ISO/TS 5044:2023

ISO/DTS 5044:2022(E)
Date: 2022-10-31
ISO TC/SC N 215
Secretariat: ANSI
Health informatics –— Information model of representation for quality control of
traditional Chinese medicinal products

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ISO/DTS 5044:2022(E)

DTS- stage
© ISO 20142022
All rights reserved. Unless otherwise specified, 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
Case postale 56 •• CH-1211 Geneva 20
Tel. + 41 22 749 01 11
Fax + 41 22 749 09 47
E-mail copyright@iso.org
Web www.iso.org www.iso.org
Published in Switzerland.
ii © ISO 2022 – All rights reserved

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ISO/DTS 5044:2022(E)
Contents
Foreword . 5
Introduction . 6
1 Scope . 7
2 Normative references . 7
3 Terms and definitions . 7
4 Semantic links for quality control of traditional Chinese medicinal products . 13
5 Information model for quality control of traditional Chinese medicinal products . 14
Bibliography . 16
© ISO DTS 5044 – All rights reserved © ISO 2022 – All iii
rights reserved

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ISO/DTS 5044:2022(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 onof 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.htmlthe following URL: .
This document was prepared by Technical Committee ISO/TC 215, Health informatics, in collaboration
with 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.htmlThe committee responsible for
this document is ISO/TC 215.

iv © ISO 2022 – All rights reserved

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ISO/DTS 5044:2022(E)
.
© ISO DTS 5044 – All rights reserved © ISO 2022 – All v
rights reserved

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ISO/DTS 5044:2022(E)
Introduction
Chinese materia medica, especially traditional Chinese medicinal products are widely utilized as a part of
complementary and alternative medicine throughout East Asia and western countries. In order to
guarantee the quality and therapeutic effecteffects, quality control of traditional Chinese medicinal
products is very significant and valuable.
Quality control of traditional Chinese medicinal products is very difficult. This arises foris due to five main
reasons as follows: firstly, a wide variety of dosage formforms and the manufacturing processprocesses
are difficult to accurately classified；classify; secondly, the influencing factors in the manufacturing
process are very complicated, which are difficult to be accurately described and controlled; thirdly, thean
information model of the preparation of Chinese materia medica has not been described and published;
fourthly, the therapeutic effect of Chinese medicine is the comprehensive result of multi-component
material basis inbased on biological metabolism engineering, and the quality control technology of
Chinese medicine is often unable to meet the practical needs due to its complex mechanism; fifthly, the
requirements for quality control of traditional Chinese medicinal products and relevant regulations vary
greatly from country to country, resulting in various and inconsistent standards of for traditional Chinese
medicinal products and the inability to achieve drug circulation and resource sharing.
The wide range of disciplines and the individualities ofspecific national usages have led to different
meanings being attributed to particular terms and different terms being used to describe the same
concept. To avoid the consequent misunderstandings and to facilitate the exchange of information, it is
essential to clarify the concepts, to establish the correct terms for use, and to establish their definitions.
This document defines the
vi © ISO 2022 – All rights reserved

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ISO/DTS 5044:2022(E)
Health informatics — Information model of representation for quality control of traditional
Chinese medicinal products.

© ISO DTS 5044 – All rights reserved © ISO 2022 – All vii
rights reserved

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ISO/DTS 5044:2022(E)
Health Informatics — Information model of representation for quality
control of traditional Chinese medicinal products
1 1 Scope

This document specifies an information model of representation forrepresenting the quality control of
the manufacturing process of traditional Chinese medicinal products by defining a set of domain
constraints of sanctioned characteristics, each composed of a relationship and an applicable information
model in order to represent the quality control of manufacturing process of Chinese materia medica. .
It is applicable to the quality supervision and management of manufacturing process of Chinese materia
medica.
Japanese KAMPO medicine is out ofoutside the scope.
of this document.
2 2 Normative references
The following documents, in whole or in part, are normatively referenced in this document and are indispensable
for its application. For dated references, only the edition cited applies. For undated references, the latest edition
of the referenced document (including any amendments) applies.
ISO 17115, Health informatics — Vocabulary for terminological systems
ISO 18668-1:2016(en)Traditional Chinese medicine -- Coding system for Chinese medicines — Part 1: Coding
rules for Chinese medicines
ISO 18668-2:2017 Traditional Chinese medicine -- Coding system for Chinese medicines -- Part 2: Codes for
decoction pieces.
3 There are no normative references in this document.
3 Terms and definitions
For the purposes of this document, the following terms and definitions apply.
ISO and IEC maintain terminologicalterminology databases for use in standardization at the following
addresses. :
IEC Electropedia: available at — ISO Online browsing platform: available at https://www.iso.org/obp

