1、 ISO 2016 Traditional Chinese medicine Coding system for Chinese medicines Part 1: Coding rules for Chinese medicines Mdecine traditionnelle chinoise Systme de codage des mdecines chinoises Partie 1: Rgles de codage des mdecines chinoises INTERNATIONAL STANDARD ISO 18668-1 First edition 2016-04-01 R
2、eference number ISO 18668-1:2016(E) ISO 18668-1:2016(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 means, ele
3、ctronic 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 CH-1214 Ve
4、rnier, Geneva, Switzerland Tel. +41 22 749 01 11 Fax +41 22 749 09 47 copyrightiso.org www.iso.org ISO 18668-1:2016(E)Foreword iv Introduction v 1 Scope . 1 2 Normative references 1 3 T erms and definitions . 1 4 Coding principles . 2 4.1 Uniqueness . 2 4.2 Scientific integrity 2 4.3 Scalability 2 4
5、.4 Compatibility 2 4.5 Stability 2 5 Coding technology . 2 5.1 Technical basis 2 5.1.1 Layer 1 2 5.1.2 Layer 2 3 5.1.3 Layer 3 3 5.1.4 Layer 4 3 5.1.5 Layer 5 3 5.1.6 Layer 6 3 5.1.7 Layer 7 4 5.1.8 Layer 8 4 5.1.9 Layer 9 4 5.1.10 Layer 10 . 4 5.2 Structure . 4 5.3 Detailed description . 5 Annex A
6、(normative) Code table of layer 4 to layer 9 7 Annex B (normative) Calculation of check digit 17 Annex C (informative) Examples 18 Bibliography .22 ISO 2016 All rights reserved iii Contents Page ISO 18668-1:2016(E) Foreword ISO (the International Organization for Standardization) is a worldwide fede
7、ration 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 commi
8、ttee. 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 an
9、d 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, Par
10、t 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 t
11、he 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 on the meaning of ISO specific t
12、erms and expressions related to conformity assessment, as well as information about ISOs adherence to the WTO principles in the Technical Barriers to Trade (TBT) see the following URL: Foreword - Supplementary information The committee responsible for this document is ISO/TC 249, Traditional Chinese
13、 medicine. ISO 18668 consists of the following parts, under the general title Traditional Chinese medicine Coding system for Chinese medicines: Part 1: Coding rules for Chinese medicines Part 2: Codes for decoction pieces Part 3: Codes for Chinese materia medica Part 4: Codes for granule forms of in
14、dividual medicinals for prescriptionsiv ISO 2016 All rights reserved ISO 18668-1:2016(E) Introduction As the pharmaceutical materials extracted from natural and botanical products have become increasingly attractive, significant progress has been achieved in identifying new sources of natural produc
15、ts for traditional and alternative medicine. In particular, Chinese traditional medicine has been the focus of tremendous research, development and applications worldwide. Accordingly, Chinese medicinal materials are increasingly being used in countries around the world. Currently, there are more th
16、an 70 countries that have established administrative systems to regulate Chinese Medicine. At present, the annual sale of Chinese medicines has reached more than USD 16 billion and is increasing at a rate of 10 % to 20 % per year with great future potential. At the same time, concerns of harm to the
17、 body associated with the long-term use of synthetic drugs have been recognized. Therefore, many countries are developing vigorous controls and regulations on using antibiotics and other synthetic drugs, while recognizing the importance of traditional and alternative medicines. Thus, this brings mor
18、e opportunities for the development of the market of Chinese medicines. Today, bar codes are widely used for managing almost all ordinary products that are put up for sale, for example, an eraser or a pencil has its individually identifiable bar code. Yet so far, a bar coding system for products use
19、d in Chinese medicine has not been given sufficient attention, making it difficult to categorize the individual items for international trade and research development. This brings challenges and concerns in government supervision and proper use by patients. As products for medicinal use, Chinese med
20、icines could have bar codes that can be integrated into the current bar code system that is used for other commercial products. In this way, bar codes can be used to track sources and monitor the quality of the products. Therefore, there is an urgent need to develop a bar code system for Chinese med
