ISO/TS 18062:2016
(Main)Health informatics — Categorial structure for representation of herbal medicaments in terminological systems
Health informatics — Categorial structure for representation of herbal medicaments in terminological systems
ISO/TS 18062:2016 aims to a) specify the minimal characterizing generic concepts in herbal medicament (3.2) within terminological systems (3.8), that are required for terms used to identify of herbal medicines regulated by medicine regulatory agencies (3.10), and b) facilitate the consistency and interoperability of the terms and their designating concepts in terminological systems. In order to achieve these goals, this document specifies the minimal compositional concept representation of herbal medicament for use in terminological systems (3.8), while expressing semantic links and characterizing categories for formal definitions, with a set of domain constraints in the subject field[6] [7]. Herbal medicaments (3.2) can be classified into 1) single herbal medicament (SHM), and 2) herbal medicament composed of several kinds of SHM. NOTE Single herbal medicament is composed of only one herbal medicament. Herbal medicament composed of several kinds of SHMs is conventionally called "formula." This document is not intended to include the mixture of formulae. The specific intended use of this compositional concept representation is to - provide a well-structured backbone for terminological systems, - clarify the synonymy, homonymy and polysemy across different clinical specialties and terminological resources, - promote meaningful exchange of information among different terminological systems, - promote consistency and interoperability or re-use of terms among different terminological systems, - facilitate the representation of herbal medicines in a manner suitable for computer processing, - support developers and maintainers of terminological resources (3.7) to facilitate conformance, - support knowledge management on herbal medicines with facilitating analysis of concerned data, and - support the reduction of confusion in trade and of health hazard in consequence. The following topics are out of scope for this document: - any implementation models or database schemas, and manufacturing models; - any models or frameworks for quality control, and models for chemical and physical characteristics; - any individual pharmaceutical or medicinal products, and combinations use with modern medicines.
Informatique de santé — Structure catégorielle pour la représentation de médicaments à base de plantes dans les systèmes terminologiques
General Information
Standards Content (Sample)
TECHNICAL ISO/TS
SPECIFICATION 18062
First edition
2016-12-15
Health informatics — Categorial
structure for representation
of herbal medicaments in
terminological systems
Informatique de santé — Structure catégorielle pour la
représentation de médicaments à base de plantes dans les systèmes
terminologiques
Reference number
©
ISO 2016
© ISO 2016, Published in Switzerland
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ii © ISO 2016 – All rights reserved
Contents Page
Foreword .iv
Introduction .v
1 Scope . 1
2 Normative references . 2
3 Terms and definitions . 2
4 Abbreviated terms . 4
5 Single herbal medicament (SHM) . 4
5.1 Overview . 4
5.2 Characterizing categories . 6
5.2.1 Origin . 6
5.2.2 PartOfInterest . 6
5.2.3 Processing . 7
5.3 Semantic links . 7
5.3.1 isMadeOf . 7
5.3.2 isPartOf . 8
5.3.3 isProcessedBy . . 8
5.3.4 isFollowedBy . 8
5.3.5 isMadeBy . 8
6 Herbal medicament composed of SHMs . 9
6.1 Overview . 9
6.2 Characterizing categories . 9
6.2.1 Required SHM . 9
6.2.2 Amount .10
6.3 Semantic links .11
6.3.1 isComposedOf.11
6.3.2 with . .11
7 Conformity .11
Annex A (informative) Commentary on the high level terms and concepts in categorial structure 12
Annex B (informative) Terms mapping between IDMPs .15
Bibliography .17
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
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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
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Attention is drawn to the possibility that some of the elements of this document may be the subject of
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The committee responsible for this document is ISO/TC 215, Health informatics.
iv © ISO 2016 – All rights reserved
Introduction
Medicinal or pharmaceutical products (3.11, 3.12) derived from plants have complicated backgrounds
and a wide range of uses in traditional and western medicine.
Medicinal plants contain many constituent substances and the content of these substances differ
throughout parts of some plants. Medicinal plants may be used individually or in combination with
[32]–[63]
other medicinal plants . The combination of medicinal plants and the rules and methods used
to achieve this combination is conventionally called a “formula.” The constituents of formulas are
determined by the species of the source materials, which parts of the plants are used, and the quantity
of each source material used. The quantity of active substances used directly influences the efficacy
and side effects of herbal medicines.
A medicine regulatory agency (3.10) controls pharmacopoeias that define the “requisites” for each
herbal pharmaceutical and/or medicinal product and the “name” by which the product is to be referred.
