ISO 21366:2019

Traditional Chinese medicine — General requirements for smokeless moxibustion devices

This document specifies general requirements to ensure the performance and safety of smokeless moxibustion devices. It covers smoke density, moxibustion temperature, noxious gas and test methods for smokeless moxibustion devices. This document is applicable to any combustion-type device that claims to provide smokeless moxibustion. This document does not apply to devices that imitate moxibustion, such as electro moxibustion and infrared moxibustion devices.

Médecine traditionnelle chinoise — Exigences générales relatives à la moxibustion sans fumée

General Information

• Status: Published
• Publication Date: 09-May-2019
• 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: 9020 - International Standard under periodical review
• Start Date: 15-Apr-2024
• Completion Date: 15-Apr-2024

Standards Content (Sample)

INTERNATIONAL ISO
STANDARD 21366
First edition
2019-05
Traditional Chinese medicine —
General requirements for smokeless
moxibustion devices
Médecine traditionnelle chinoise — Exigences générales relatives à la
moxibustion sans fumée
Reference number
ISO 21366:2019(E)
©
ISO 2019

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ISO 21366:2019(E)

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ii © ISO 2019 – All rights reserved

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ISO 21366:2019(E)

Contents Page
Foreword .iv
Introduction .v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Test methods for smokeless moxibustion devices . 3
4.1 General . 3
4.2 Smoke density test . 3
4.3 Smoke generation test . 3
5 Safety requirements . 3
5.1 Noxious gas . 3
5.1.1 General. 3
5.1.2 Carbon monoxide (CO) . 4
5.1.3 Nitrogen dioxide (NO ) . 4
2
5.1.4 Total volatile organic compounds (tVOCs) . 4
5.1.5 Aldehyde . 4
5.2 Moxibustion temperature . 4
5.3 Device materials . 4
6 Packaging and labelling . 4
6.1 General
...