1、Health informatics Identification of medicinal products Implementation guide for ISO 11239 data elements and structures for the unique identification and exchange of regulated information on pharmaceutical dose forms, units of presentation, routes of administration and packaging (ISO/TS 20440:2016)P
2、D CEN ISO/TS 20440:2016BSI Standards PublicationWB11885_BSI_StandardCovs_2013_AW.indd 1 15/05/2013 15:06National forewordThis Published Document is the UK implementation of CEN ISO/TS20440:2016. The UK participation in its preparation was entrusted to TechnicalCommittee IST/35, Health informatics.A
3、list of organizations represented on this committee can be obtained onrequest to its secretary.This publication does not purport to include all the necessary provisions ofa contract. Users are responsible for its correct application. The British Standards Institution 2016.Published by BSI Standards
4、Limited 2016ISBN 978 0 580 91041 8ICS 35.240.80Compliance with a British Standard cannot confer immunity fromlegal obligations.This Published Document was published under the authority of theStandards Policy and Strategy Committee on 31 July 2016.Amendments/corrigenda issued since publicationDate Te
5、xt affectedPUBLISHED DOCUMENTPD CEN ISO/TS 20440:2016TECHNICAL SPECIFICATION SPCIFICATION TECHNIQUE TECHNISCHE SPEZIFIKATION CEN ISO/TS 20440 June 2016 ICS 35.240.80 English Version Health informatics - Identification of medicinal products - Implementation guide for ISO 11239 data elements and struc
6、tures for the unique identification and exchange of regulated information on pharmaceutical dose forms, units of presentation, routes of administration and packaging (ISO/TS 20440:2016) Informatique de sant - Identification des produits mdicaux - Guide de mise en oeuvre des lments de donnes et struc
7、tures pour lidentification unique et lchange dinformations rglementes sur les formes des doses pharmaceutiques, les units de prsentation, les voies dadministration et les emballages de lISO 11239 (ISO/TS 20440:2016) Medizinische Informatik - Identifikation von Arzneimitteln - Implementierungsleitfad
8、en fr ISO 11239 Datenelemente und Strukturen zur eindeutigen Identifikation und zum Austausch von vorgeschriebenen Informationen ber pharmazeutische Darreichungsformen, pharmazeutische Konventionseinheiten, Anwendungsarten und Verpackungen (ISO/TS 20440:2016) This Technical Specification (CEN/TS) wa
9、s approved by CEN on 29 May 2016 for provisional application. The period of validity of this CEN/TS is limited initially to three years. After two years the members of CEN will be requested to submit their comments, particularly on the question whether the CEN/TS can be converted into a European Sta
10、ndard. CEN members are required to announce the existence of this CEN/TS in the same way as for an EN and to make the CEN/TS available promptly at national level in an appropriate form. It is permissible to keep conflicting national standards in force (in parallel to the CEN/TS) until the final deci
11、sion about the possible conversion of the CEN/TS into an EN is reached. CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland,
12、Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey andUnited Kingdom. EUROPEAN COMMITTEE FOR STANDARDIZATION COMIT EUROPEN DE NORMALISATION EUROPISCHES KOMITEE FR NORMUNG CEN-CENELEC Management Centre: A
13、venue Marnix 17, B-1000 Brussels 2016 CEN All rights of exploitation in any form and by any means reserved worldwide for CEN national Members. Ref. No. CEN ISO/TS 20440:2016 EPD CEN ISO/TS 20440:2016CEN ISO/TS 20440:2016 (E) 2 Contents Page European foreword . 3 PD CEN ISO/TS 20440:2016CEN ISO/TS 20
14、440:2016 (E) 3 European foreword This document (CEN ISO/TS 20440:2016) has been prepared by Technical Committee ISO/TC 215 “Health informatics” in collaboration with Technical Committee CEN/TC 251 “Health informatics” the secretariat of which is held by NEN. Attention is drawn to the possibility tha
15、t some of the elements of this document may be the subject of patent rights. CEN and/or CENELEC shall not be held responsible for identifying any or all such patent rights. According to the CEN-CENELEC Internal Regulations, the national standards organizations of the following countries are bound to
16、 announce this Technical Specification: Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portuga
17、l, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the United Kingdom. Endorsement notice The text of ISO/TS 20440:2016 has been approved by CEN as CEN ISO/TS 20440:2016 without any modification. PD CEN ISO/TS 20440:2016ISO/TS 20440:2016(E)Foreword ivIntroduction v1 Scope . 12 Or
18、ganisation of controlled terms 12.1 General . 12.2 Code-term pair and coded concept . 22.2.1 General 22.2.2 Code-term pair. 22.2.3 Coded concept 52.3 Versioning 62.3.1 Versioning of the term . 62.3.2 Versioning of the terminology 93 Terminologies 93.1 General . 93.2 Pharmaceutical dose form . 103.2.
