1、BS ISO 19465:2017Traditional Chinese medicine Categories of traditionalChinese medicine (TCM) clinicalterminological systemsBSI Standards PublicationWB11885_BSI_StandardCovs_2013_AW.indd 1 15/05/2013 15:06BS ISO 19465:2017 BRITISH STANDARDNational forewordThis British Standard is the UK implementati
2、on of ISO 19465:2017.The UK participation in its preparation was entrusted to Technical Committee CH/100/1, Traditional Chinese Medicine.A list of organizations represented on this committee can be obtained on request to its secretary.This publication does not purport to include all the necessary pr
3、ovisions of a contract. Users are responsible for its correct application. The British Standards Institution 2017.Published by BSI Standards Limited 2017ISBN 978 0 580 86655 5 ICS 01.040.11; 11.020.99 Compliance with a British Standard cannot confer immunity from legal obligations.This British Stand
4、ard was published under the authority of the Standards Policy and Strategy Committee on 31 March 2017.Amendments/corrigenda issued since publicationDate T e x t a f f e c t e dBS ISO 19465:2017 ISO 2017Traditional Chinese medicine Categories of traditional Chinese medicine (TCM) clinical terminologi
5、cal systemsMdecine traditionnelle chinoise Catgories de systmes terminologiques de mdecine traditionnelle chinoise (MTC) cliniqueINTERNATIONAL STANDARDISO19465First edition2017-02Reference numberISO 19465:2017(E)BS ISO 19465:2017ISO 19465:2017(E)ii ISO 2017 All rights reservedCOPYRIGHT PROTECTED DOC
6、UMENT ISO 2017, Published in SwitzerlandAll rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized otherwise in any form or by any means, electronic or mechanical, including photocopying, or posting on the internet or an intranet, without prior written
7、 permission. Permission can be requested from either ISO at the address below or ISOs member body in the country of the requester.ISO copyright officeCh. de Blandonnet 8 CP 401CH-1214 Vernier, Geneva, SwitzerlandTel. +41 22 749 01 11Fax +41 22 749 09 47copyrightiso.orgwww.iso.orgBS ISO 19465:2017ISO
8、 19465:2017(E)Foreword ivIntroduction v1 Scope . 12 Normative references 13 Terms and definitions . 14 Classification principles of TCMCTS . 24.1 Practicability 24.2 Internality and systematic feature . 24.3 Extendibility 25 Categorial structure of a TCM clinical terminological system (TCMCTS) 35.1
9、Overview 35.2 Symptom and sign 35.3 Examination objects . 45.4 Disease and pattern 45.4.1 Overview . 45.4.2 Disease 45.4.3 Pattern 45.5 TCM operational approach . 45.6 Cause and mechanism of disease 45.7 Theory and experience 55.8 Therapeutic principle and method of treatment . 55.9 Chinese medicina
10、ls 55.10 Body system. 55.11 Staging and transmission/transmutation . 55.12 TCM internal substance . 55.13 Environment or geographic location in TCM 55.14 TCM equipment and device 55.15 Unit of measurement and qualifier value in TCM . 65.16 Linkage . 65.17 Medical case record structure 65.18 Phrase .
