Information model of Chinese materia medica processing

This document specifies an information model within the field of Chinese materia medica processing. It defines a set of domain constraints of sanctioned characteristics, each composed of a relationship and an applicable information model. This model aims at representing the concepts applicable to Chinese materia medica processing in the making of decoction pieces. This document is not applicable to Japanese traditional Kampo medicine.

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Status
Published
Publication Date
19-Jan-2020
Current Stage
6060 - International Standard published
Start Date
10-Dec-2019
Completion Date
20-Jan-2020
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ISO/TS 21831:2020 - Information model of Chinese materia medica processing
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TECHNICAL ISO/TS
SPECIFICATION 21831
First edition
2020-01
Information model of Chinese materia
medica processing
Reference number
ISO/TS 21831:2020(E)
ISO 2020
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ISO/TS 21831:2020(E)
COPYRIGHT PROTECTED DOCUMENT
© ISO 2020

All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may

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Published in Switzerland
ii © ISO 2020 – All rights reserved
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ISO/TS 21831:2020(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 Overview ...................................................................................................................................................................................................... 6

4.2 Semantic link ............................................................................................................................................................................................ 8

Bibliography .............................................................................................................................................................................................................................10

© ISO 2020 – All rights reserved iii
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ISO/TS 21831:2020(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 215, Health informatics.

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 2020 – All rights reserved
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ISO/TS 21831:2020(E)
Introduction

Chinese materia medica is widely utilized as a part of complementary and alternative medicine

throughout East Asia and western countries. In order to ensure the quality and therapeutic effect of

Chinese medicines, it is important to use a proper manufacturing process of Chinese materia medica.

There are guidelines for processing Chinese materia medica in the Traditional Chinese Medicine

industry, and clinical trials are already available. A large number of relevant trials have been conducted

to assess the function of decoction pieces of Chinese materia medica. However, the descriptions of

processing in reports tend to be insufficient for the interpretation of heterogeneity among trials, often

causing difficulties for data synthesis in meta-analyses. This arises from two reasons: firstly, because

of the lack of use of an appropriate information model of the processing of Chinese materia medica, and

secondly because semantic associations between concepts of Chinese materia medica processing have

yet to be explicitly identified.

In order to address these problems, this document defines the information model within the field of

Chinese materia medica processing.
© ISO 2020 – All rights reserved v
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TECHNICAL SPECIFICATION ISO/TS 21831:2020(E)
Information model of Chinese materia medica processing
1 Scope

This document specifies an information model within the field of Chinese materia medica processing. It

defines a set of domain constraints of sanctioned characteristics, each composed of a relationship and

an applicable information model.

This model aims at representing the concepts applicable to Chinese materia medica processing in the

making of decoction pieces.
This document is not applicable to Japanese traditional Kampo medicine.
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 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 General
3.1.1
concept
internal conception of some thing; general notion or idea of some thing
[SOURCE: ISO/TS 18876-2:2003, 3.1.3]
3.1.2
entity
any concrete or abstract thing of interest
3.1.3
relationship

association between two or more entities (3.1.2) indicating the purpose or type of association

Note 1 to entry: Can also be known as an association when the information model is based upon object classes.

3.1.4
information model

graphical and textual representation of entities (3.1.2) and the relationships (3.1.3) 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]
© ISO 2020 – All rights reserved 1
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ISO/TS 21831:2020(E)
3.2 Characterizing categories
3.2.1
traditional Chinese medicine
TCM

traditional medicine that originated in China, and is characterized by holism and treatment based on

pattern identification/syndrome differentiation
[SOURCE: ISO/TS 17948:2014, 2.2]
3.2.2
Chinese materia medica
CMM

medicinal parts of medicinal plants, animals, and minerals after preliminary processing (3.2.4), which

are used as raw materials in Chinese medicines
Note 1 to entry: This refers to the raw materials used to make decoction pieces.
[SOURCE: ISO 18668-1:2016, 3.2]

Note 2 to entry: Preliminary processing can include washing and drying. Large and bulking items can also be cut

into smaller pieces or shorter lengths.
3.2.3
decoction piece

prescription medicine processed from Chinese materia medica (3.2.2) under the direction of traditional

Chinese medicine (3.2.1) and processing (3.2.4) methods for Chinese medicines, which can be directly

used in clinical practice or the production of prepared medicines
3.2.4
processing

physical or chemical technique of converting Chinese materia medica (3.2.2) into decoction pieces

(3.2.3) based on the theory of pharmacology of traditional Chinese medicine (3.2.1), the nature of Chinese

materia medica (3.2.30), the need for dispensing, preparation (3.2.19) and clinical application

Note 1 to entry: This definition is taken from Reference [24].
3.2.5
toxicity
ability of a substance to produce an adverse effect upon a living organism
[SOURCE: ISO 472:2013, 2.767]
3.2.6
effectiveness
accuracy and completeness with which users achieve specified goals
[SOURCE: ISO/TS 20282-2:2013, 4.7]
3.2.7
adjuvant material

substance added during processing (3.2.4) in order to enhance the therapeutic usefulness of

pharmaceutical herbal medicament treatment

Note 1 to entry: Adjuvant material is different from excipient material. The latter is usually used to produce pills

or tablets, inseparable from tablets, etc. But the solid adjuvant material is discarded after processing.

[SOURCE: ISO/TS 18062:2016, 3.4, modified — Note to entry has been modified.]
2 © ISO 2020 – All rights reserved
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ISO/TS 21831:2020(E)
3.2.8
channel tropism
meridian tropism

orientation of the medicinal action according to the meridian/channel on which the therapeutic action

is manifested
Note 1 to entry: This definition is taken from Reference [20].
3.2.9
moisture content
amount of water contained in decoction pieces (3.2.3) after processing (3.2.4)

Note 1 to entry: General moisture content of CMM and decoction shall be controlled between 7 % and 13 %.

Note 2 to entry: This definition is taken from Reference [22].
3.2.10
ash content

basic purity (3.2.12) indicator for the quality control of decoction pieces (3.2.3)

Note 1 to entry: Ash is present in the residue weight of decoction pieces left after incineration at high temperature

(500℃ to 600℃).

Note 2 to entry: Ash content including physiological ash and acid incompatibility ash.

EXAMPLE The total ash content of GLYCYRRHIZAE RADIX ET RHIZOMA (Gancao) is not more than 7 %. The

acid incompatibility ash content is not more than 2 %.
Note 3 to entry: This definition is taken from Reference [22].
3.2.11
texture
shape, size, colour, quality of the herb and decoction pieces (3.2.3)
Note 1 to entry: This definition is taken from Reference [23].
3.2.12
purity

quota of the impurities or non-medicinal parts in processed Chinese materia medica (3.2.2)

Note 1 to entry: This definition is taken from Reference [22].
3.2.13
pressure
exertion of force upon a surface
3.2.14
decoction ingredient

chemical components including bioactive or therapeutic agents, and other invalid chemical constituents

in decoction pieces (3.2.3) which stem from botanical medicine (3.2.16), mineral medicine (3.2.17) and

animal medic
...

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