It should be noted that a pharmacopoeia does not define a product itself, but rather its “design” under its
“common name.” In other words, pharmacopoeias define “a set of concepts” with a “common name” and
regulate the fundamental characteristics of a certain group of pharmaceutical or medicinal products.
However, there are many synonyms, homonyms and polysemes used in pharmacopoeias: the same species
of source material is often represented by different expressions, and vice versa. In addition, a single
[28]–[30],
“common name” often designates different compositions of formulas in different pharmacopoeias
[52]–[63]
. Disagreement on the definitions of “sets of concepts” and “common names” of herbal medicines
[10]
in various terminological resources (3.7) have caused confusion in international trade which increases
risk of harm to patients and negative impact to scientific research including clinical tests.
This problem should be resolved by standardization, while according respect to each pharmacopoeia
[2]
and avoiding market distortion. ISO 860 has already proposed an approach to this issue in preparing
the harmonization of necessary concepts before “term standardization.” This approach implicitly
requires the prior building of a well-structured backbone, i.e. “a set of concepts” for terms. For this
[4] –[7]
purpose, ISO 1087-1, EN 12264 and ISO 17115 define the structures of concepts and provide the
necessary terms that designate the elements of concept structures. This framework is called “categorial
structure.”
This document uses a categorial structure to represent the concepts required in order to contribute
to both international harmonization and supporting the ability to map with appropriate semantic
correspondence between the terms on herbal medicines in various pharmacopoeias. Please refer to
ISO 17115:2007, Annex A, as well as ISO 1087-1.
This document provides initial guidance to those developing and implementation systems to represent
herbal medicaments. Users should understand that this work has identified several issues, which
require further investigation in order to develop a future International Standard:
— need to clarify and describe the relationship of the concepts described in the categorial structure to
existing standards including IDMP; where there are differences, ISO 11238 IDMP should be followed;
— definitions used in this document are those used in some cultures, countries and areas of clinical
practice (e.g. traditional medicine) which use words differently to that of IDMP (see Annex B);
— these variations may also arise from the focus on terminological and ontological specifications
rather than pharmaceutical concepts; there is a recognized need to undertake further work to
clarify these definitions and to identify where there is
— more than one term is used to describe a single thing and agree on synonyms or preferred terms,
— single term used with different meanings in different contexts, and
— a need to define a term or concept not currently defined or confusing, e.g. active substance,
herbal substance, botanical substance, source material and source;
— the relationship between medicinal regulatory agencies and pharmacopoeia;
— the use of the term concept has been used in this document from a terminological perspective not
from a pharmaceutical one and this requires clarification.
vi © ISO 2016 – All rights reserved
TECHNICAL SPECIFICATION ISO/TS 18062:2016(E)
Health informatics — Categorial structure for
representation of herbal medicaments in terminological
systems
1 Scope
The document aims to
a) specify the minimal characterizing generic concepts in herbal medicament (3.2) within terminological
systems (3.8), that are required for terms used to identify of herbal medicines regulated by medicine
regulatory agencies (3.10), and
b) facilitate the consistency and interoperability of the terms and their designating concepts in
terminological systems.
In order to achieve these goals, this document specifies the minimal compositional concept representation
of herbal medicament for use in terminological systems (3.8), while expressing semantic links and
[6] [7]
characterizing categories for formal definitions, with a set of domain constraints in the subject field .
Herbal medicaments (3.2) can be classified into
1) single herbal medicament (SHM), and
2) herbal medicament composed of several kinds of SHM.
NOTE Single herbal medicament is composed of only one herbal medicament. Herbal medicament composed
of several kinds of SHMs is conventionally called “formula.” This document is not intended to include the mixture
of formulae.
The specific intended use of this compositional concept representation is to
— provide a well-structured backbone for terminological systems,
— clarify the synonymy, homonymy and polysemy across different clinical specialties and
terminological resources,
— promote meaningful exchange of information among different terminological systems,
— promote consistency and interoperability or re-use of terms among different terminological
systems,
— facilitate the representation of herbal medicines in a manner suitable for computer processing,
— support developers and maintainers of terminological resources (3.7) to facilitate conformance,
— support knowledge management on herbal medicines with facilitating analysis of concerned data, and
— support the reduction of confusion in trade and of health hazard in consequence.
