ISO 20334:2018

Traditional Chinese medicine — Coding system of formulae

This document specifies rules to encode formulae, and gives specific codes for 1 233 frequently-used formulae. Chinese patent medicines (CPM) are outside the scope of this document. Kampo formulae are outside of the scope of this document. This document is applicable to formula-relating databases in fields of clinical medication, scientific research and teaching, electronic medical records and prescription of traditional Chinese medicine (TCM).

Médecine traditionnelle chinoise — Système de codification des formules

General Information

• Status: Published
• Publication Date: 07-Jun-2018
• ICS: 11.120.10 - Medicaments
• Technical Committee: ISO/TC 249 - Traditional Chinese medicine
• Drafting Committee: ISO/TC 249 - Traditional Chinese medicine
• Current Stage: 9093 - International Standard confirmed
• Completion Date: 28-Mar-2024

Standards Content (Sample)

INTERNATIONAL ISO
STANDARD 20334
First edition
2018-06
Traditional Chinese medicine —
Coding system of formulae
Médecine traditionnelle chinoise — Système de codification des
formules
Reference number
©
ISO 2018
© ISO 2018
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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ii © ISO 2018 – All rights reserved

Contents Page
Foreword . iv
Introduction . v
1  Scope . 1
2  Normative references . 1
3  Terms and definitions . 1
4  Coding principles . 2
4.1  Uniqueness . 2
4.2  Scalability . 2
4.3  Stability . 3
5  Coding technology . 3
5.1  Structure . 3
5.2  Detailed description . 3
5.2.1  Layer 1 . 3
5.2.2  Layer 2 . 3
5.2.3  Layer 3 . 3
5.2.4  Layer 4 . 3
5.2.5  Layer 5 . 4
5.2.6  Layer 6 . 4
5.2.7  Layer 7 . 4
6  Example . 7
Annex A (normative) Calculation of check digit . 8
Annex B (normative) Codes of formulae . 9
Annex C (normative) Codes of Korean formulae . 260
Bibliography . 277

© ISO 2018 – All rights reserved iii

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 on 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 the following
URL: www.iso.org/iso/foreword.html.
This document was prepared by ISO/TC 249, Traditional Chinese medicine.
iv © ISO 2018 – All rights reserved

Introduction
The botanical market has great potential; botanical research has been highly regarded and Chinese
medicines are gradually becoming increasingly recognized and approved in international markets.
Many countries have achieved remarkable success in the exploitation of Chinese medicines, including
the application of alternative therapies and the search for pharmaceutical sources. More and more
countries are becoming involved in the Chinese medicines trade. At present, the annual sale of Chinese
medicines has reached more than USD 16 billion, and is increasing at a rate of 10 % to 20 % per year.
More than 70 countries have established Chinese medicines regulations. Many countries are developing
traditional medicine vigorously, which brings more opportunities for trade and exchange in Chinese
medicines.
The purpose of this document is to:
1) specify coding rules for formulae, identify 1 233 formulae, ensure safe and effective application of
formulae;
2) assist practitioners to use formulae correctly, and promote standardization, normalization and
informatization of formula administration;
3) promote the wide application of TCM electronic medical records and prescriptions;
4) enable source‐tracing and controllability of electronic medical records and prescriptions in
procedures of diagnosis and prescribing, in order to build a more fair and transparent information
system;
5) expand the international academic exchange of formulae, and provide technical support for the
standardization of prescribing;
6) help different countries to establish a standard management system of formulae and Chinese
medicine prescriptions, aiming to make the application and management of formulae more
effective, safeguard the vital interests of patients, and promote sustainable development of the
whole industry.
This document specifies rules to encode formulae, and gives specific codes for 1 233 frequently‐used
Formulae (1 165 formulae in Annex B and 68 formulae in Annex C). The criteria for selecting the
formulae are:
[93] [131]
— classic works, such as The Inner Canon of Huangdi (黃帝內經) , Treatise on cold (傷寒論) ,
[98]
Synopsis of Golden Chamber (金匱要略) , treatise on differentiation and treatment of epidemic
[164] [9][10]
febrile disease (溫病條辨) , and Chinese pharmacopoeia ;
— experts’ manuals for tertiary and second‐class hospitals’ evaluation of hospital management by
[13][14]
TCM State Chinese Medicine Administration Bureau ;
— the Acupuncture and Chinese medicine practitioners’ qualification exam guide of the United States
[61]
(Chinese and English) ;
— national project textbooks of Chinese medicine (Version 9): Chinese internal medicine, Surgery of
Chinese medicine, Chinese paediatrics, Chinese gynaecology, and formulae of Chinese
[33][34][35][36][37]
medicine ;
— a complete collection of Chinese famous doctors’ Formulae (9031 in total), Traditional Chinese
[63]
formula dictionary (11 volumes in total), and Traditional Chinese medicine dictionary .
© ISO 2018 – All rights reserved v

