ISO 21291:2019

Traditional Chinese medicine —Therapeutic fumigation devices

This document specifies the requirements and test methods for therapeutic fumigation devices, hereafter referred to as the device. This document does not apply to decoction pieces.

Médecine traditionnelle chinoise — Dispositifs de fumigation thérapeutique

General Information

• Status: Published
• Publication Date: 26-May-2019
• ICS: 11.040.60 - Therapy 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 21291
First edition
2019-05
Traditional Chinese medicine —
Therapeutic fumigation devices
Médecine traditionnelle chinoise — Dispositifs de fumigation
thérapeutique
Reference number
ISO 21291:2019(E)
©
ISO 2019

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ISO 21291:2019(E)

COPYRIGHT PROTECTED DOCUMENT
© ISO 2019
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Published in Switzerland
ii © ISO 2019 – All rights reserved

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ISO 21291:2019(E)

Contents Page
Foreword .iv
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Classification and components . 2
4.1 Classification . 2
4.2 Components . 2
5 Technological requirements and test methods . 5
5.1 Temperature protection . 5
5.1.1 Temperature protection at steam outlet . 5
5.1.2 Temperature protection for fumigated body areas . 6
5.2 Temperature set function . 6
5.3 Temperature display function . 6
5.3.1 Open devices — skin temperature-sensing unit . 6
5.3.2 Closed devices — capsule temperature-sensing unit . 6
5.4 Temperature consistency in steam capsule . 7
5.5 Treatment timing . 7
5.6 Emergency stop function . 7
5.7 Heating prevention against empty decoction container . 7
5.8 Mechanical strength of patient support system . 7
5.9 Instructions for device use . 8
5.10 Electrical safety .
...