The following topics are out of scope for this document:
— any implementation models or database schemas, and manufacturing models;
— any models or frameworks for quality control, and models for chemical and physical characteristics;
— any individual pharmaceutical or medicinal products, and combinations use with modern medicines.
2 Normative references
There are no normative references in this document.
3 Terms and definitions
For the purposes of this document, the terms and definitions given in ISO 1087-1, ISO 17115, EN 12264
and the following apply.
ISO and IEC maintain terminological databases for use in standardization at the following addresses:
— IEC Electropedia: available at http://www.electropedia.org/
— ISO Online browsing platform: available at http://www.iso.org/obp
3.1
herbal substance
botanical substance
source material (context: pharmacy)
source (context: pharmacy)
physical matter of the plant used as medicines, including plant, algae, fungi or lichen, used in whole
or in part
Note 1 to entry: In this document, herbal substance (3.1) is used in the meaning of source material. The ingredients
of it are determined by the part(s) of interest (3.3) of an origin.
Note 2 to entry: The definitions of “herbal substance” in E.1.3 (herbal substance), E.1.5 (herbal substance,
according to the pharmacopoeia), E.1.6 (herbal preparation), E.2.1 (European Directives: Article 30, 31, 32)
[26]
and E.2.2 (European Pharmacopoeia) in ISO/TS 19844:2015, Annex E are different from the definition in
this document. The former definitions should be respected when implementing an IDMP family or referring to
European Pharmacopoeia. Where IDMP applies in the jurisdiction, IDMP definitions should be given priority.
3.2
herbal medicament
minimal concepts for representation of regulated design or identification of pharmaceutical products
(3.12) or medicinal products (3.11) made of herbal substance(s) (3.1)
Note 1 to entry: This document does not mention any individual pharmaceutical products (3.12) or medicinal
products (3.11). Herbal medicament (3.2) designates the “design” or the concepts of herbal pharmaceuticals or
medicinal products at an abstract or design level regulated by medicine regulatory agencies (3.10). Pharmacopoeias
defined them with their name, therefore, that are also regulated by medicine regulatory agencies.
Note 2 to entry: This document does not include the mixture of formulas.
3.3
part of interest
medicinal part
partofinterest
part of the plant that is intended for use as a herbal substance (3.1)
EXAMPLE Seed, root, rhizome, stem, bark, leaf, bud, flower, fruit.
3.4
assistant material
adjuvant material
substance added during processing in order to enhance the therapeutic usefulness of pharmaceutical
herbal medicament (3.2) treatment
Note 1 to entry: “Adjuvant” in this context does not mean the adjuvant in modern scientific parlance, rather, is
used to support elution of bioactive substrates, enhancing efficacy and reducing toxicity, flavouring and taste
masking, or as a filler.
2 © ISO 2016 – All rights reserved
EXAMPLE Rice wine, liquor, vinegar, honey.
3.5
value
designation of a characterizing concept as an instance of a concept of a
characterizing category
Note 1 to entry: This definition can be rewritten: designation of an individual concept as a member of the extension
of a generic concept, or accurately, a characterizing generic concept. This term is not explicitly defined both in
either EN 12264 or ISO 17115, but can only be derived speculatively from the relations between terms and
definitions contained therein.
EXAMPLE Number, controlled or regulated vocabulary or code, object identifier, regulated description.
Note 2 to entry: Value domain, i.e. characterizing generic concept or characterizing category is defined as the values
(3.5) shall be allowed to be used in a particular context (3.6). Please also refer to context (3.6) and Annex A.
3.6
context
related conditions and situations that provide a useful understanding and meaning of a subject
Note 1 to entry: ISO 1087-1 also defines this term as “text which illustrates a concept or the use of a designation.”
However, this document adopts the definition in ISO/TR 17119 because of its clear and direct illustration as well
as the fact that it is not limited to text.
Note 2 to entry: Context (3.6) may contain multiple viewpoints according to its definition because the definition
of value domain said in its note that the context includes a superordinate concept and a semantic link. Also, semantic
link means any types of associative relation that includes sequential relation, temporal relation, causal relation, etc.
Please also refer to value (3.5) and Annex A.
[SOURCE: ISO/TR 17119:2005, 2.5 — modified]
3.7
terminological resource
controlled set of terms in healthcare
Note 1 to entry: A terminological resource is usually designed and controlled for use with computers for specific
healthcare purpose such as data entry, aggregation, retrieval and analysis.
