1、Traditional Chinese medicine - Coding rules for Chinese medicines in supply chain managementBS ISO 20333:2017BSI Standards PublicationWB11885_BSI_StandardCovs_2013_AW.indd 1 15/05/2013 15:06National forewordThis British Standard is the UK implementation of ISO 20333:2017. The UK participation in its
2、 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 provisions of a contract. Users are responsible fo
3、r its correct application. The British Standards Institution 2017 Published by BSI Standards Limited 2017ISBN 978 0 580 88404 7ICS 11.120.10Compliance with a British Standard cannot confer immunity from legal obligations. This British Standard was published under the authority of the Standards Polic
4、y and Strategy Committee on 30 September 2017.Amendments/corrigenda issued since publicationDate Text affected BRITISH STANDARDBS ISO 20333:2017 ISO 2017Traditional Chinese medicine Coding rules for Chinese medicines in supply chain managementMdecine traditionnelle chinoise Rgles de codage des mdeci
5、nes chinoises dans la gestion de la chane logistiqueINTERNATIONAL STANDARDISO20333First edition2017-08-10Reference numberISO 20333:2017(E)BS ISO 20333:2017ISO 20333:2017(E)ii ISO 2017 All rights reservedCOPYRIGHT PROTECTED DOCUMENT ISO 2017, Published in SwitzerlandAll rights reserved. Unless otherw
6、ise 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 permission. Permission can be requested from either ISO at the address be
7、low 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 20333:2017ISO 20333:2017(E)Foreword ivIntroduction v1 Scope . 12 Normative references 1
8、3 Terms and definitions . 14 Coding principles . 24.1 Uniqueness . 24.2 Compatibility 24.3 Stability 25 Information coding 35.1 Retail products of Chinese medicines code 35.2 Medicinal code. 35.3 Company internal information code 35.3.1 General principles . 35.3.2 Producing area code . 35.3.3 Measur
9、ement unit code . 45.3.4 Grade code . 45.4 Code of production date 45.5 Code of batch number . 55.6 Code of batch numbers in logistic unit . 55.7 Code of logistic unit. 56 Representation of information identification . 56.1 One-dimensional bar code representation . 66.1.1 One-dimensional bar code re
10、presentation of retail trade account 66.1.2 One-dimensional bar code representation of non-retail trade account 66.1.3 One-dimensional bar code representation of logistic unit 66.2 Two-dimensional bar code representation 66.3 Radio frequency identification (RFID) representation 76.3.1 Technical requ
11、irements . 76.3.2 Requirements of encapsulation material 7Bibliography 8 ISO 2017 All rights reserved iiiContents PageBS ISO 20333:2017ISO 20333:2017(E)ForewordISO (the International Organization for Standardization) is a worldwide federation of national standards bodies (ISO member bodies). The wor
12、k 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 non-governme
13、ntal, 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 described in the
14、 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 to the possib
15、ility 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 ISO list of
16、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 voluntary nature of standards, the meaning of ISO specific terms and expressions related to c
17、onformity assessment, 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.This document was prepared by Technical Committee ISO/TC 249, Traditional Chinese medicine.
