ISO 20493:2018
(Amendment)Traditional Chinese medicine — Infrared moxibustion-like instrument
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
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)
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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
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ISO 20493:2018(E)
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
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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