EN ISO 11240:2012
(Main)Health informatics - Identification of medicinal products - Data elements and structures for the unique identification and exchange of units of measurement (ISO 11240:2012)
Health informatics - Identification of medicinal products - Data elements and structures for the unique identification and exchange of units of measurement (ISO 11240:2012)
ISO 11240:2012:
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 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 quantitative composition and strength of medicinal products, 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 ISO 11240:2012, taking into account that existing systems, dictionaries and repositories use a variety of terms and codes for the representation of units.
The scope of ISO 11240:2012 is limited to the representation of units of measurement for data interchange between computer applications.
Medizinische Informatik - Identifikation von Arzneimitteln - Datenelemente, Struktur und kontrolliertes Vokabular für Maßeinheiten (ISO 11240:2012)
Diese Internationale Norm:
- legt Regeln für die Verwendung und kodierte Repräsentation von Maßeinheiten fest für den Austausch
von Informationen zu quantitativen Arzneimittelmerkmalen (z. B. Stärke) im Bereich der Humanmedizin,
bei denen die Angabe von Maßeinheiten erforderlich ist;
- stellt Anforderungen an Einheiten auf, um eine Rückführung auf internationale metrologische Normale zu
ermöglichen;
- gibt Regeln an für die genormte und maschinenlesbare Dokumentation der quantitativen Zusammensetzung
und Stärke von Arzneimitteln, vor allem im Zusammenhang mit der Arzneimittel-Identifikation;
- definiert die Anforderungen an die Repräsentation von Maßeinheiten in kodierter Form;
- stellt Strukturen und Regeln bereit, um unterschiedliche Vokabularien und Übersetzungen im
Zusammenhang mit Einheiten aufeinander abbilden zu können und so die Implementierung dieser Norm
zu unterstützen, wobei berücksichtigt wird, dass bestehende Systeme, Wörterbücher und Verzeichnisse
eine Vielzahl von Benennungen und Codes für die Darstellung von Einheiten anwenden.
Der Anwendungsbereich dieser Norm ist auf die Repräsentation von Maßeinheiten zum Datenaustausch
zwischen Rechneranwendungen begrenzt.
Informatique de santé - Identification des médicaments - Éléments de données et structures pour l'identification unique et l'échange d'informations sur les unités de mesure (ISO 11240:2012)
Zdravstvena informatika - Identifikacija medicinskih izdelkov - Elementi in zgradba podatkov za enotno identifikacijo in izmenjavo merilnih enot (ISO 11240:2012)
Ta mednarodni standard: – določa pravila za uporabo in kodirano predstavitev merskih enot za izmenjavo informacij o kvantitativnih lastnostih medicinskih izdelkov, za katere so potrebne merilne enote (npr. moč) na področju zdravil za ljudi; – vzpostavlja zahteve za enote, da se zagotovi sledljivost mednarodnih meroslovnih standardov; – zagotavlja pravila za standardizirano in strojno berljivo dokumentacijo količinske sestave in moči medicinskih izdelkov, zlasti v smislu identifikacije medicinskih izdelkov; – določa zahteve za predstavitev merilnih enot v kodirani obliki; – zagotavlja strukture in pravila za preslikavanje med slovarji in jezikovnimi prevodi različnih enot za podporo uporabe tega mednarodnega standarda, pri čemer se upošteva, da se v obstoječih sistemih, slovarjih in virih uporabljajo različni izrazi in kode za predstavitev enot. Področje uporabe tega mednarodnega standarda je omejeno na predstavitev merilnih enot za izmenjavo podatkov med računalniškimi aplikacijami.
General Information
Standards Content (Sample)
SLOVENSKI STANDARD
01-februar-2013
Zdravstvena informatika - Identifikacija medicinskih izdelkov - Elementi in zgradba
podatkov za enotno identifikacijo in izmenjavo merilnih enot (ISO 11240:2012)
Health informatics - Identification of medicinal products - Data elements and structures
for the unique identification and exchange of units of measurement (ISO 11240:2012)
Medizinische Informatik - Identifikation von Arzneimitteln - Datenelemente, Struktur und
kontrolliertes Vokabular für Maßeinheiten (ISO 11240:2012)
Informatique de santé - Identification des médicaments - Éléments de données et
structures pour l'identification unique et l'échange d'informations sur les unités de
mesure (ISO 11240:2012)
Ta slovenski standard je istoveten z: EN ISO 11240:2012
ICS:
11.020 0HGLFLQVNHYHGHLQ Medical sciences and health
]GUDYVWYHQRYDUVWYHQL care facilities in general
SULSRPRþNLQDVSORãQR
35.240.80 Uporabniške rešitve IT v IT applications in health care
zdravstveni tehniki technology
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
EUROPEAN STANDARD
EN ISO 11240
NORME EUROPÉENNE
EUROPÄISCHE NORM
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 santé - Identification des médicaments - Medizinische Informatik - Identifikation von Arzneimitteln -
Éléments de données et structures pour l'identification Datenelemente, Struktur und kontrolliertes Vokabular für
unique et l'échange d'informations sur les unités de mesure Maßeinheiten (ISO 11240:2012)
(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 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 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-CENELEC 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, Italy, Latvia, Lithuania,
Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and United
Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION
EUROPÄISCHES KOMITEE FÜR NORMUNG
Management Centre: Avenue Marnix 17, B-1000 Brussels
© 2012 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 11240:2012: E
worldwide for CEN national Members.
Contents Page
Foreword .3
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” 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 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 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, 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 11240:2012 without any modification.
INTERNATIONAL ISO
STANDARD 11240
First edition
2012-11-01
Health informatics — Identification of
medicinal products — Data elements and
structures for the unique identification
and exchange of units of measurement
Informatique de santé — Identification des médicaments — Éléments
de données et structures pour l’identification unique et l’échange
d’informations sur les unités de mesure
Reference number
ISO 11240:2012(E)
©
ISO 2012
ISO 11240:2012(E)
All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized in any form or by any means,
electronic or mechanical, including photocopying and microfilm, without permission in writing from either ISO at the address below or ISO’s
member body in the country of the requester.
ISO copyright office
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Tel. + 41 22 749 01 11
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Published in Switzerland
ii © ISO 2012 – All rights reserved
ISO 11240:2012(E)
Contents Page
Foreword .iv
Introduction . v
1 Scope . 1
2 Normative references . 1
3 Terms, definitions and abbreviated terms . 1
3.1 Terms and definitions . 1
3.2 Abbreviations . 7
4 Structures and vocabularies . 8
4.1 Overview . 8
4.2 Metrological concepts . 8
4.3 Semantics of units of measurement . 11
4.4 Vocabulary for units of measurement .12
4.5 Domain model .14
4.6 Data elements and technical data model .16
4.7 Operational attributes .25
Annex A (informative) Using units of measurement for expression of medicinal product strength .27
Annex B (informative) Examples to describe data elements .28
Annex C (informative) Example — Controlled terminology mapping .32
Annex D (informative) Domain analysis model .37
Bibliography .45
ISO 11240:2012(E)
Foreword
ISO (the International Organization for Standardization) is a worldwide 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 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 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 Standard 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 Technical Committee ISO/TC 215, Health informatics.
iv © ISO 2012 – All rights reserved
ISO 11240:2012(E)
Introduction
This 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 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 — 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 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 administration 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
regulatory 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 pharmacovigilance, 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 regulator;
— 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 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 definitions
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 interpretation 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 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 reference for:
— unit concepts,
...
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