21、icine products that will enable to identify each specific Chinese medicine product. The Coding System of Chinese Medicines is developed based on science and research rooted in plant taxonomy, Chinese medicine, Chinese medicinal processing, and other established regulatory handbooks and guidelines of
22、 GS1 General standard, central product classification (CPC) and ISO/IEC 15420, etc. The codes help to translate complicated names of a wide variety of decoction pieces, Chinese Materia Medica (raw materials), and granule forms of individual medicinals for prescriptions into transparent digits. In th
23、is way, each Chinese medicine corresponds to a unique code as its identification. The Coding System of Chinese Medicines aims to promote standardization and digitalization for Chinese medicine, to ensure authenticity, equality, fairness and transparency in international markets and trade and to faci
24、litate government supervision and regulation of Chinese medicine. It is hoped that it will help pharmaceutical enterprises to manage workflow and increase economic returns. It will help healthcare delivery organizations, such as hospitals and dispensaries, to improve information management systems t
25、hat can ensure the accuracy of dispensing, ensuring the safe and effective use of prescribed medicine. As it has been previously acknowledged, Chinese decoction pieces are processed products of Chinese Materia Medica, which are also known as raw materials. Thus when designing the coding system for C
26、hinese medicines, it is feasible that one set of rules could incorporate all the features of each category of Chinese medicines, as they share the same medicinal source and medical part. To be specific, their divergence and commodity attributes can be clearly described in one of the layers (layer 8)
27、 in this set of coding rules. Granule forms of individual medicinals for prescriptions are innovative products made from decoction pieces. Based on the same considerations of feasibility and cost-control, the granular forms can be included within the same set of rules for decoction pieces. However,
28、although Chinese patent medicines (CPM) are made from decoction pieces, their coding rules are more complicated and differ from decoction pieces. Therefore, this coding system is not fit for CPM, and coding rules for CPM need to be formulated separately. ISO 2016 All rights reserved v Traditional Ch
29、inese medicine Coding system for Chinese medicines Part 1: Coding rules for Chinese medicines 1 Scope This part of ISO 18668-1 specifies rules to encode Chinese medicines, including decoction pieces, Chinese Materia Medica (raw materials) and granule forms of individual medicinals for prescriptions
30、(GFIMP), but not Chinese patent medicines (CPM). Relevant coding standards for Kampo medicine, Korean medicine and other traditional medicines will be separately formulated as needed by experts in these areas. This part of ISO 18668-1 is suitable for decoction pieces, Chinese Materia Medica (raw mat
31、erials), and granule forms of individual medicinals for prescriptions (GFIMP) in the fields of clinical medication, scientific research and teaching, and statistics and management. 2 Normative references The following documents, in whole or in part, are normatively referenced in this document and ar
32、e indispensable for its application. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies. ISO/IEC 15420, Information technology Automatic identification and data capture techniques EAN/UPC bar
33、code symbology specification 3 T erms a nd definiti ons For the purposes of this document, the following terms and definitions apply. 3.1 Chinese medicine substance or combination of substances used under the guidance of traditional Chinese medicine (TCM) theory for medical care and the prevention a
34、nd 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). 3.2 Chinese Materia Medica CMM medicinal parts of medicinal plants, animals, and minerals after preli
35、minary processing, which are used as raw materials in Chinese medicines Note 1 to entry: This refers to the raw materials used to make decoction pieces. INTERNATIONAL ST ANDARD ISO 18668-1:2016(E) ISO 2016 All rights reserved 1 ISO 18668-1:2016(E) 3.3 decoction piece prescription medicinal processed
