EN ISO 11239:2023

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 11239:2023)

This document specifies:
—     the data elements, 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 (containers, closures and administration devices) related to medicinal products;
—     a mechanism for the association of translations of a single concept into different languages, which is an integral part of the information exchange;
—     a mechanism for the versioning of the concepts in order to track their evolution;
—     rules to help regional authorities to map existing regional terms to the terms created using this document, in a harmonized and meaningful way.

Medizinische Informatik - Identifikation von Arzneimitteln - Datenelemente und -strukturen zur Identifikation von pharmazeutischen Darreichungsformen, pharmazeutischen Konventionseinheiten, Anwendungsarten und Verpackungen (ISO 11239:2023)

Dieses Dokument 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, die regionalen Behörden helfen sollen, bestehende regionale Benennungen auf harmonisierte und sinnvolle Weise den mit diesem Dokument erstellten Benennungen zuzuordnen.

Informatique de santé - Identification des médicaments - Éléments de données et structures pour l'identification unique et l'échange d'informations réglementées sur les formes pharmaceutiques, les unités de présentation, les voies d'administration et les emballages (ISO 11239:2023)

Le présent document 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 médicaments;
—     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 aidant les autorités régionales à procéder à la mise en correspondance harmonisée et significative des termes régionaux existants avec les termes créés à l'aide du présent document.

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 11239:2023)

Ta dokument določa:
–    podatkovne elemente, strukture in odnose med podatkovnimi elementi, ki so potrebni za izmenjavo informacij ter ki na edinstven in zanesljiv način določajo oblike farmacevtskih odmerkov, predstavitvene enote, načine dajanja in embalažo (vsebniki, zapirala in pripomočki za dajanje), ki so povezani z zdravili;
–     mehanizem za povezovanje prevodov istega koncepta v različne jezike, kar je nujen del izmenjave informacij;
–     mehanizem za shranjevanje različic konceptov, da se omogoči sledenje njihovemu razvoju;
–     pravila, ki regionalnim organom pomagajo pri usklajenem in smiselnem povezovanju regionalnih izrazov z izrazi, ustvarjenimi s pomočjo tega dokumenta.

General Information

• Status: Published
• Publication Date: 13-Jun-2023
• ICS: 35.240.80 - IT applications in health care technology
• Technical Committee: CEN/TC 251 - Medical informatics
• