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
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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
All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may
be reproduced or utilized otherwise in any form or by any means, electronic or mechanical, including photocopying, or posting
on the internet or an intranet, without prior written permission. Permission can be requested from either ISO at the address
below or ISO’s member body in the country of the requester.
ISO copyright office
CP 401 • Ch. de Blandonnet 8
CH-1214 Vernier, Geneva
Phone: +41 22 749 01 11
Fax: +41 22 749 09 47
Email: copyright@iso.org
Website: www.iso.org
Published in Switzerland
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
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
through ISO technical committees. Each member body interested in a subject for which a technical
committee has been established has the right to be represented on that committee. International
organizations, governmental and non-governmental, in liaison with ISO, also take part in the work.
ISO collaborates closely with the International Electrotechnical Commission (IEC) on all matters of
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).
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. ISO shall not be held responsible for identifying any or all such patent rights. Details of
any patent rights identified during the development of the document will be in the Introduction and/or
on the ISO list of patent declarations received (see www .iso .org/patents).
Any trade name used in this document is information given for the convenience of users and does not
constitute an endorsement.
For an explanation of the voluntary nature of standards, the meaning of ISO specific terms and
expressions related to conformity assessment, as well as information about ISO's adherence to the
World Trade Organization (WTO) principles in the Technical Barriers to Trade (TBT) see 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 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
...
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
All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may
be reproduced or utilized otherwise in any form or by any means, electronic or mechanical, including photocopying, or posting
on the internet or an intranet, without prior written permission. Permission can be requested from either ISO at the address
below or ISO’s member body in the country of the requester.
ISO copyright office
CP 401 • Ch. de Blandonnet 8
CH-1214 Vernier, Geneva
Phone: +41 22 749 01 11
Fax: +41 22 749 09 47
Email: copyright@iso.org
Website: www.iso.org
Published in Switzerland
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
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
through ISO technical committees. Each member body interested in a subject for which a technical
committee has been established has the right to be represented on that committee. International
organizations, governmental and non-governmental, in liaison with ISO, also take part in the work.
ISO collaborates closely with the International Electrotechnical Commission (IEC) on all matters of
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).
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. ISO shall not be held responsible for identifying any or all such patent rights. Details of
any patent rights identified during the development of the document will be in the Introduction and/or
on the ISO list of patent declarations received (see www .iso .org/patents).
Any trade name used in this document is information given for the convenience of users and does not
constitute an endorsement.
For an explanation of the voluntary nature of standards, the meaning of ISO specific terms and
expressions related to conformity assessment, as well as information about ISO's adherence to the
World Trade Organization (WTO) principles in the Technical Barriers to Trade (TBT) see 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 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
...
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