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)
2、PD CEN ISO/TS 20440:2016 BSI Standards Publication WB11885_BSI_StandardCovs_2013_AW.indd 1 15/05/2013 15:06National foreword This Published Document is the UK implementation of CEN ISO/TS 20440:2016. The UK participation in its preparation was entrusted to Technical Committee IST/35, Health informat
3、ics. 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 for its correct application. The British Standards Institution 2016. Published by BSI
4、 Standards Limited 2016 ISBN 978 0 580 91041 8 ICS 35.240.80 Compliance with a British Standard cannot confer immunity from legal obligations. This Published Document was published under the authority of the Standards Policy and Strategy Committee on 31 July 2016. Amendments/corrigenda issued since
5、publication Date Text affected PUBLISHED DOCUMENT PD CEN ISO/TS 20440:2016 TECHNICAL 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 d
6、ata 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) Informatique de sant - Identification des produits mdicaux - Guide de mise en oeuvre des lme
7、nts de donnes et structures 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 - I
8、mplementierungsleitfaden 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 Spe
9、cification (CEN/TS) was 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 convert
10、ed into a European Standard. 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
11、) until the final decision 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, Hunga
12、ry, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and United Kingdom. EUROPEAN COMMITTEE FOR STANDARDIZATION COMIT EUROPEN DE NORMALISATION EUROPISCHES KOMITEE FR NORMUNG CEN-CENEL
13、EC Management Centre: Avenue 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 E PD CEN ISO/TS 20440:2016CEN ISO/TS 20440:2016 (E) 2 Contents Page European foreword . 3 PD CEN ISO/TS
14、 20440:2016CEN ISO/TS 20440:2016 (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 draw
15、n to the possibility that 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 followin
16、g countries are bound to 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,
17、 Norway, Poland, Portugal, 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 20440:2016 ISO/TS 20440:2016(E)Foreword iv Int
18、roduction v 1 Scope . 1 2 Organisation of controlled terms 1 2.1 General . 1 2.2 Code-term pair and coded concept . 2 2.2.1 General 2 2.2.2 Code-term pair. 2 2.2.3 Coded concept 5 2.3 Versioning 6 2.3.1 Versioning of the term . 6 2.3.2 Versioning of the terminology 9 3 Terminologies 9 3.1 General .
19、9 3.2 Pharmaceutical dose form .10 3.2.1 Pharmaceutical dose form overview .10 3.2.2 Pharmaceutical dose form schema .10 3.2.3 Pharmaceutical dose form example: Prolonged-release tablet 16 3.3 Combined pharmaceutical form .21 3.3.1 Combined pharmaceutical dose form overview 21 3.3.2 Combined pharmac
20、eutical dose form schema 22 3.3.3 Combined pharmaceutical dose form example: Powder and solvent for solution for injection .23 3.3.4 Other authorised combinations of terms Combined terms and combination packs 25 3.4 Unit of presentation .26 3.4.1 Unit of presentation overview 26 3.4.2 Unit of presen
21、tation schema .27 3.4.3 Unit of presentation example: Tablet 27 3.5 Route of administration .28 3.5.1 Route of administration overview .28 3.5.2 Route of administration schema .29 3.5.3 Route of administration example: Intravenous use 29 3.6 Packaging 30 3.6.1 Packaging overview 30 3.6.2 Packaging s
22、chema 30 3.6.3 Packaging example: Ampoule (Packaging category: Container) .31 3.6.4 Packaging example: Screw cap (Packaging category: Closure) 33 3.6.5 Packaging example: Oral syringe (Packaging category: Administration device) 34 3.6.6 Packaging concept summaries 36 4 Mapping of regional terms 36 4
23、.1 Differences in granularity between regional terminologies .36 4.2 Organisation of regional terms in the database 38 4.2.1 General.38 4.2.2 Addition of regional terms to the database .38 4.2.3 Mapping regional terms to central coded concepts .41 4.2.4 Versioning of mapped regional terms 41 4.2.5 M
24、apped regional term example: Extended-release caplet .41 Bibliography .43 ISO 2016 All rights reserved iii Contents Page PD CEN ISO/TS 20440:2016 ISO/TS 20440:2016(E) Foreword ISO (the International Organization for Standardization) is a worldwide federation of national standards bodies (ISO member
25、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 committee. International organizations, governmental
26、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 and those intended for its further maintenance are
27、 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, Part 2 (see www.iso.org/directives). Attention is d
28、rawn 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 o
29、n 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 terms and expressions related to conformity asses
30、sment, 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 215, Health informatics.iv ISO 2016 All rights reserved PD CEN ISO/TS 20
31、440:2016 ISO/TS 20440:2016(E) Introduction The terminologies described in EN/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
32、describe the concepts covered in ISO 11239 within their regions; these terminologies 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
33、Technical Specification is to describe how these controlled vocabularies are constructed and illustrate their use for ISO 11239 implementation. ISO 2016 All rights reserved v PD CEN ISO/TS 20440:2016 Health informatics Identification of medicinal products Implementation guide for ISO 11239 data elem
34、ents and structures for the unique identification and exchange of regulated information on pharmaceutical dose forms, units of presentation, routes of administration and packaging 1 Scope This Technical Specification describes data elements and structures for the unique identification and exchange o
35、f regulated information on pharmaceutical dose forms, units of presentation, routes 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 c
36、onsult the terminologies and locate the appropriate terms for the concepts that they 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
37、 terms. The codes provided for the terms can then be used in the relevant fields in 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 vocabularie
38、s; any regional authorities or software vendors who wish to use the controlled vocabularies 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 hiera
39、rchy of the controlled vocabularies in order to help identify the most appropriate 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 t
40、his Technical Specification are provided for illustration purposes only, and are not intended to represent the final terminology. 2 Organisation of controlled terms 2.1 General This Clause describes how each controlled term is built, describing the data types used to convey the information and the v
41、ersioning requirements for tracking their creation and evolution. Clause 3 describes the 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 tit
42、le of the field and a table containing the following: “User Guidance”, a description of the field; “Data Type”, a description of the data type; TECHNICAL SPECIFICATION ISO/TS 20440:2016(E) ISO 2016 All rights reserved 1 PD CEN ISO/TS 20440:2016 ISO/TS 20440:2016(E) “Conformance”, a description of wh
43、ether the field is mandatory, optional, or conditional; “Value Allowed”, indicating the possible values for the field; “Business Rules”, providing technical guidance for the field. 2.2 Code-term pair and coded concept 2.2.1 General The code-term pair and the coded concept are the data types that are
44、 used to represent the information that is required to describe each term in each terminology or sub-vocabulary, in each language/region combination. 2.2.2 Code-term pair 2.2.2.1 Code-term pair overview This is the underlying class for each term, and is used to describe and define a term in a specif
45、ic language and for a specific region. It contains the core attributes for each concept, including 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 text
46、ual comment, and the language and region codes. Each controlled term or sub-term has a unique code-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
47、or definition differs between UK English and US English, it is possible to reflect this difference. 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 t
48、erms and definitions need to be provided for the second region, or whether the terms and definitions 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.
49、The language/region combination chosen to represent the “value” shall always be created first to represent 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: Code User 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:
