ISO 21291:2019

INTERNATIONAL ISO
STANDARD 21291
First edition
2019-05
Traditional Chinese medicine —
Therapeutic fumigation devices
Médecine traditionnelle chinoise — Dispositifs de fumigation
thérapeutique
Reference number
©
ISO 2019
© ISO 2019
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ii © ISO 2019 – All rights reserved

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 . 8
5.11 Electromagnet disturbances . 8
5.12 Biological evaluation . 8
Foreword
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iv © ISO 2019 – All rights reserved

INTERNATIONAL STANDARD ISO 21291:2019(E)
Traditional Chinese medicine — Therapeutic fumigation
devices
1 Scope
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.
2 Normative references
The following documents are referred to in the text in such a way that some or all of their content
constitutes requirements of this document. For dated references, only the edition cited applies. For
undated references, the latest edition of the referenced document (including any amendments) applies.
ISO 10993-1, Biological evaluation of medical devices — Part 1: Evaluation and testing within a risk
management process
IEC 60601-1:2005/AMD1: 2012, Medical electrical equipment — Part 1: General requirements for basic
safety and essential performance
IEC 60601-1-2, Medical electrical equipment — Part 1-2: General requirements for basic safety and essential
performance — Collateral standard: Electromagnetic disturbances — Requirements and tests
IEC 60601-2-52, Medical electrical equipment — Part 2-52: Particular requirements for the basic safety
and essential performance of medical beds
IEC 60601-1-8, Medical electrical equipment — Part 1-8: General requirements for basic safety and
essential performance — Collateral standard: General requirements, tests and guidance for alarm systems
in medical electrical equipment and medical electrical systems
3 Terms and definitions
For the purposes of this document, the following terms and definitions apply.
ISO and IEC maintain terminological databases for use in standardization at the following addresses:
— ISO Online browsing platform: available at https: //www .iso .org/obp
— IECElectropedia: available at http: //www .electropedia .org/
3.1
therapeutic fumigation device
device that heats liquid decoction pieces to form steam
Note 1 to entry: The steam is used therapeutically.
3.2
closed therapeutic fumigation device
therapeutic fumigation device which uses an enclosed capsule for treatment
Note 1 to entry: During treatment, the steam and areas of the patient’s body undergoing therapeutic fumigation
are predominantly isolated from the surrounding environment.
3.3
open therapeutic fumigation device
therapeutic fumigation device which does not use an enclosed capsule for treatment
Note 1 to entry: During treatment, both the steam and areas of the patient’s body undergoing therapeutic
fumigation are exposed to the surrounding environment.
4 Classification and components
4.1 Classification
The device is classified according to the body area being treated and the fumigation method being
applied.
a) Local type and full-body type can be classified by body area being treated (see Figure 1 and
Figure 3).
b) Open therapeutic fumigation devices and closed therapeutic fumigation devices, hereinafter
referred to as open devices
...