ISO 21291:2019
(Main)Traditional Chinese medicine —Therapeutic fumigation devices
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
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)
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© ISO 2019
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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 . 8
5.11 Electromagnet disturbances . 8
5.12 Biological evaluation . 8
© ISO 2019 – All rights reserved iii
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ISO 21291:2019(E)
Foreword
ISO (the International Organization for Standardization) is a worldwide federation of national standards
bodies (ISO member bodies). The work of preparing International Standards is normally carried out
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electrotechnical standardization.
The procedures used to develop this document and those intended for its further maintenance are
described in the ISO/IEC Directives, Part 1. In particular, the different approval criteria needed for the
different types of ISO documents should be noted. This document was drafted in accordance with the
editorial rules of the ISO/IEC Directives, Part 2 (see www .iso .org/directives).
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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
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iv © ISO 2019 – All rights reserved
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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.
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ISO 21291:2019(E)
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
...
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