ISO/TS 23303:2020

TECHNICAL ISO/TS
SPECIFICATION 23303
First edition
2020-01
Health informatics — Categorial
structure for Chinese materia medica
products manufacturing process
Reference number
©
ISO 2020
© ISO 2020
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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
Foreword
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iv © ISO 2020 – All rights reserved

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.
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.
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
...