INTERNATIONAL STANDARD ISO 20334:2018(E)

Traditional Chinese Medicine — Coding system of formulae
1 Scope
This document specifies rules to encode formulae, and gives specific codes for 1 233 frequently‐used
formulae. Chinese patent medicines (CPM) are outside the scope of this document. Kampo formulae are
outside of the scope of this document.
This document is applicable to formula‐relating databases in fields of clinical medication, scientific
research and teaching, electronic medical records and prescription of traditional Chinese medicine
(TCM).
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/IEC 15420, Information technology — Automatic identification and data capture techniques —
EAN/UPC bar code symbology specification
ISO 18668‐1:2016, Traditional Chinese medicine — Coding system for Chinese medicines — Part 1: Coding
rules for Chinese medicines
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
formula
TCM formula
specified prescriptions and preparations which consist of certain kinds of Chinese medicines based on
pattern differentiation, disease differentiation, and treatment methods of traditional Chinese medicine,
by principles of formulating prescriptions and structure
3.2
layer
code layer
set of the characters within the code
EXAMPLE A sub‐field within the code.
[SOURCE: ISO 18668‐1:2016, 3.5, modified]
© ISO 2018 – All rights reserved 1

3.3
Four-Constitution Medicine
Sasang Constitutional Medicine
medicine initiated by Lee Je‐ma, which stresses the theory of the four constitutions: physiology,
pathology, diagnosis, and maintenance of health
[SOURCE: World Health Organization 2007: WHO International Standard Terminologies on Traditional
Medicine in the Western Pacific Region, 0.0.33]
3.4
greater yang person
Tae-yang person
Tai-yang person
one who has strong lung and weak liver in the context of Four‐Constitution Medicine
[SOURCE: World Health Organization 2007: WHO International Standard Terminologies on Traditional
Medicine in the Western Pacific Region, 0.0.35]
3.5
lesser yang person
So-yang person
Shao-yang person
one who has strong spleen and weak kidney in the context of Four‐Constitution Medicine
[SOURCE: World Health Organization 2007: WHO International Standard Terminologies on Traditional
Medicine in the Western Pacific Region, 0.0.36]
3.6
greater yin person
Tae-eum person
Tai-yin person
one who has strong liver and weak lung in the context of Four‐Constitution Medicine
[SOURCE: World Health Organization 2007: WHO International Standard Terminologies on Traditional
Medicine in the Western Pacific Region, 0.0.37]
3.7
lesser yin person
So-eum person
Shao-yin person
one who has strong kidney and weak spleen in the context of Four‐Constitution Medicine
[SOURCE: World Health Organization 2007: WHO International Standard Terminologies on Traditional
Medicine in the Western Pacific Region, 0.0.38]
4 Coding principles
4.1 Uniqueness
Each formula corresponds to a unique code.
4.2 Scalability
The coding rules allow sufficient space for expansion.

4.3 Stability
The code for each formula remains unchanged once assigned, as long as the basic characteristic of the
formula does not change. Even if some formulae are discontinued for use, their codes should still be
kept.
5 Coding technology
5.1 Structure
Formulae are classified according to action. The structure consists of seven layers, with 10 Arabic digits
in total, as shown in Figure 1.

Figure 1 — Coding structure of formulae
5.2 Detailed description
5.2.1 Layer 1
Layer 1 is in categories of agriculture, forestry, pasture husbandry, fishery and Chinese medicines;
...