ISO 20493:2018

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
• 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: 6060 - International Standard published
• Start Date: 03-Aug-2018
• Completion Date: 03-Aug-2018

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 20493:2018(E)
ISO 2018
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ISO 20493:2018(E)
COPYRIGHT PROTECTED DOCUMENT
© ISO 2018

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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

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bodies (ISO member bodies). The work of preparing International Standards is normally carried out

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described in the ISO/IEC Directives, Part 1. In particular the different approval criteria needed for the

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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 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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