released:3. 08. 2018

English language
8 pages
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Frequently Asked Questions

ISO 20493:2018 is a standard published by the International Organization for Standardization (ISO). Its full title is "Traditional Chinese medicine - Infrared moxibustion-like instrument". This standard covers: This document specifies the requirements for infrared moxibustion-like instrument as a medical device.

This document specifies the requirements for infrared moxibustion-like instrument as a medical device.

ISO 20493:2018 is classified under the following ICS (International Classification for Standards) categories: 11.040.99 - Other medical equipment. The ICS classification helps identify the subject area and facilitates finding related standards.

ISO 20493:2018 has the following relationships with other standards: It is inter standard links to ISO 20500-7. Understanding these relationships helps ensure you are using the most current and applicable version of the standard.

You can purchase ISO 20493:2018 directly from iTeh Standards. The document is available in PDF format and is delivered instantly after payment. Add the standard to your cart and complete the secure checkout process. iTeh Standards is an authorized distributor of ISO standards.

Standards Content (Sample)


INTERNATIONAL ISO
STANDARD 20493
First edition
2018-08
Traditional Chinese medicine —
Infrared moxibustion-like instrument
Médecine traditionnelle chinoise — Instruments de moxibustion
infrarouge
Reference number
©
ISO 2018
© ISO 2018
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: +41 22 749 01 11
Fax: +41 22 749 09 47
Email: copyright@iso.org
Website: www.iso.org
Published in Switzerland
ii © ISO 2018 – All rights reserved

Contents Page
Foreword .iv
Introduction .v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Structure and composition . 2
5 Requirements . 2
5.1 Wavelength range . 2
5.2 Temperature control . 2
5.3 Time control . 2
5.4 Overheating protection . 3
5.5 Protection against unwanted and excessive radiation hazards . 3
5.6 Environmental testing requirements . 3
5.7 Electrical safety requirements. 3
5.8 Electromagnetic compatibility . 3
6 Test methods . 3
6.1 Wavelength range test . 3
6.2 Temperature control test . 3
6.2.1 Infrared heater surface temperature test . 3
6.2.2 Temperature unevenness test . 5
6.2.3 Shield temperature test . 5
6.3 Thermal response time test . 5
7 Labels, instruction, packaging, transportation and storage . 6
7.1 Labels . 6
7.2 Instruction for use . 7
7.3 Packaging . 7
7.4 Transportation . 7
7.5 Storage . 7
Bibliography . 8
Foreword
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URL: 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 © ISO 2018 – All rights reserved

Introduction
Moxibustion is a traditional Chinese medicine external therapy that uses moxa floss made from dried
mugwort. It plays an important role in traditional Chinese medicine. The heating effect and infrared
spectrum produced during the burning of mugwort has therapeutic effects due to the irradiation of the
channels and acupuncture points sites.
Based on traditional Chinese medicine, the infrared moxibustion-like instrument is a medical
device that simulates the heating effect and infrared spectrum of burning mugwort to irradiate the
acupuncture points and surrounding area of a human body for the treatment of a variety of diseases.
At present, the infrared mox
...

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