3.1 — IEC Electropedia: available at https://www.electropedia.org/
3.1 General
3.1.1
concept
unit of knowledge created by a unique combination of characteristics
Note 1 to entry: A concept can have one or more names. It can be represented using one or more terms, pictures,
icons or sounds.
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ISO/DTS 5044:2022(E)
3.1.2
category
division of sets of entities regarded as having particular shared characteristics
EXAMPLE: Freeze drying, spray drying and all other drying share characteristics particular to the category drying.
Note 1 to entry: Categories maycan be more or less general. Where one category is subsumed by another, there is a
relation is asserted to obtain a hierarchy between the more specific or subsumed category and the more general or
subsuming category. For example, "parenteral route" is more general than "intravenous route.".
3.1.3
information model
graphical and textual representation of entities and the relationships between them
Note 1 to entry: Can also be known as a data model, a conceptual data model, a logical data model, an entity
relationship model, an object class diagram, or a database definition.
[SOURCE: ISO/IEC 19763-12: 2015, 4.2.24]
3.1.4
characteristic
abstraction of a property of an object or of a set of objects
EXAMPLE ：Fever is a characteristic symptom of the flu.
Note 1 to entry: Characteristics are used for describing concepts (3.1.1) and for differentiating categories (3.1.2).
3.1.5
semantic link
formal representation of a directed associative relation or partitive relation between two concepts
Example: Is cause of (with inverse has cause); has Location (with inverse is Location Of).
Note 1 to entry: This includes all relations except the generic relation.
Note 2 to entry: A semantic link always has an inverse, i.e. another semantic link with the opposite direction.
[SOURCE: ISO 17115:2020, 3.2.5, modified, example — Example has been changed].]
3.1.6
Chinese medicine
substance or combination of substances used under the guidance of traditional Chinese medicine (TCM)
theory for medical care and the prevention and treatment of disease
Note 1 to entry: This includes Chinese materia medica, decoction pieces, granule forms of individual medicinals for
prescriptions (GFIMP),) and Chinese patent medicines (CPM).
[SOURCE: ISO 18668-1:2016, 3.1]
3.2 3.2 Characterizing categories
3.2.1
chemical analysis
qualitative and quantitative analysis based on the chemical reactions of substances
© ISO DTS 5044 – All rights reserved © ISO 2022 – All ix
rights reserved

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ISO/DTS 5044:2022(E)
EXAMPLE ：HPLC, MS, NMR, IR, UV, GC, CE and other combined techniques were used for the quantitative
determination of active ingredients or index components
3.2.2
bioanalysis
analysis of the biological activity (including efficacy and toxicity) of drugs using organisms including
whole animals, in vitro tissues, organs, cells and microorganisms
3.2.3
character analysis
a simple physical and chemical test method is used to distinguish the true and the false by the apparent
characters of the objects
3.2.4
impurity
a substance that has no therapeutic effect andor damages to the body
3.2.5
effective constituent
chemical constituents of Chinese materia medica, intermediates and Chinese patent medicine that have
the efficacyare efficacious
3.2.6
endogenous toxic component
a substance in medicine that causes adverse effects and damage to the body
3.2.7
exogenous harmful substance
harmful ingredients in medicine including pesticide residue, heavy metals and so on, etc.
3.2.8
heavy metalsmetal
metal usually of relatively high density, atomic weight, or atomic number
Note 1 to entry: In metallurgy, for example, a heavy metal maycan be defined on the basis of density, whereas in
physics, the distinguishing criterion mightcan be the atomic number, while a chemist would likely be more
concerned with chemical behaviour. More specific definitions have been published, but none of these have been
widely accepted. A density of more than 5 g/cm3 is sometimes quoted as a commonly used criterion.
EXAMPLE: Pb, Hg, Bi, As, Ti, Sn, Cd, Ag, Cu and Mo.
3.2.9
pesticide residue
chemical agent that remains in organisms, harvests, soil, water, pesticide progenitor in the atmosphere,
toxic metabolites, degradation products and impurities
3.2.10
microbiolo
...

