Health informatics -- Categorial structure for Chinese materia medica products manufacturing process

This document specifies the whole manufacturing process of Chinese materia medica products by defining a set of domain constraints of sanctioned characteristics, each composed of a relationship and an applicable categorial structure. It includes three process categories: processing, extracting and preparation. This document is not applicable to Japanese traditional KAMPO medicinal products.

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Status
Published
Publication Date
07-Jan-2020
Current Stage
6060 - International Standard published
Start Date
13-Dec-2019
Completion Date
08-Jan-2020
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ISO/TS 23303:2020 - Health informatics -- Categorial structure for Chinese materia medica products manufacturing process
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TECHNICAL ISO/TS
SPECIFICATION 23303
First edition
2020-01
Health informatics — Categorial
structure for Chinese materia medica
products manufacturing process
Reference number
ISO/TS 23303:2020(E)
ISO 2020
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ISO/TS 23303:2020(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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ii © ISO 2020 – All rights reserved
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ISO/TS 23303:2020(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 .......................................................................................................................................................................................... 5

4.1 Overview ...................................................................................................................................................................................................... 5

4.2 Semantic link ............................................................................................................................................................................................ 6

4.2.1 Use ................................................................................................................................................................................................ 6

4.2.2 Is processed by .................................................................................................................................................................. 6

4.2.3 Produce .................................................................................................................................................................................... 6

4.2.4 Precede ..................................................................................................................................................................................... 7

4.2.5 Affect .......................................................................................................................................................................................... 7

4.2.6 Result in ................................................................................................................................................................................... 7

4.2.7 Enhance ................................................................................................................................................................................... 7

4.2.8 Reduce .................. .................................................... ................................................................................................................. 7

Bibliography ................................................................................................................................................................................................................................ 8

© ISO 2020 – All rights reserved iii
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ISO/TS 23303:2020(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 23303:2020(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.

The manufacturing process of traditional Chinese materia medica products is a complicated control

system engineering including equipment, technology and quality. The manufacturing process proposed

in this document is a part of traditional Chinese materia medica control system engineering.

There are many types of manufacturing process, but systematic terminology definitions and semantic

links did not exist, which often caused difficulties for production management and metadata analysis.

This arises from two reasons: firstly, a wide variety of dosage forms and manufacturing process are

difficult to classify accurately; secondly, the categorial structure of processing Chinese materia medica

has not been published.

This document provides a categorial structure which could solve these problems and improve the

scientific level of production management of Chinese medicines.
© ISO 2020 – All rights reserved v
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TECHNICAL SPECIFICATION ISO/TS 23303:2020(E)
Health informatics — Categorial structure for Chinese
materia medica products manufacturing process
1 Scope

This document specifies the whole manufacturing process of Chinese materia medica products by

defining a set of domain constraints of sanctioned characteristics, each composed of a relationship

and an applicable categorial structure. It includes three process categories: processing, extracting and

preparation.

This document is not applicable to Japanese traditional KAMPO medicinal products.

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
unit of knowledge created by a unique combination of characteristics (3.1.4)

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 (3.1.4)

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, there is a

relation 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
categorial structure

minimal set of domain constraints for representing concept systems in a subject field

3.1.4
characteristic
abstraction of a property, of an object or of a set of objects
EXAMPLE Fever is a characteristic symptom of flu.
© ISO 2020 – All rights reserved 1
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ISO/TS 23303:2020(E)

Note 1 to entry: Characteristics are used for describing concepts and for differentiating categories.

3.1.5
semantic link

formal representation of a directed associative relation or partitive relation between two concepts (3.1.1)

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 17115:2007, 2.2.3, modified — Note 3 to entry was removed.]
3.1.6
Chinese medicines

substance or combination of substances used under the guidance of traditional Chinese medicine

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 20333:2017, 3.1]
3.1.7
manufacturing

complete process of production through all processing stages, including final packaging, and all

materials involved in the process
3.1.8
product

thing or material manufactured from all processing stages of manufacturing (3.1.7)

Note 1 to entry: Chinese materia medica manufacturing products includ
...

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