EN ISO 11240-2012 en Health informatics - Identification of medicinal products - Data elements and structures for the unique identification and exchange of units of measurement《健康信.pdf

1、raising standards worldwideNO COPYING WITHOUT BSI PERMISSION EXCEPT AS PERMITTED BY COPYRIGHT LAWBSI Standards PublicationBS EN ISO 11240:2012Health informatics Identification of medicinal products Data elements and structures for the unique identification and exchange of units of measurementBS EN I

2、SO 11240:2012 BRITISH STANDARDNational forewordThis British Standard is the UK implementation of EN ISO 11240:2012.The UK participation in its preparation was entrusted to Technical Committee IST/35, Health informatics.A list of organizations represented on this committee can be obtained on request

3、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 2012. Published by BSI Standards Limited 2012ISBN 978 0 580 71937 0 ICS 35.240.80 Compliance with a British S

4、tandard cannot confer immunity from legal obligations.This British Standard was published under the authority of the Standards Policy and Strategy Committee on 30 November 2012.Amendments issued since publicationDate T e x t a f f e c t e dEUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN ISO 112

5、40 November 2012 ICS 35.240.80 English Version Health informatics - Identification of medicinal products - Data elements and structures for the unique identification and exchange of units of measurement (ISO 11240:2012) Informatique de sant - Identification des mdicaments - lments de donnes et struc

6、tures pour lidentification unique et lchange dinformations sur les units de mesure (ISO 11240:2012) Medizinische Informatik - Identifikation von Arzneimitteln - Datenelemente, Struktur und kontrolliertes Vokabular fr Maeinheiten (ISO 11240:2012) This European Standard was approved by CEN on 24 May 2

7、012. CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this European Standard the status of a national standard without any alteration. Up-to-date lists and bibliographical references concerning such national standards may be obtained

8、 on application to the CEN-CENELEC Management Centre or to any CEN member. This European Standard exists in three official versions (English, French, German). A version in any other language made by translation under the responsibility of a CEN member into its own language and notified to the CEN-CE

9、NELEC Management Centre has the same status as the official versions. 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, It

10、aly, 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 Management Centre: Avenue Marnix

11、17, B-1000 Brussels 2012 CEN All rights of exploitation in any form and by any means reserved worldwide for CEN national Members. Ref. No. EN ISO 11240:2012: EBS EN ISO 11240:2012EN ISO 11240:2012 (E) 3 Foreword This document (EN ISO 11240:2012) has been prepared by Technical Committee ISO/TC 215 “H

12、ealth informatics“ in collaboration with Technical Committee CEN/TC 251 “Health informatics” the secretariat of which is held by NEN. This European Standard shall be given the status of a national standard, either by publication of an identical text or by endorsement, at the latest by May 2013, and

13、conflicting national standards shall be withdrawn at the latest by May 2013. Attention is drawn 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

14、 to the CEN/CENELEC Internal Regulations, the national standards organisations of the following countries are bound to implement this European Standard: Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, Former Yugoslav Republic of Macedonia, France, Germany, Gre

15、ece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the United Kingdom. Endorsement notice The text of ISO 11240:2012 has been approved by CEN as a EN ISO 11240:2012 wi

16、thout any modification. BS EN ISO 11240:2012ISO 11240:2012(E) ISO 2012 All rights reserved iiiContents PageForeword ivIntroduction v1 Scope 12 Normative references . 13 Terms, definitions and abbreviated terms 13.1 Terms and definitions . 13.2 Abbreviations . 74 Structures and vocabularies 84.1 Over

17、view . 84.2 Metrological concepts 84.3 Semantics of units of measurement 114.4 Vocabulary for units of measurement 124.5 Domain model 144.6 Data elements and technical data model 164.7 Operational attributes 25Annex A (informative) Using units of measurement for expression of medicinal product stren

18、gth . 27Annex B (informative) Examples to describe data elements 28Annex C (informative) Example Controlled terminology mapping 32Annex D (informative) Domain analysis model 37Bibliography .45BS EN ISO 11240:2012ISO 11240:2012(E)ForewordISO (the International Organization for Standardization) is a w

19、orldwide federation 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

20、on that committee. 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.International Standards are drafted

21、 in accordance with the rules given in the ISO/IEC Directives, Part 2.The main task of technical committees is to prepare International Standards. Draft International Standards adopted by the technical committees are circulated to the member bodies for voting. Publication as an International Standar

22、d requires approval by at least 75 % of the member bodies casting a vote.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.ISO 11240 was prepared by Tec

23、hnical Committee ISO/TC 215, Health informatics.iv ISO 2012 All rights reservedBS EN ISO 11240:2012ISO 11240:2012(E)IntroductionThis International Standard was developed in response to a worldwide demand for internationally harmonized specifications for medicinal products. It is one of five standard

24、s which together provide the basis for the unique identification of medicinal products. The group of standards comprises:ISO 11615, Health informatics Identification of medicinal products Data elements and structures for the unique identification and exchange of regulated medicinal product informati

25、on;ISO 11616, Health informatics Identification of medicinal products Data elements and structures for the unique identification and exchange of regulated pharmaceutical product information;ISO 11238, Health informatics Identification of medicinal products Data elements and structures for the unique

