EN ISO 11239:2012
(Main)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 11239:2012)
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 11239:2012)
ISO 11239:2012 specifies:
· the structures and relationships between the data elements required for the exchange of information, which uniquely and with certainty identify pharmaceutical dose forms, units of presentation, routes of administration and packaging items related to medicinal products;
· a mechanism for the association of translations of a single concept into different languages;
· a mechanism for the versioning of the concepts in order to track their evolution;
· rules to allow regional authorities to map existing regional terms to the terms created using ISO 11239:2012 in a harmonized and meaningful way.
Medizinische Informatik - Identifikation von Arzneimitteln - Struktur und kontrollierte Vokabularien zur Identifikation von pharmazeutischen Darreichungsformen, pharmazeutischen Konventionseinheiten, Anwendungsarten und Verpackungen (ISO 11239:2012)
Diese Internationale Norm legt:
- Datenelemente und strukturen sowie Beziehungen zwischen den Datenelementen , die für den Austausch von Informationen erforderlich sind, mit denen pharmazeutische Dosierungsformen, Bereitstellungseinheiten, Verabreichungswege und Verpackungsartikel (Behältnisse, Verschlüsse und Verabreichungsvorrichtungen) im Zusammenhang mit Arzneimitteln eindeutig und sicher identifiziert werden können, fest;
- einen Mechanismus fest zur Übersetzung der Benennungen aus dem Englischen in weitere Sprachen, was einen festen Bestandteil des Informationsaustausches darstellt;
- einen Mechanismus für die Versionierung der Begriffe fest, um ihre Entwicklung verfolgen zu können;
- Regeln fest, um es regionalen Behörden zu ermöglichen, bestehende regionale Benennungen auf die mit Hilfe dieser Norm erzeugten Benennungen abzubilden, und zwar in einer harmonisierten und sinntragenden Weise.
Darüber hinaus wird zwecks Unterstützung einer erfolgreichen Anwendung dieser Internationalen Norm gegebenenfalls auf weitere Normen zur Identifikation von Arzneimitteln (IDMP) und zur Übermittlung von Informationen zu Arzneimitteln verwiesen.
Informatique de santé - Identification des médicaments - Éléments de données et structures pour l'identification unique et l'échange d'informations réglementées sur les formes des doses pharmaceutiques, les unités de présentation, les voies d'administration et les emballages (ISO 11239:2012)
L'ISO 11239:2012 spécifie
les éléments de données, les structures et les relations entre les éléments de données nécessaires à l'échange des informations qui identifient de manière unique et avec certitude les formes pharmaceutiques, les unités de présentation, les voies d'administration et les emballages (conteneurs, systèmes de fermeture et dispositifs d'administration) liés aux produits médicaux,
un mécanisme permettant d'associer les traductions d'un concept élémentaire en différentes langues, ce qui fait partie intégrante de l'échange d'informations,
un mécanisme permettant de contrôler les versions des concepts afin de suivre leur évolution, et
les règles permettant aux autorités régionales de procéder à la mise en correspondance harmonisée et significative des termes régionaux existants avec les termes créés à l'aide de l'ISO 11239:2012.
Zdravstvena informatika - Identifikacija medicinskih izdelkov - Elementi in zgradba podatkov za enotno identifikacijo in izmenjavo predpisanih informacij na obrazcih o farmacevtskih odmerkih, predstavitvenih enotah, administrativnih poteh in pakiranju (ISO 11239:2012)
Ta mednarodni standard določa: – podatkovne elemente, strukture in povezave med podatkovnimi elementi, potrebnimi za izmenjavo informacij, ki enoznačno in zanesljivo prepoznavajo obrazce o farmacevtskih odmerkih, predstavitvene enote, administrativne poti in dele embalaže (posode, pokrovčki in naprave za doziranje) v zvezi z zdravili; – mehanizem za povezovanje prevodov posameznega koncepta v različne jezike, kar je sestavni del izmenjave informacij; – mehanizem za ustvarjanje različic konceptov za sledenje njihovemu razvoju; – pravila za dovoljenje regionalnih organov, da na usklajen in smiseln način preslikajo obstoječe regionalne izraze v izraze, ustvarjene z uporabo mednarodnega standarda. Poleg tega so v podporo uspešni uporabi tega mednarodnega standarda navedeni sklici na standarde, ki zadevajo identifikacijo medicinskih izdelkov (IDMP) in sporočanje informacij o medicinskih izdelkih.
