DIN EN ISO 11240-2013 Health informatics - Identification of medicinal products - Data elements and structures for unique identification and exchange of units of measurement (ISO 1.pdf

1、March 2013 Translation by DIN-Sprachendienst.English price group 22No part of this translation may be reproduced without prior permission ofDIN Deutsches Institut fr Normung e. V., Berlin. Beuth Verlag GmbH, 10772 Berlin, Germany,has the exclusive right of sale for German Standards (DIN-Normen).ICS

2、35.240.80!$P“1959445www.din.deDDIN EN ISO 11240Health informatics Identification of medicinal products Data elements and structures for the unique identification and exchangeof units of measurement (ISO 11240:2012);English version EN ISO 11240:2012,English translation of DIN EN ISO 11240:2013-03Medi

3、zinische Informatik Identifikation von Arzneimitteln Datenelemente, Struktur und kontrolliertes Vokabular fr Maeinheiten (ISO 11240:2012);Englische Fassung EN ISO 11240:2012,Englische bersetzung von DIN EN ISO 11240:2013-03Informatique de sant Identification des mdicaments lments de donnes et struct

4、ures pour lidentification unique et lchange dinformationssur les units de mesure (ISO 11240:2012);Version anglaise EN ISO 11240:2012,Traduction anglaise de DIN EN ISO 11240:2013-03www.beuth.deDocument comprises pagesIn case of doubt, the German-language original shall be considered authoritative.520

5、2.13DIN EN ISO 11240:2013-03 2 A comma is used as the decimal marker. National foreword This document (EN ISO 11240:2012) has been prepared by Technical Committee ISO/TC 215 “Health informatics” in collaboration with Technical Committee CEN/TC 251 “Health informatics” (Secretariat: NEN, Netherlands)

6、. The responsible German body involved in its preparation was the Normenausschuss Medizin (Medical Standards Committee), Working Committee NA 063-07-03 AA Terminologie of Section 7 Medizinische Informatik. The DIN Standards corresponding to the International Standards referred to in this document ar

7、e as follows: ISO 3166 (all parts) DIN EN ISO 3166-1, DIN EN ISO 3166-2 and DIN ISO 3166-3 ISO 9000 DIN EN ISO 9000 ISO 11238 DIN EN ISO 11238 ISO 11239 DIN EN ISO 11239 ISO 11615 DIN EN ISO 11615 ISO 11616 DIN EN ISO 11616 ISO 21090 DIN EN ISO 21090 ISO 27953-1 DIN EN ISO 27953-1 ISO 27953-2 DIN EN

8、 ISO 27953-2 ISO 80000 (all parts) DIN EN ISO 80000 DIN EN ISO 11240:2013-03 3 National Annex NA (informative) Bibliography DIN EN ISO 3166-1, Codes for the representation of names of countries and their subdivisions Part 1: Country codes DIN EN ISO 3166-2, Codes for the representation of names of c

9、ountries and their subdivisions Part 2: Country subdivision code DIN EN ISO 9000, Quality management systems Fundamentals and vocabulary DIN EN ISO 11238, Health informatics Identification of medicinal products Data elements and structures for the unique identification and exchange of regulated info

10、rmation on substances DIN EN 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 administration and packaging DIN EN ISO 1161

11、5, Health informatics Identification of medicinal products Data elements and structures for the unique identification and exchange of regulated medicinal product information DIN EN ISO 11616, Health informatics Identification of medicinal products Data elements and structures for unique identificati

12、on and exchange of regulated pharmaceutical product information DIN EN ISO 21090, Health Informatics Harmonized data types for information interchange DIN EN ISO 27953-1, Health informatics Individual case safety reports (ICSRs) in pharmacovigilance Part 1: Framework for adverse event reporting DIN

