Traditional Chinese medicine -- Computerized tongue image analysis system

This document specifies general requirements for a computerized tongue image analysis system (CTIS). This document is limited to the safety aspects and technical requirements for a CTIS, excluding the diagnosis or interpretation of tongue images.

Médecine traditionnelle chinoise -- Système d’analyse d’images numérisées de la langue

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Status
Published
Publication Date
05-Mar-2019
Current Stage
6060 - International Standard published
Start Date
29-Jan-2019
Completion Date
06-Mar-2019
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ISO 20498-1:2019 - Traditional Chinese medicine -- Computerized tongue image analysis system
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INTERNATIONAL ISO
STANDARD 20498-1
First edition
2019-03
Corrected version
2019-05
Traditional Chinese medicine —
Computerized tongue image analysis
system —
Part 1:
General requirements
Médecine traditionnelle chinoise — Système d’analyse d’images
numérisées de la langue —
Partie 1: Exigences générales
Reference number
ISO 20498-1:2019(E)
ISO 2019
---------------------- Page: 1 ----------------------
ISO 20498-1:2019(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

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
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ISO 20498-1:2019(E)
Contents Page

Foreword ........................................................................................................................................................................................................................................iv

Introduction ..................................................................................................................................................................................................................................v

1 Scope ................................................................................................................................................................................................................................. 1

2 Normative references ...................................................................................................................................................................................... 1

3 Terms and definitions ..................................................................................................................................................................................... 1

4 Components of CTIS .......................................................................................................................................................................................... 2

5 Technical requirements ................................................................................................................................................................................ 2

5.1 General ........................................................................................................................................................................................................... 2

5.2 Tongue positioning .............................................................................................................................................................................. 2

5.3 Lighting part .............................................................................................................................................................................................. 2

5.4 Image acquisition part ...................................................................................................................................................................... 3

5.4.1 General...................................................................................................................................................................................... 3

5.4.2 Spatial resolution ............................................................................................................................................................ 3

5.4.3 Colour components ....................................................................................................................................................... 3

5.4.4 Colour components acquirement ...................................................................................................................... 4

5.5 Data processing part ......................................................................................................................................................................... 4

5.6 Display ............................................................................................................................................................................................................ 4

6 Safety ................................................................................................................................................................................................................................ 4

6.1 Safety of material .................................................................................................................................................................................. 4

6.2 Prevention from infection ............................................................................................................................................................. 4

6.3 General requirements for testing of ME equipment ............................................................................................... 4

6.4 Electrical hazards ................................................................................................................................................................................. 5

6.5 Mechanical hazards ............................................................................................................................................................................. 5

Annex A (informative) Tongue positioning .................................................................................................................................................... 6

Annex B (informative) Test methods for CTIS ............................................................................................................................................. 7

Annex C (informative) Data processing part ................................................................................................................................................ 9

Bibliography .............................................................................................................................................................................................................................11

© ISO 2019 – All rights reserved iii
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ISO 20498-1:2019(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.

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.

A list of all parts in the ISO 20498 series can be found on the ISO website.

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.

This corrected version of ISO 20498-1:2019 incorporates the following corrections:

— edition date in the running header changed to 2019;
— copyright date in the footer changed to 2019.
iv © ISO 2019 – All rights reserved
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ISO 20498-1:2019(E)
Introduction

The tongue’s colour, form, motion, substance and coating are the main factors to be considered when

analysing tongue features. Measuring the geometric shape involves observing the changes in the

thickness and size of a tongue and the cracks and teeth marks on its surface. The important features of

the tongue coating which cover the surface of the tongue are colour, degree of wetness, thickness, form

and distribution.

Although tongue diagnosis is convenient and non-invasive, it is difficult to achieve an objective and

standardized examination. Differences in inspection circumstances, such as light source or a client’s

posture, affect the result significantly. Moreover, as the diagnosis relies on the observer’s experience

and knowledge, it is hard to obtain a standardized result. Recently, many research projects have

attempted to solve these problems, and various types of computerized tongue image analysis system

(CTIS) have been developed.

Various cameras, such as a commercial digital camera, bayer charge-coupled device (CCD) camera,

high-performance 3CCD camera and a hyperspectral camera, were used for the CTIS. Recently, a multi-

view CTIS has been developed designed for 3D tongue modelling and sublingual vein acquirement,

comprising 3D CTIS.

Different CTIS technologies have unique advantages and specificities according to the application

and diagnostic environment, but this variation may cause inconsistent diagnoses in practical clinical

application. To improve CTIS performance and clinical approach, it has become necessary to develop an

International Standard for the functions and elements of a CTIS.
© ISO 2019 – All rights reserved v
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INTERNATIONAL STANDARD ISO 20498-1:2019(E)
Traditional Chinese medicine — Computerized tongue
image analysis system —
Part 1:
General requirements
1 Scope

This document specifies general requirements for a computerized tongue image analysis system (CTIS).

This document is limited to the safety aspects and technical requirements for a CTIS, excluding the

diagnosis or interpretation of tongue images.
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 for 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

ISO 20498-2, Traditional Chinese medicine — Computerized tongue image analysis system — Part 2: Light

environment

IEC 60601-1:2005/AMD1: 2012, Medical electrical equipment — Part 1: General requirements for basic

safety and essential performance
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
— IEC Electropedia: available at http: //www .electropedia .org/
3.1
computerized tongue image analysis system
CTIS
device or system used to acquire tongue images to be analysed by computer
3.2
charge-coupled device
CCD

device for the movement of electrical charge, usually from within the device to an area where the

charge can be manipulated
3.3
tongue positioning
guiding and maintaining the posture of the protruding tongue
© ISO 2019 – All rights reserved 1
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ISO 20498-1:2019(E)
3.4
lighting part

structure for illuminating the tongue surface with various light sources and optical techniques

3.5
image acquisition part
image sensor and optical lenses used to produce the
...

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