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
6060 - International Standard published
Start Date
30-Jun-2018
Completion Date
03-Aug-2018
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ISO 20493:2018 - Traditional Chinese medicine -- Infrared moxibustion-like instrument
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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 20493:2018(E)
ISO 2018
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ISO 20493:2018(E)
COPYRIGHT PROTECTED DOCUMENT
© ISO 2018

All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may

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Published in Switzerland
ii © ISO 2018 – All rights reserved
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ISO 20493:2018(E)
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

© ISO 2018 – All rights reserved iii
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ISO 20493:2018(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

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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

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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

complete listing of these bodies can be found at www .iso .org/members .html.
iv © ISO 2018 – All rights reserved
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ISO 20493:2018(E)
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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