13、EN ISO 27953-2, Health informatics Individual case safety reports (ICSRs) in pharmacovigilance Part 2: Human pharmaceutical reporting requirements for ICSR DIN EN ISO 80000, Quantities and units (standards series) DIN EN ISO 3166-3, Information and documentation Codes for the representation of names

14、 of countries and their subdivisions Part 3: Code for formerly used names of countries DIN EN ISO 11240:2013-03 4 This page is intentionally blank EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN ISO 11240 November 2012 ICS 35.240.80 English Version Health informatics - Identification of medicin

15、al 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 structures pour lidentification unique et lchange dinformations sur les units de mesure (ISO 11240

16、: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 2012. CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulat

17、e 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 on application to the CEN-CENELEC Management Centre or to any CEN member. This European Stan

18、dard 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-CENELEC Management Centre has the same status as the official versions. CEN members are the nat

19、ional standards bodies of 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, Portugal, Romania, Sl

20、ovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and United Kingdom. EUROPEAN COMMITTEE FOR STANDARDIZATION COMIT EUROPEN DE NORMALISATION EUROPISCHES KOMITEE FR NORMUNG Management Centre: Avenue Marnix 17, B-1000 Brussels 2012 CEN All rights of exploitation in any form and by any means reserved

21、 worldwide for CEN national Members. Ref. No. EN ISO 11240:2012: EContents PageForeword .Introduction 1 Scope 2 Normative references .3 Terms, definitions and abbreviated terms 3.1 Terms and definitions .3.2 Abbreviations .4 Structures and vocabularies 4.1 Overview .4.2 Metrological concepts 4.3 Sem

22、antics of units of measurement 164.4 Vocabulary for units of measurement 174.5 Domain model 194.6 Data elements and technical data model 4.7 Operational attributes Annex A (informative) Using units of measurement for expression of medicinal product strength .Annex B (informative) Examples to describ

23、e data elements Annex C (informative) Example Controlled terminology mapping Annex D (informative) Domain analysis model Bibliography .DIN EN ISO 11240:2013-03 EN ISO 11240:2012 (E) 23466661213131321303233374250Foreword This document (EN ISO 11240:2012) has been prepared by Technical Committee ISO/T

24、C 215 “Health 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 20

25、13, and 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. A

26、ccording 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, Germ

27、any, Greece, 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

28、:2012 without any modification. DIN EN ISO 11240:2013-03 EN ISO 11240:2012 (E) 3 IntroductionThis International Standard was developed in response to a worldwide demand for internationally harmonized specifications for medicinal products. It is one of five standards which together provide the basis

29、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 information;ISO 11616, Health informatics Id

30、entification 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 identification and exchange of reg

31、ulated 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 administration and packaging;ISO 11240,

32、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 regulatory agencies worldwide by jurisdictio

33、n. 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 pharmacovigilance, it is necessary to reliably

34、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 regulator; regulator to other stakeholde

35、r; 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 applications where it is necessary

36、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 definitions given in this International St

37、andard 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 interpretation and application of legal

38、 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 are several alternative approaches

39、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 reference for: unit concepts,DIN EN IS

40、O 11240:2013-03 EN ISO 11240:2012 (E) 4 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, taking into consideration the various approaches currently

41、 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 underlying metrological concepts, especially to the SI system o

42、f 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 existing unit vocabularies in current use;b) to facilitate el

43、ectronic 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 are used to express these results. The situation is furth

44、er 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 medicinal products, particularly for exchange between inform

45、ation 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 readability.Universal principles for the expression of measuremen

46、ts 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 summarized in 4.2.Implementation of this International Standard

47、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 was designed with a rather general view on units of mea

48、surement. Therefore, it is also potentially applicable in other contexts.DIN EN ISO 11240:2013-03 EN ISO 11240:2012 (E) 5 1 ScopeThis International Standard: specifies rules for the usage and coded representation of units of measurement for the purpose of exchanging information about quantitative me

49、dicinal product characteristics that require units of measurement (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 quantitati