18、iv ISO 2017 All rights reservedBS ISO 20333:2017ISO 20333:2017(E)IntroductionThe popularity of medicinal products derived from natural materials, particularly herbal materials, is increasing rapidly. For example, the international market for medicines used in traditional Chinese medicine (TCM) was v
19、alued at USD 16 billion and is increasing at a rate of 10 % to 20 % per year.Most goods traded internationally use bar coding to monitor the movement and use of the products. For example, even pencils and erasers have bar codes which permit their individual identification. However, this does not cur
20、rently apply to medicines used in TCM. While at least 70 countries now have administrative systems in place to regulate TCM, the lack of bar coding is a barrier to the increasing trade and to ensuring the identity and quality of ingredients and products for the well-being of communities.This documen
21、t introduces a bar coding for TCM which is consistent with existing standards. It also provides a basis for similar coding systems for the products of related traditional health systems. ISO 2017 All rights reserved vBS ISO 20333:2017This page deliberately left blankTraditional Chinese medicine - Co
22、ding rules for Chinese medicines in supply chain management1 ScopeThis document specifies coding rules for Chinese medicines to assist in supply chain management. The coding provides information such as the trade item, producing area, unit, grade, production date, batch number, quantity of medicines
23、, and logistic unit. This includes Chinese Materia Medica and decoction pieces, but excludes granule forms of individual medicinals for prescriptions (GFIMP) and Chinese patent medicines (CPM).2 Normative referencesThe following documents are referred to in the text in such a way that some or all of
24、 their content constitutes requirements of this document. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies.ISO/IEC 15416 , Information technology Automatic identification and data capture te
25、chniques Bar code print quality test specification Linear symbolsISO/IEC 15418 , Information technology Automatic identification and data capture techniques GS1 Application Identifiers and ASC MH10 Data Identifiers and maintenanceISO/IEC 15420 , Information technology Automatic identification and da
26、ta capture techniques EAN/UPC bar code symbology specificationISO/IEC 15438 , Information technology Automatic identification and data capture techniques PDF417 bar code symbology specificationISO/IEC 16022 , Information technology Automatic identification and data capture techniques Data Matrix bar
27、 code symbology specificationISO/IEC 18000-6 , Information technology Radio frequency identification for item management Part 6: Parameters for air interface communications at 860 MHz to 960 MHz GeneralISO/IEC 18004 , Information technology Automatic identification and data capture techniques QR Cod
28、e bar code symbology specification3 Terms and definitionsFor 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 http:/www.iso.org/obp
29、IEC Electropedia: available at http:/www.electropedia.org/ 3.1Chinese medicinesubstance or combination of substances used under the guidance of traditional Chinese medicine (TCM) theory for medical care and the prevention and treatment of diseaseNote 1 to entry: This includes Chinese Materia Medica,
30、 decoction pieces, granule forms of individual medicinals for prescriptions (GFIMP), and Chinese patent medicines (CPM).INTERNATIONAL STANDARD ISO 20333:2017(E) ISO 2017 All rights reserved 1BS ISO 20333:2017ISO 20333:2017(E)SOURCE: ISO 18668-1:2016, 3.13.2supply chainlinked set of resources and pro
31、cesses that begins with the sourcing of raw material and extends through the delivery of products or services to the end user across the modes of transportNote 1 to entry: The supply chain may include vendors, manufacturing facilities, logistics providers, internal distribution centres, distributors
32、, wholesalers and other entities that lead to the end user.SOURCE: ISO 28000:2007, 3.93.3supply chain managementmanagement primarily concerned with the efficient integration of suppliers, factories, warehouses and stores so that the merchandise is produced and distributed in the right quantities, to
33、 the right locations and at the right time, and so as to minimize total system cost subject to satisfying service level requirements3.4global location numberGLNGS1 identification key used to identify physical locations or partiesNote 1 to entry: The key comprises a GS1 Company Prefix, Location Refer
34、ence, and Check Digit.SOURCE: GS1 General Specifications, modified3.5application identifierAInumeric prefixes describing the meaning, structure, and function of the GS1 element strings so they can be correctly processed in users application programs.SOURCE: GS1 General Specifications, modified3.6ser