FINAL
TECHNICAL ISO/DTS
DRAFT
SPECIFICATION 5044
ISO/TC 215
Health informatics — Information
Secretariat: ANSI
model for quality control of traditional
Voting begins on:
2022-12-12 Chinese medicinal products
Voting terminates on:
2023-02-06
Member bodies are requested to consult relevant national interests in ISO/TC
249 before casting their ballot to the e-Balloting application.
RECIPIENTS OF THIS DRAFT ARE INVITED TO
SUBMIT, WITH THEIR COMMENTS, NOTIFICATION
OF ANY RELEVANT PATENT RIGHTS OF WHICH
THEY ARE AWARE AND TO PROVIDE SUPPOR TING
DOCUMENTATION.
IN ADDITION TO THEIR EVALUATION AS
Reference number
BEING ACCEPTABLE FOR INDUSTRIAL, TECHNO-
ISO/DTS 5044:2022(E)
LOGICAL, COMMERCIAL AND USER PURPOSES,
DRAFT INTERNATIONAL STANDARDS MAY ON
OCCASION HAVE TO BE CONSIDERED IN THE
LIGHT OF THEIR POTENTIAL TO BECOME STAN-
DARDS TO WHICH REFERENCE MAY BE MADE IN
NATIONAL REGULATIONS. © ISO 2022

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ISO/DTS 5044:2022(E)
FINAL
TECHNICAL ISO/DTS
DRAFT
SPECIFICATION 5044
ISO/TC 215
Health informatics — Information
Secretariat: ANSI
model for quality control of traditional
Voting begins on:
Chinese medicinal products
Voting terminates on:
Member bodies are requested to consult relevant national interests in ISO/TC
249 before casting their ballot to the e­Balloting application.
COPYRIGHT PROTECTED DOCUMENT
© ISO 2022
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.
RECIPIENTS OF THIS DRAFT ARE INVITED TO
ISO copyright office
SUBMIT, WITH THEIR COMMENTS, NOTIFICATION
OF ANY RELEVANT PATENT RIGHTS OF WHICH
CP 401 • Ch. de Blandonnet 8
THEY ARE AWARE AND TO PROVIDE SUPPOR TING
CH-1214 Vernier, Geneva
DOCUMENTATION.
Phone: +41 22 749 01 11
IN ADDITION TO THEIR EVALUATION AS
Reference number
Email: copyright@iso.org
BEING ACCEPTABLE FOR INDUSTRIAL, TECHNO­
ISO/DTS 5044:2022(E)
Website: www.iso.org
LOGICAL, COMMERCIAL AND USER PURPOSES,
DRAFT INTERNATIONAL STANDARDS MAY ON
Published in Switzerland
OCCASION HAVE TO BE CONSIDERED IN THE
LIGHT OF THEIR POTENTIAL TO BECOME STAN­
DARDS TO WHICH REFERENCE MAY BE MADE IN
ii
  © ISO 2022 – All rights reserved
NATIONAL REGULATIONS. © ISO 2022

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ISO/DTS 5044:2022(E)
Contents Page
Foreword .iv
Introduction .v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
3.1 General . 1
3.2 Characterizing categories . 2
4 Categorial structure . 6
4.1 Information model for quality control of traditional Chinese medicinal products . 6
4.2 Semantic link . 8
4.2.1 measure . 8
4.2.2 consist of . 8
4.2.3 characterize . 8
4.2.4 affect . 8
4.2.5 be processed into . 8
4.2.6 have attribute of . 8
4.2.7 include . . 8
4.2.8 evaluate . 9
Bibliography .10
iii
© ISO 2022 – All rights reserved

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ISO/DTS 5044:2022(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 non­governmental, 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 215, Health informatics, in collaboration
with 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 2022 – All rights reserved