11、 6Annex A (informative) Diagram of TCMCTS hierarchical structure . 7Bibliography 8 ISO 2017 All rights reserved iiiContents PageBS ISO 19465:2017ISO 19465:2017(E)ForewordISO (the International Organization for Standardization) is a worldwide federation of national standards bodies (ISO member bodies
12、). 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 no
13、n-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 descri
14、bed 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
15、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
16、 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 on the meaning of ISO specific terms and expressions related to conformity assessmen
17、t, as well as information about ISOs adherence to the World Trade Organization (WTO) principles in the Technical Barriers to Trade (TBT) see the following URL: www .iso .org/ iso/ foreword .html.The committee responsible for this document is ISO/TC 249, Traditional Chinese medicine.iv ISO 2017 All r
18、ights reservedBS ISO 19465:2017ISO 19465:2017(E)IntroductionClinical terms used in traditional Chinese medicine (TCM) healthcare are distinct from those used in health care systems based on biomedicine. The proliferation of computer applications and increase of electronic communication in TCM health
19、care call urgently for specific standards. A terminological system is required to support a consistent way of indexing, storing, retrieving and aggregating clinical data of TCM. However, the process of standardization of clinical terminology of TCM is not compatible with the needs. The large number
20、of clinical terms in the TCM system cannot be effectively managed without classification. The development of the category framework is a fundamental part of the terminological system.The objective of this document is to express a core categorial structure of TCM clinical terms. The development of an
21、 International Standard will help existing users to develop a robust logical TCM clinical terminology system.The potential uses for this categorial structure are as follows: support developers of TCM clinical terminology systems (TCMCTS); support developers of new terminology systems concerning TCM;
22、 facilitate the representation of TCM clinical information using a standardized core model in a manner suitable for computer processing; facilitate the mapping between TCM terminologies and biomedicine terminological systems.The target groups for this document are the following: developers of TCM cl
23、inical terminology systems; developers of information systems that require a structured framework of concepts to facilitate implementation; specialists who require common models of knowledge to facilitate the analysis of current and legacy data from one or more information systems; clinicians and co
24、ders, to provide greater consistency in structure and organization when entering and retrieving data using one or more terminology systems. ISO 2017 All rights reserved vBS ISO 19465:2017BS ISO 19465:2017Traditional Chinese medicine Categories of traditional Chinese medicine (TCM) clinical terminolo
25、gical systems1 ScopeThis document specifies a categorial structure within the subject field of traditional Chinese medicine (TCM) clinical practice. It describes the upper-level categories of TCM clinical terms and the nomenclature of the hierarchical categories. It is applicable only to clinical te
26、rminological systems in TCM disciplines, not to a comprehensive categorial structure of TCM, the conceptual definition of the hierarchy categories, and terms for individual TCM concepts.The following are considered outside the scope of this document: comprehensive categories of TCM; the conceptual d
27、efinition of the hierarchy categories. terms for individual TCM concepts; the terms or categories of Kampo, Korean medicine and other traditional medicines.2 Normative referencesThere are no normative references in this document.3 Terms and definitionsFor the purposes of this document, the following
28、 terms and definitions apply.ISO and IEC maintain terminological databases for use in standardization at the following addresses: IEC Electropedia: available at h t t p :/ www .electropedia .org/ ISO Online browsing platform: available at h t t p :/ www .iso .org/ obp3.1conceptunit of knowledge crea
29、ted by a unique combination of characteristicsNote 1 to entry: Concepts are not necessarily bound to particular languages. They are, however, influenced by the social or cultural background often leading to different categorizations.SOURCE: ISO 10871:2000, 3.2.1, modified3.2concept systemset of conc
30、epts (3.1) structured according to the relations among themSOURCE: ISO 10871:2000, 3.2.11INTERNATIONAL STANDARD ISO 19465:2017(E) ISO 2017 All rights reserved 1BS ISO 19465:2017ISO 19465:2017(E)3.3terminologystructured human and machine-readable representation of clinical concepts (3.1) required dir
31、ectly or indirectly to describe health conditions and healthcare activities, and allow their subsequent retrieval or analysisSOURCE: ISO 18104:2014, 3.1.9, modified3.4terminological systemset of concepts (3.1) structured according to the relations among them, each concept being represented by a sign
32、 which denotes itSOURCE: ISO 18308:2011, 3.50, modified3.5class hierarchyordering of classes, in which a subclass is a specialization of its superclassSOURCE: ISO/IEC/IEEE 24765:2010, 3.4123.6superclassclass that is one step above another class in a class inclusion hierarchySOURCE: ISO/IEC Guide 772