[SOURCE: ISO 17117-1:—, 3.4.1]
3.8
terminological system
structured human and machine-readable representation of healthcare concepts and
relationships
Note 1 to entry: Every terminological system shall be at least organized by hierarchical relations.
Note 2 to entry: Every terminological system shall have term representations of healthcare concepts for human-
readability.
Note 3 to entry: Terminological system may have associative relations and definitions.
Note 4 to entry: Terminological system is used directly or indirectly to describe health conditions and healthcare
activities, and allow their subsequent retrieval for analysis.
[SOURCE: ISO 17117-1:—, 3.4.2]
3.9
medical domain
field of action, thought or influence related to the science or practice of medicine or a sub-specialization
of medicine
Note 1 to entry: Medical domain (3.9) can be recognized as a facet of subject field. It provides one of the factors
that compose a context (3.6), and affects the values (3.5) bound to semantic links. See also the examples in 5.1.
Note 2 to entry: Modern medicine is also an instance of a concept of medical domain (3.9) as a characterizing
category.
EXAMPLE Modern medicine, Ayurveda, traditional African medicine, traditional Australian medicine
(Aboriginal), traditional Canadian medicine, Chinese medicine or traditional Chinese medicine, traditional
Japanese medicine (Kampo), traditional Korean, Mongolian, New Zealand (Maori), Thailand, Tibetan, Unani, or
Vietnamese medicine, and so on.
Note 3 to entry: Conceptual representation shall be free from multilingual expressions but medical domain (3.9)
[19] [15]–[22]
would also affect the expressions in a certain script(s) of a language and the related factors .
3.10
Medicine Regulatory Agency
institutional body that, according to the legal system under which it has been established, is responsible
for the granting of marketing authorization for medicinal products (3.11)
[SOURCE: ISO 11615:2012, 3.1.53]
3.11
medicinal product
any substance or combination of substances that may be administered to human beings to treat or
prevent disease
Note 1 to entry: Medical products are used to make a medical diagnosis or to restore, correct or modify
physiological functions
Note 2 to entry: In this document, the scope of medicinal products is generally restricted to human beings. It is
recognized that they could be applied also to animals but this is not the intended scope of this document.
[SOURCE: ISO 11615:2012, 3.1.49 — modified]
3.12
pharmaceutical product
qualitative and quantitative composition of medicinal products (3.11) in the dose form approved for
administration in line with the regulated product information
[SOURCE: ISO 11615:2012, 3.1.58]
4 Abbreviated terms
HM herbal medicament (3.2)
SHM single herbal medicament (3.2)
5 Single herbal medicament (SHM)
5.1 Overview
The single herbal medicament (SHM) is the key component of herbal medications. The diagram below
identifies the characterizing categories, which represent a SHM in terminological systems.
In the compositional concept representation, a single herbal medicament (3.2) has semantic links to the
following characterizing categories: Origin (5.2.1), PartOfInterest (5.2.2) and Processing (5.2.3). These
4 © ISO 2016 – All rights reserved
are specified in 5.2. The semantic links among them are specified in 5.3. The relations of them are
illustrated in a concept diagram in Figure 1.
Figure 1 — Concept representation of single herbal medicament
A source or source material (3.1) is PartOfInterest (5.2.2) of Origin (5.2.1). The resultant material after
Processing (5.2.3) is a single herbal medicament, SHM.
Some medicines regulatory agencies (3.10) allow that the Origin (5.2.1) is not restricted to a single
species. SHM has its official names in a pharmacopeia or related documents according to the definition
therein.
EXAMPLE 1 The Chinese Pharmacopoeia defines that “Rhei Radix et Rhizoma” shall be made from one or some
[57]
of { Rheum palmatum L. or Rheum tanguticum Maxim. ex Balf or Rheum officinale Baill } .
EXAMPLE 2 The Chinese and European pharmacopoeias define the controlled term “Cimicifugae Rhizoma” to
[43] [57]
designate different species with different medicinal uses . See also the examples in 5.3.1.
[52]–[63]
NOTE There exist synonyms, homonyms and polysemes among the expressions in pharmacopoeias .
Kew’s “Medicinal Plant Name Services” is helpful for identifying these (www.kew.org/mpns; Royal Botanic
[28]–[30]
Gardens) .
5.2 Characterizing categories
5.2.1 Origin
Name of characterizing category: Origin
Description: Origin (5.2.1) is the characterizing category, which contains the designations of “medicinal plants”
as the characterizing concepts that are required in the SHM.