19、1 Pharmaceutical dose form overview .103.2.2 Pharmaceutical dose form schema .103.2.3 Pharmaceutical dose form example: Prolonged-release tablet 163.3 Combined pharmaceutical form . 213.3.1 Combined pharmaceutical dose form overview 213.3.2 Combined pharmaceutical dose form schema 223.3.3 Combined p
20、harmaceutical dose form example: Powder and solvent for solution for injection .233.3.4 Other authorised combinations of terms Combined terms and combination packs 253.4 Unit of presentation . 263.4.1 Unit of presentation overview 263.4.2 Unit of presentation schema . 273.4.3 Unit of presentation ex
21、ample: Tablet 273.5 Route of administration . 283.5.1 Route of administration overview . 283.5.2 Route of administration schema . 293.5.3 Route of administration example: Intravenous use 293.6 Packaging 303.6.1 Packaging overview 303.6.2 Packaging schema 303.6.3 Packaging example: Ampoule (Packaging
22、 category: Container) .313.6.4 Packaging example: Screw cap (Packaging category: Closure) 333.6.5 Packaging example: Oral syringe (Packaging category: Administration device) 343.6.6 Packaging concept summaries 364 Mapping of regional terms 364.1 Differences in granularity between regional terminolog
23、ies .364.2 Organisation of regional terms in the database 384.2.1 General. 384.2.2 Addition of regional terms to the database .384.2.3 Mapping regional terms to central coded concepts .414.2.4 Versioning of mapped regional terms 414.2.5 Mapped regional term example: Extended-release caplet .41Biblio
24、graphy .43 ISO 2016 All rights reserved iiiContents PagePD CEN ISO/TS 20440:2016ISO/TS 20440:2016(E)ForewordISO (the International Organization for Standardization) is a worldwide federation of national standards bodies (ISO member bodies). The work of preparing International Standards is normally c
25、arried 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-governmental, in liaison with ISO, also take part in the wor
26、k. 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 ISO/IEC Directives, Part 1. In particular the diffe
27、rent 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 possibility that some of the elements of this document may
28、 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 patent declarations received (see www.iso.org/patent
29、s).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 assessment, as well as information about ISOs adherence to the WTO principles
30、 in the Technical Barriers to Trade (TBT), see the following URL: Foreword Supplementary information .The committee responsible for this document is ISO/TC 215, Health informatics.iv ISO 2016 All rights reservedPD CEN ISO/TS 20440:2016ISO/TS 20440:2016(E)IntroductionThe terminologies described in EN
31、/ISO 11239:2012 (hereafter referred to as ISO 11239) and in this Technical Specification are essential for the implementation of the IDMP standards as a whole.Each region traditionally uses its own sets of terminologies to describe the concepts covered in ISO 11239 within their regions; these termin
32、ologies are not harmonised with those of the other regions. Therefore, harmonised controlled terminologies need to be provided to ensure that all regions can refer to a given concept in the same manner. The purpose of this Technical Specification is to describe how these controlled vocabularies are
33、constructed and illustrate their use for ISO 11239 implementation. ISO 2016 All rights reserved vPD CEN ISO/TS 20440:2016Health informatics Identification of medicinal products Implementation guide for ISO 11239 data elements and structures for the unique identification and exchange of regulated inf
34、ormation on pharmaceutical dose forms, units of presentation, routes of administration and packaging1 ScopeThis Technical Specification describes data elements and structures for the unique identification and exchange of regulated information on pharmaceutical dose forms, units of presentation, rout
35、es of administration and packaging.Based on the principles outlined in this Technical Specification, harmonised controlled terminologies will be developed according to an agreed maintenance process, allowing users to consult the terminologies and locate the appropriate terms for the concepts that th
