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
Current Stage
6060 - International Standard published
Start Date
27-Apr-2019
Completion Date
27-May-2019
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ISO 21291:2019 - Traditional Chinese medicine —Therapeutic fumigation devices
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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 21291:2019(E)
ISO 2019
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ISO 21291:2019(E)
COPYRIGHT PROTECTED DOCUMENT
© 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

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below or ISO’s member body in the country of the requester.
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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 ...................................................................................................................................................................................... 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

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.

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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
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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.
© ISO 2019 – All rights reserved 1
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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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