Appropriate value(s) (3.5) is/are bound to the semantic links in concerned contexts (3.6) by a domain constraint.
Values: The values shall have been previously defined in pharmacopoeias or related documents in each nation
and authorized respectively by each medicinal regulatory agency (3.10); some of the pharmacopoeias are listed
in References [52] to [63].
The values shall be the designations of { Origin } in the expression of scientific name.
Semantic Link from Semantic Link name Semantic Link to
Origin has PartOfInterest (3.3)
PartOfInterest isPartOf (5.3.2) Origin
[27]
NOTE 1 Scientific name is based on International Code of Nomenclature for algae, fungi, and plants (Melbourne Code) .
[28]–[30], [52]–[63]
NOTE 2 There exist many synonyms and homonyms among the expressions in pharmacopoeias . Different
scientific names that are potentially used by different pharmacopoeias for the same species. These are reported
[28]–[30]
WHO/WPRO-related work and Kew’s service is helpful for identifying canonical name of plant .
The version of the code system should also be noted, because taxonomic concepts in botany may change over time.
5.2.2 PartOfInterest
Name of characterizing category: PartOfInterest
Description: PartOfInterest (5.2.2) is the characterizing category, which contains the designations of “part(s) of
interest (3.3)” as the characterizing concepts that are required in the SHM.
Appropriate value(s) (3.5) is/are bound to the semantic links in concerned contexts (3.6) by a domain constraint.
Values: The values shall have been previously defined in pharmacopoeias or related documents in each nation
and authorized respectively by each medicine regulatory agency (3.10); some of the pharmacopoeias are listed
in References [52] to [63].
The values shall be the designations of { part(s) of interest }.
Semantic Link from Semantic Link name Semantic Link to
PartOfInterest isPartOf (5.3.2) Origin (5.2.1)
PartOfInterest isProcessedBy (5.3.3) Processing (5.2.3)
PartOfInterest is not always limited to one. It varies by nation and medical domain (3.9).
Because the ingredients of source (3.1) are determined by the PartOfInterest(s) of Origin(s), they shall always be identified
simultaneously.
EXAMPLE 1 “Ginseng” [as source] in < Kampo > [medical domain] is the < root > [PartOfInterest] which
[63]
isPartOf < Panax ginseng C.A.Mey > [Origin] .
EXAMPLE 2 “Ginseng” [as source] in < Chinese medicine > [medical domain] is
[57]
the < root > and < rhizome > [PartOfInterest] which isPartOf < Panax ginseng C.A.Mey > [Origin] .
EXAMPLE 3 “Sana” [as source] in < Unani > [medical domain] is the < leaf > [part of interest] isPartOf < Cassia
[55]
angustifolia Vahl > [Origin] .
EXAMPLE 4 “Sanna” (or má-kǎam kàek) [as source] in [medical domain] is the
[62]
and [PartOfInterest] which isPartOf [Origin] .
NOTE See also 5.3.1.
6 © ISO 2016 – All rights reserved
5.2.3 Processing
Name of characterizing category: Processing
Description: Processing (5.2.3) is the characterizing category which contains the designations of “processing
methods” as the characterizing concepts, that are required in the SHM.
Appropriate value(s) (3.5) is/are bound to the semantic links in concerned contexts (3.6) by a domain constraint.
Value: The values shall have been previously defined in pharmacopoeias or related documents in each nation
and authorized respectively by each Medicinal Regulatory Agency (3.10); some of the pharmacopoeias are listed
in References [52] to [63].
The values shall be the designations of { processing methods }.
Semantic Link from Semantic Link name Semantic Link to
PartOfInterest isProcessedBy (5.3.3) Processing
Processing isFollowedBy (5.3.4) Processing
PartOfInterest(s) shall be always identified simultaneously with Origin(s) (5.2.1) as source (3.1).
NOTE Processing is occasionally performed with assistant material (3.4), which is specified if necessary.
EXAMPLE 1 “Ginseng root and rhizome” [as source] isProcessedBy < removing fibrous root > [Processing]
[57]
isFollowedBy < sun-dry > [Processing] .
EXAMPLE 2 “Rhubarb root and rhizome” [as source] isProcessedBy < removing root hair > [Processing]
[57]
isFollowedBy < removing epidermis > [Processing] isFollowedBy < sun-dry > [Processing] .
5.3 Semantic links
5.3.1 isMadeOf
Name of semantic link: isMadeOf
Context: terminology - semantic content - herbal medicament (at high level of concept)
C
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