36、ey wish to describe. Provisions to allow for the mapping of existing regional terminologies to the harmonised controlled terminologies will also be developed in order to facilitate the identification of the appropriate terms. The codes provided for the terms can then be used in the relevant fields i
37、n the PhPID, PCID and MPID in order to identify those concepts.This Technical Specification is intended for use by: any organisation that might be responsible for developing and maintaining such controlled vocabularies; any regional authorities or software vendors who wish to use the controlled voca
38、bularies in their own systems and need to understand how they are created; owners of databases who wish to map their own terms to a central list of controlled vocabularies; other users who wish to understand the hierarchy of the controlled vocabularies in order to help identify the most appropriate
39、term to describe a particular concept.The terminology to be applied in the context of this Technical Specification and set out in ISO 11239 is under development. All codes, terms and definitions used as examples in this Technical Specification are provided for illustration purposes only, and are not
40、 intended to represent the final terminology.2 Organisation of controlled terms2.1 GeneralThis Clause describes how each controlled term is built, describing the data types used to convey the information and the versioning requirements for tracking their creation and evolution. Clause 3 describes th
41、e different types of terminologies and sub-vocabularies that use these data types, and any relevant relationships between them.Each field in Clause 2 is described under a separate subclause, consisting of the title of the field and a table containing the following: “User Guidance”, a description of
42、the field; “Data Type”, a description of the data type;TECHNICAL SPECIFICATION ISO/TS 20440:2016(E) ISO 2016 All rights reserved 1PD CEN ISO/TS 20440:2016ISO/TS 20440:2016(E) “Conformance”, a description of whether the field is mandatory, optional, or conditional; “Value Allowed”, indicating the pos
43、sible values for the field; “Business Rules”, providing technical guidance for the field.2.2 Code-term pair and coded concept2.2.1 GeneralThe code-term pair and the coded concept are the data types that are used to represent the information that is required to describe each term in each terminology
44、or sub-vocabulary, in each language/region combination.2.2.2 Code-term pair2.2.2.1 Code-term pair overviewThis is the underlying class for each term, and is used to describe and define a term in a specific language and for a specific region. It contains the core attributes for each concept, includin
45、g the identifier, the textual representation of the term (i.e. the controlled term itself), the definition, an optional domain to indicate whether a term is restricted to veterinary use, an optional textual comment, and the language and region codes.Each controlled term or sub-term has a unique code
46、-term pair for each language/region combination. This combination of language and region allows for regional variants of a specific language to be catered for; for example, where the spelling of a term or definition differs between UK English and US English, it is possible to reflect this difference
47、. Where terms and definitions already exist for a particular language for a particular region, and the same language is used in a second region, it is a regional implementation issue to decide whether terms and definitions need to be provided for the second region, or whether the terms and definitio
48、ns of the first region shall be used.When a new concept is required, a new coded concept must be created, and at least one code-term pair is required in order to hold the data to describe the concept. The language/region combination chosen to represent the “value” shall always be created first to re
49、present the concept, even when the request originates from a different language/region combination. The maintenance organisation shall provide instructions on how to request a new term or a revision to an existing term.2.2.2.2 Code-term pair: CodeUser Guidance This field contains a unique, machine-readable identifier for the code-term pair. In this Technical Specification, the following format is used for the code: XXX-12345678-LL-RRwhere XXX represents the class of term (see Table 1); 12345678 represents a unique 8-di