General Information
Relations
Standards Content (Sample)
SLOVENSKI STANDARD
01-februar-2013
Zdravstvena informatika - Identifikacija medicinskih izdelkov - Elementi in zgradba
podatkov za enotno identifikacijo in izmenjavo predpisanih informacij na obrazcih
o farmacevtskih odmerkih, predstavitvenih enotah, administrativnih poteh in
pakiranju (ISO 11239:2012)
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
11239:2012)
Medizinische Informatik - Identifikation von Arzneimitteln - Struktur und kontrollierte
Vokabularien zur Identifikation von pharmazeutischen Darreichungsformen,
pharmazeutischen Konventionseinheiten und Anwendungsarten (ISO 11239:2012)
Informatique de santé - Identification des médicaments - Éléments de données et
structures pour l'identification unique et l'échange d'informations réglementées sur les
formes des doses pharmaceutiques, les unités de présentation, les voies
d'administration et les emballages (ISO 11239:2012)
Ta slovenski standard je istoveten z: EN ISO 11239:2012
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 11239
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 regulated information on pharmaceutical dose
forms, units of presentation, routes of administration and
packaging (ISO 11239:2012)
Informatique de santé - Identification des médicaments - Medizinische Informatik - Identifikation von Arzneimitteln -
Éléments de données et structures pour l'identification Struktur und kontrollierte Vokabularien zur Identifikation von
unique et l'échange d'informations réglementées sur les pharmazeutischen Darreichungsformen, pharmazeutischen
formes des doses pharmaceutiques, les unités de Konventionseinheiten, Anwendungsarten und
présentation, les voies d'administration et les emballages Verpackungen (ISO 11239:2012)
(ISO 11239:2012)
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 11239:2012: E
worldwide for CEN national Members.
Contents Page
Foreword .3
Foreword
This document (EN ISO 11239:2012) 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 11239:2012 has been approved by CEN as a EN ISO 11239:2012 without any modification.
INTERNATIONAL ISO
STANDARD 11239
First edition
2012-11-01
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
Informatique de santé — Identification des médicaments —
Éléments de données et structures pour l’identification unique et
l’échange d’informations réglementées sur les formes des doses
pharmaceutiques, les unités de présentation, les voies d’administration
et les emballages
Reference number
ISO 11239:2012(E)
©
ISO 2012
ISO 11239:2012(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
Case postale 56 • CH-1211 Geneva 20
Tel. + 41 22 749 01 11
Fax + 41 22 749 09 47
E-mail copyright@iso.org
Web www.iso.org
Published in Switzerland
ii © ISO 2012 – All rights reserved
ISO 11239:2012(E)
Contents Page
Foreword .iv
Introduction . v
1 Scope . 1
2 Normative references . 1
3 Terms, definitions and abbreviations . 1
3.1 Terms and definitions . 1
3.2 Abbreviations . 5
4 Requirements . 6
4.1 General requirements for controlled vocabularies . 6
4.2 Requirements for use within the IDMP set of standards . 7
5 Schema . 7
5.1 General . 7
5.2 Conceptual models — Supporting concepts . 8
5.3 Conceptual models — High-level concepts .10
Annex A (informative) Examples of controlled vocabularies .17
Annex B (informative) Examples of controlled vocabularies to describe medicinal products .23
Bibliography .28
ISO 11239:2012(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 11239 was prepared by Technical Committee ISO/TC 215, Health informatics.
iv © ISO 2012 – All rights reserved
ISO 11239:2012(E)
Introduction
This International Standard was developed in response to a worldwide demand for internationally harmonized
specifications for medicinal products. It is one of a group 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 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 stakeholders;
— 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 at supporting 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
described in this International Standard are to be applied for the concepts which are required in order 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 conte
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