---------------------- Page: 4 ----------------------
ISO/DTS 5044:2022(E)
Introduction
Chinese materia medica, especially traditional Chinese medicinal products are widely utilized as a part
of complementary and alternative medicine throughout East Asia and western countries. In order to
guarantee quality and therapeutic effects, quality control of traditional Chinese medicinal products is
very significant and valuable.
Quality control of traditional Chinese medicinal products is very difficult. This is due to five main
reasons: firstly, a wide variety of dosage forms and the manufacturing processes are difficult to
accurately classify; secondly, the influencing factors in the manufacturing process are very complicated,
which are difficult to be accurately described and controlled; thirdly, an information model of the
preparation of Chinese materia medica has not been described and published; fourthly, the therapeutic
effect of Chinese medicine is the comprehensive result of multi­component material based on biological
metabolism engineering, and the quality control technology of Chinese medicine is often unable to
meet the practical needs due to its complex mechanism; fifthly, the requirements for quality control of
traditional Chinese medicinal products and relevant regulations vary greatly from country to country,
resulting in various and inconsistent standards for traditional Chinese medicinal products and the
inability to achieve drug circulation and resource sharing.
The wide range of disciplines and the specific national usages have led to different meanings being
attributed to particular terms and different terms being used to describe the same concept. To avoid
the consequent misunderstandings and to facilitate the exchange of information, it is essential to clarify
the concepts, to establish the correct terms for use, and to establish their definitions.
v
© ISO 2022 – All rights reserved

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TECHNICAL SPECIFICATION ISO/DTS 5044:2022(E)
Health informatics — Information model for quality
control of traditional Chinese medicinal products
1 Scope
This document specifies an information model representing the quality control of the manufacturing
process of traditional Chinese medicinal products by defining a set of domain constraints of sanctioned
characteristics, each composed of a relationship.
It is applicable to the quality supervision and management of manufacturing process of Chinese materia
medica.
Japanese KAMPO medicine is outside the scope of this document.
2 Normative references
There are no normative references in this document.
3 Terms and definitions
For the purposes of this document, the following terms and definitions apply.
ISO and IEC maintain terminology databases for use in standardization at the following addresses:
— ISO Online browsing platform: available at https:// www .iso .org/ obp
— IEC Electropedia: available at https:// www .electropedia .org/
3.1 General
3.1.1
concept
unit of knowledge created by a unique combination of characteristics
Note 1 to entry: A concept can have one or more names. It can be represented using one or more terms, pictures,
icons or sounds.
3.1.2
category
division of sets of entities regarded as having particular shared characteristics
EXAMPLE Freeze drying, spray drying and all other drying share characteristics particular to the category
drying.
Note 1 to entry: Categories can be more or less general. Where one category is subsumed by another, a relation
is asserted to obtain a hierarchy between the more specific or subsumed category and the more general or
subsuming category. For example, "parenteral route" is more general than "intravenous route".
3.1.3
information model
graphical and textual representation of entities and the relationships between them
Note 1 to entry: Can also be known as a data model, a conceptual data model, a logical data model, an entity
relationship model, an object class diagram, or a database definition.
[SOURCE: ISO/IEC 19763­12: 2015, 4.2.24]
1
© ISO 2022 – All rights reserved

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ISO/DTS 5044:2022(E)
3.1.4
characteristic
abstraction of a property of an object or of a set of objects
EXAMPLE Fever is a characteristic symptom of the flu.
Note 1 to entry: Characteristics are used for describing concepts (3.1.1) and for differentiating categories (3.1.2).
3.1.5
semantic link
formal representation of a directed associative relation or partitive relation between two concepts
EXAMPLE Is cause of (with inverse has cause); has Location (with inverse is Location Of).
Note 1 to entry: This includes all relations except the generic relation.
Note 2 to entry: A semantic link always has an inverse, i.e. another semantic link with the opposite direction.
[SOURCE: ISO 17115:2020, 3.2.5, modified — Example has been changed.]
3.1.6
Chinese medicine
substance or combination of substances used under the guidance of traditional Chinese medicine (TCM)
theory for medical care and the preventi
...