35、ial shipping container codeSSCCGS1 identification key used to identify logistics unitsNote 1 to entry: The key comprises an Extension Digit, the GS1 Company Prefix, Serial Reference, and Check Digit.SOURCE: GS1 General Specifications, modified4 Coding principles4.1 UniquenessEach kind of Chinese med
36、icines corresponds to a unique code.4.2 CompatibilityThe coding rules are consistent with relevant existing International Standards.4.3 StabilityThe code for each Chinese medicine remains unchanged once assigned, as long as the basic characteristic of the medicinal does not change. Even if some Chin
37、ese medicines are discontinued for production and use, their codes should still be kept.2 ISO 2017 All rights reservedBS ISO 20333:2017ISO 20333:2017(E)5 Information coding5.1 Retail products of Chinese medicines codeAs demonstrated in Figure 1, coding of Chinese medicines adopts the structure of 13
38、 digits of data. The structure given in ISO/IEC 15420 shall be applied.Figure 1 Code structureA GS1 company prefix is a unique string of 4 to 12 digits used to issue GS1 identification keys.The first two or more digits of GS1 company prefix refer to GS1 prefix.Item reference is usually formulated by
39、 manufacturers. When GS1 company prefix is composed of 8 digits of data, Item reference is composed of 4 digits of data. Otherwise, when GS1 company prefix is composed of 7 digits of data, item reference is composed of 5 digits of data.The method calculation for check digit given in ISO/IEC 15420 sh
40、all be applied.5.2 Medicinal codeA medicinal code is composed of 17 digits of data, which is closely related to the ISO 18668 series. The coding rules should be consistent with the requirements of ISO 18668-1 and the medicinal code should be consistent with ISO 18668-2, ISO 18668-3 and ISO 18668-4.C
41、oding data corresponding to application identifier (AI) “251” indicates reference to a source entity, here expressed by the date of the medicinal code.See medicinal code in the ISO 18668 series.5.3 Company internal information code5.3.1 General principlesCompany internal information, whose length is
42、 alterable, consists of alphanumeric characters, and refers to a permanent serial code distributed by the manufacturer to an entity.Coding data corresponding to application identifier (AI) 91 indicates company internal information.As demonstrated in Table 1, the company internal information of Chine
43、se medicines consists of 17 digits of data in 3 ranks, including producing area code, measurement unit code and grade code.Table 1 Code structure of company internal informationAI Company internal information91Producing area (GLN)Measurement unit codeGrade codeN1N2N3N4N5N6N7N8N9N10N11N12N13N14N15N16
44、N175.3.2 Producing area codeThe producing area code refers to the code of place where the crude material is produced. The producing area code adopts the rules of the global location number (GLN), it consists of 13 digits of data, and is ISO 2017 All rights reserved 3BS ISO 20333:2017ISO 20333:2017(E
45、)used to differentiate the same variety from different producing areas. As demonstrated in Table 2, the structure given in GS1 general specifications for GLN shall be applied.Table 2 Code structure of GLN 5.3.3 Measurement unit codeInformation of the measurement unit of Chinese medicines is used to
46、distinguish different measurement units of the same variety. For example, cordyceps could be measured separately with measurement units such as kg, bag, and box. See Table 3 for details.Table 3 Measurement units codeCode Measurement units01 Gram02 Kilogram03 Millilitre04 Bar05 Piece06 Bottle07 Bag08
47、 Branch09 Grain10 Block11 Pair12 Box13 Pound5.3.4 Grade codeThe grade code is used to identify different grades of Chinese medicines.NOTE “00” indicates that this reserved coding is for future use on grading.5.4 Code of production dateThe production date is the production or assembly date determined
48、 by the manufacturer. The date may refer to the trade item itself or to items contained.Coding data corresponding to application identifier (AI) “11” indicates the production date. See the code format in Table 4.Table 4 Code of production dateAI Production Date11Year Month DayN1N2N3N4N5N6NOTE 1 Year
49、: it is denoted by two digits and cannot be omitted. For example, 2011 is denoted by “11”.4 ISO 2017 All rights reservedBS ISO 20333:2017ISO 20333:2017(E)NOTE 2 Month: it is denoted by two digits and cannot be omitted. For example, January is denoted by “01”.NOTE 3 Day: it is denoted by two digits. For example, the second day of a month is denoted by “02”. If a specific day is not necessary, it is replaced by “00”.5.5 Code of batch numberBatch number indicates data information related to a tr