36、 from Chinese Materia Medica under the guidance of TCM and processing methods for Chinese medicines Note 1 to entry: Decoction pieces are directly used in clinical practice or the production of prepared medicines. 3.4 granule form of individual medicinal for prescriptions GFIMP granular preparation
37、processed from single decoction piece after extraction, concentration, and drying Note 1 to entry: This refers to a preparation of decoction pieces that can be directly dispensed without decocting. 3.5 layer set of the characters within the code EXAMPLE A sub-field within the code. 4 Coding principl
38、es 4.1 Uniqueness Each variety and processed form corresponds to a unique code. 4.2 S cientific int egrity The most stable properties, attributes, or characteristics of each Chinese medicine are selected as basis for classification and coding. The basic attributes, the main applications, as well as
39、its quality, of each Chinese medicine are reflected in the codes. 4.3 Scalability The coding rules allow sufficient space for expansion. 4.4 Compatibility The coding rules are consistent with relevant existing International Standards. 4.5 Stability The code for each Chinese medicine remains unchange
40、d once assigned, as long as the basic characteristic of the medicinal does not change. Even if some Chinese medicines are discontinued for production and use, their codes should still be kept. 5 Coding technology 5.1 Technical basis 5.1.1 Layer 1 Layer 1 with 1 digit, Chinese medicines, with the cat
41、egories of agriculture, forestry, animal husbandry, and fishery are symbolized by 0, which is developed according to central product classification (CPC) developed by United Nations Statistical Commission.2 ISO 2016 All rights reserved ISO 18668-1:2016(E) 5.1.2 Layer 2 Layer 2 with 1 digit, the prod
42、uct code of Chinese medicines, symbolized by 6, is developed according to the request of CPC and GB/T 7635.1-2002. It is used to express the natural and commodity properties of Chinese medicines, which is important for identification and trade. 5.1.3 Layer 3 Layer 3 with 1 digit, the main code of me
43、dicinal source, is encoded according to classification and codes of plants, which is based on Linnaean taxonomy categories with the modern Five Kingdoms classification. In layer 3, 1 refers to plant, 2 refers to animal, 3 refers to mineral, 4 refers to fungus, 5 refers to lichen, 6 refers to algae,
44、and 7 refers to mixed kingdom. 5.1.4 Layer 4 Layer 4 with 3 digits (001 to 999), the subdivided code of medicinal source, indicates sources (family or group) and serial numbers of Chinese medicines. 5.1.4.1 In the plant category, different families of plants are encoded according to a certain classi
45、fication rule from lower plants to higher plants. In layer 4, for the first digit, 1 refers to liverwort, 2 refers to moss, 3 refers to pteridophytes, 4 refers to gymnosperm, 5 and 6 refers to Archichlamydeae of dicotyledoneae, 7 refers to Sympetalae of dicotyledoneae, and 9 refers to monocotyledon.
46、 0 and 8 are designed for future extension as needed. 5.1.4.2 In the animal category, different families of animals are encoded according to a certain classification rule from lower animals to higher animals, followed by Porifera, Coelenterata, Annulata, Mollusca, Arthropoda, Ectoprocta and Phylum C
47、hordata. 5.1.4.3 In the mineral category, groups of minerals are encoded according to a certain classification rule from simple minerals to complex minerals, followed by Elemental mineral, Sulfides and Related Analogues, Oxides and hydroxides, Oxysalt, Halide,Magmatic rocks, Metamorphic rocks, and F
48、ossils. 5.1.5 Layer 5 Layer 5 with 1 digit, the main code of medicinal part, ranged from 1 to 9, in which different numbers stand for different kinds of medicinal parts. 5.1.5.1 In the plant category, medicinal parts are divided into roots and bulbs, stems, woods, cortex and leaves, flowers, fruits
49、and seeds, whole plants, and other products, symbolized by 1, 2, 3, 4, 5, and 9 respectively. 5.1.5.2 In the animal category, medicinal parts are divided into 4 subdivisions. One indicates the whole animal and eviscerated animal, 2 indicates animal skin, horn, scale, conch, 3 indicates animal skeleton and visceral organ, 4 indicates animal product and processed goods. 5.1.5.3 In the fungus category, medicinal parts are divided into mycelium, sporocarp, and other products, which are symbolized by 1, 2, and 9 respectively. 5.1.6 L