26、 identification and exchange of regulated information on substances;ISO 11239, Health informatics Identification of medicinal products Data elements and structures for the unique identification and exchange of regulated information on pharmaceutical dose forms, units of presentation, routes of admin

27、istration and packaging;ISO 11240, Health informatics Identification of medicinal products Data elements and structures for the unique identification and exchange of units of measurement.These standards for the Identification of Medicinal Products (IDMP) support the activities of medicines regulator

28、y agencies worldwide by jurisdiction. These include a variety of regulatory activities related to development, registration and life cycle management of medicinal products, as well as pharmacovigilance and risk management.To meet the primary objectives of the regulation of medicines and pharmacovigi

29、lance, it is necessary to reliably exchange medicinal product information in a robust and reliable manner. The IDMP standards therefore support the following interactions (this is not an exhaustive list): regulator to regulator; pharmaceutical company to regulator; sponsor of clinical trial to regul

30、ator; regulator to other stakeholder; regulator to worldwide-maintained data sources.The necessary messaging specifications are included as an integral part of the IDMP standards to secure the interactions above.Unique identifiers produced in conformance with the IDMP standards are aimed to support

31、applications where it is necessary to reliably identify and trace the use of medicinal products.There are many terms in use to describe basic concepts in the regulatory, pharmaceutical and healthcare standards development domain for different purposes and in different contexts. The terms and definit

32、ions given in this International Standard are to be applied for the concepts which are required to uniquely identify, characterize and exchange regulated medicinal products and associated information.The terms and definitions adopted in this International Standard are intended to facilitate the inte

33、rpretation and application of legal and regulatory requirements but they are without prejudice to any legally binding document. In case of doubt or potential conflict, the terms and definitions contained in legally binding documents prevail.In the context of measurement terminology, currently there

34、are several alternative approaches possible for expressing units of measurement that can be used in a given instance. For purposes of electronic data exchange, it is therefore necessary to promote and encourage the adoption of a single standardized vocabulary that can be used as an international ref

35、erence for: unit concepts, ISO 2012 All rights reserved vBS EN ISO 11240:2012ISO 11240:2012(E) concept definitions, where applicable, and concept identifiers.This standardized vocabulary also needs to provide standardized structures that describe the mapping from and to the reference vocabulary, tak

36、ing into consideration the various approaches currently being applied. This helps to ensure that terms and identifiers currently used to represent units of measurement in the drug regulatory, pharmacovigilance and healthcare environments are mapped in a standardized and traceable way to the underlyi

37、ng metrological concepts, especially to the SI system of units. This will help ease implementation of this International Standard without impacting on the unit terms currently in use.The purpose of this International Standard is twofold:a) to address the issues outlined above by connecting to existi

38、ng unit vocabularies in current use;b) to facilitate electronic information exchange and interoperability that enables the unique and categorical identification of a medicinal product.Results of measurements are essential for the identification of medicinal products. However, often different ways ar

39、e used to express these results. The situation is further complicated by differences in the ways they are expressed in national legislation and in local administration. From the many available conventions, a consensus should therefore be reached on how to express the results of measurements on medic

40、inal products, particularly for exchange between information systems. Standardized structures are required in order to capture and exchange the terms representing the coded concepts for purposes of displaying and printing the concept representations in various languages suitable for human readabilit

41、y.Universal principles for the expression of measurements have been specified in the ISO 31, ISO 1000 and ISO 80000 series of standards, which implement the International System of Units (SI) defined by the General Conference on Weights and Measures. The implications of those standards are summarize

42、d in 4.2.Implementation of this International Standard will provide wider comprehension and interaction between countries and specialists in the field of medicinal product identification and pharmacovigilance.While the immediate scope is medicinal product identification, this International Standard

43、was designed with a rather general view on units of measurement. Therefore, it is also potentially applicable in other contexts.vi ISO 2012 All rights reservedBS EN ISO 11240:2012INTERNATIONAL STANDARD ISO 11240:2012(E)Health informatics Identification of medicinal products Data elements and structu

44、res for unique identification and exchange of units of measurement1 ScopeThis International Standard: specifies rules for the usage and coded representation of units of measurement for the purpose of exchanging information about quantitative medicinal product characteristics that require units of me

45、asurement (e.g. strength) in the human medicine domain; establishes requirements for units in order to provide traceability to international metrological standards; provides rules for the standardized and machine-readable documentation of quantitative composition and strength of medicinal products,

46、specifically in the context of medicinal product identification; defines the requirements for the representation of units of measurement in coded form; provides structures and rules for mapping between different unit vocabularies and language translations to support the implementation of this Intern

47、ational Standard, taking into account that existing systems, dictionaries and repositories use a variety of terms and codes for the representation of units.The scope of this International Standard is limited to the representation of units of measurement for data interchange between computer applicat

48、ions.2 Normative referencesThe following referenced documents are indispensable for the application 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 639 (all parts), Co

49、des for the representation of names of languagesISO 3166 (all parts), Codes for the representation of names of countries and their subdivisionsISO 11238, Health informatics Identification of medicinal products Data elements and structures for the unique identification and exchange of regulated information on substancesISO 11239, Health informatics Identification of medicinal products Data elements and structures for the unique identification and exchange of regulated information on pharmaceutical dose forms