1、 ISO 2016 Health informatics Categorial structure for representation of herbal medicaments in terminological systems Informatique de sant Structure catgorielle pour la reprsentation de mdicaments base de plantes dans les systmes terminologiques TECHNICAL SPECIFICATION ISO/TS 18062 Reference number I
2、SO/TS 18062:2016(E) First edition 2016-12-15 ISO/TS 18062:2016(E)ii ISO 2016 All rights reserved COPYRIGHT PROTECTED DOCUMENT ISO 2016, Published in Switzerland All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized otherwise in any form or by any
3、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 ISOs member body in the country of the requester. ISO copyright office Ch. de Blandonnet 8 CP 401
4、CH-1214 Vernier, Geneva, Switzerland Tel. +41 22 749 01 11 Fax +41 22 749 09 47 copyrightiso.org www.iso.org ISO/TS 18062:2016(E)Foreword iv Introduction v 1 Scope . 1 2 Normative references 2 3 T erms and definitions . 2 4 Abbreviated terms 4 5 Single herbal medicament (SHM) . 4 5.1 Overview 4 5.2
5、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、6.2.1 Required SHM . 9 6.2.2 Amount 10 6.3 Semantic links .11 6.3.1 isComposedOf11 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 ISO 2016 All rig
7、hts reserved iii Contents Page ISO/TS 18062:2016(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. Ea
8、ch 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 Internatio
9、nal 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 differen
10、t 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 n
11、ot 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 i
12、nformation given for the convenience of users and does not constitute an endorsement. For an explanation on the meaning of ISO specific terms and expressions related to conformit y assessment, as well as information about ISOs adherence to the World Trade Organization (WTO) principles in the Technic
13、al Barriers to Trade (TBT) see the following URL: www.iso.org/iso/foreword.html The committee responsible for this document is ISO/TC 215, Health informatics.iv ISO 2016 All rights reserved ISO/TS 18062:2016(E) Introduction Medicinal or pharmaceutical products (3.11, 3.12) derived from plants have c
14、omplicated 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 other medicinal plant
15、s 3263 . 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 materi
16、al 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
17、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 pharmaceutic
18、al 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 “common name” often designates different compositions of formulas in dif
19、ferent pharmacopoeias 2830, 5263 . Disagreement on the definitions of “sets of concepts” and “common names” of herbal medicines in various terminological resources (3.7) 10have caused confusion in international trade which increases risk of harm to patients and negative impact to scientific research
20、 including clinical tests. This problem should be resolved by standardization, while according respect to each pharmacopoeia and avoiding market distortion. ISO 860 2has already proposed an approach to this issue in preparing the harmonization of necessary concepts before “term standardization.” Thi
21、s approach implicitly requires the prior building of a well-structured backbone, i.e. “a set of concepts” for terms. For this purpose, ISO 1087-1, EN 12264 and ISO 17115 4 7define the structures of concepts and provide the necessary terms that designate the elements of concept structures. This frame
22、work 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 p
23、harmacopoeias. 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 investiga
24、tion 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 th
25、ose 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 r
26、ecognized 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 ISO 2016 All rights reserved v ISO/
27、TS 18062:2016(E) 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 thi
28、s 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 T
29、he 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 interope
30、rability 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 c
31、ategories 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 med
32、icament. 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 system
33、s, 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, fa
34、cilitate 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
35、 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;
36、any individual pharmaceutical or medicinal products, and combinations use with modern medicines. ISO 2016 All rights reserved 1 ISO/TS 18062:2016(E) 2 Normative references There are no normative references in this document. 3 T erms a nd definiti ons For the purposes of this document, the terms and
37、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.o
38、rg/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 me
39、aning 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 Dire
40、ctives: Article 30, 31, 32) and E.2.2 (European Pharmacopoeia) in ISO/TS 19844:2015, Annex E 26are 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 jurisdictio
41、n, 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 individua
42、l 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,
43、 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 p a r t of i n t er e s t part of the plant that is intended for use as a herbal substance (3.1) EXAMPLE Seed, root, rhizo
44、me, 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 sci
45、entific 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 ISO/TS 18062:2016(E) EXAMPLE Rice wine, liquor, vinegar, honey. 3.5 valuedesignation of a characterizing
46、 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 ei
47、ther 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 conce
48、pt 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
49、-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, seman