33、:2008, 2.22, modified3.7subclassclass that is one step below another class in a class inclusion hierarchySOURCE: ISO/IEC Guide 772:2008, 2.21, modified4 Classification principles of TCMCTSThe following principles should be considered:4.1 PracticabilityThe concept and classification of the terms shal
34、l be based on the aim of serving the clinical application of TCM. The practicability and convenience during practice shall be taken into consideration. The hierarchical framework of concepts of TCM will be developed. The structure shall be established for the purpose of supporting electric medical r
35、ecords and medical insurance.4.2 Internality and systematic featureOriginating from the need of the clinical practice of Chinese medicine, all the commonly encountered clinical terms of Chinese medicine shall be covered in the system. Clinical terms shall be sequenced systematically, scientifically
36、and appropriately according to the property and characteristics in clinical practice. One concept shall only exist in one specific hierarchical structure.4.3 ExtendibilityIn order to provide conditions for the further expansion of the system, the extendibility shall be considered in advance in the p
37、lanning stage of the classification system to guarantee the integrality of the existing system when new items are added.2 ISO 2017 All rights reservedBS ISO 19465:2017ISO 19465:2017(E)5 Categorial structure of a TCM clinical terminological system (TCMCTS)5.1 OverviewTCM clinical terminological syste
38、m (TCMCTS) is a clinical terminology of TCM that provides clinical content and expressivity for clinical documentation and reporting. It can be used to code, retrieve, and analyse clinical data. The terminology is composed of 17 class hierarchies with the objective of representing clinical informati
39、on across the scope of TCM. Hierarchy content classifies highlevel concepts (superclasses) which include symptom and sign, four examination objects, disease and pattern, TCM operational approach, cause and mechanism of disease, theory and experience, therapeutic principle and method of treatment, Ch
40、inese medicinals, body system, staging and transmission/transmutation, TCM internal substance, environment or geographical location in TCM, TCM equipment and device, unit of measurement and qualifier value in TCM, linkage, medical case record structure, phrase.NOTE See Annex A for a diagram of the T
41、CMCTS hierarchical structure.5.2 Symptom and sign5.2.1 Concepts in this hierarchy represent a (bodily or mental) phenomenon, circumstance or change of condition arising from and accompanying a disease or other pathological condition. Subjective indications or behaviour disorder perceptible to the pa
42、tient, and the abnormal signs discovered by a doctor, are included.5.2.2 This hierarchy contains three subhierarchies: symptom and sign through four diagnostic methods, symptom and sign through analysing of the physical constitutions of the patients, and symptom and sign through diagnosis with instr
43、uments of TCM.5.2.3 Symptom and sign through the four diagnostic methods includes various clinical manifestations and signs collected by inspection, auscultation and olfaction, inquiring and palpation. ISO 2017 All rights reserved 3BS ISO 19465:2017ISO 19465:2017(E)5.2.4 Symptom and sign through ana
44、lysing the physical constitutions of the patients includes symptoms that reflect the features of the body constitution of the patient.5.2.5 Symptom and sign through diagnosis with instruments of TCM includes information collected by diagnostic and treatment instruments.5.3 Examination objectsExamina
45、tion object concepts represent objects according to four examinations and could be classified as inspection object, auscultation (listening) and olfaction(smelling) object, inquiring (inquiry) object, and palpation object.5.4 Disease and pattern5.4.1 OverviewThe disease and pattern class hierarchy c
46、ontains two subclasses: a) disease and b) pattern. The concepts in disease represent a condition of being (more or less seriously) out of health, and the symptoms, signs, behaviour and pathological changes are always abnormal. The concepts in pattern describe diagnostic conclusions or conditions of
47、the pathological changes at a certain stage of a disease, including the location, cause, and nature of the diseases as well as the trend of development.5.4.2 DiseaseThe concepts under disease can be divided into 13 subclasses in accordance with traditional classification methods: disease of internal
48、 medicine, surgical disease, gynaecological disease, paediatric disease, diseases in ophthalmology and earnosethroat department, diseases in orthopaedics and traumatology, disease of impediment, flaccidity and tumour, epidemic disease, intoxication, symptomatic disease, infectious disease, parasitic
49、 disease and other diseases.6 75.4.3 PatternThe concepts under the pattern subclass are based on the system of differentiation on patterns, which are divided into patterns of cause of disease; patterns of YinYangQiBloodFluidHumour and Phlegm, pattern of VisceraBowels and meridians; patterns of six meridians, patterns of DefenceQiNutrientBlood, patterns of Classical Formula, and other patterns, and then further divide into sub-branches.5.5 TCM operational approachTCM operational
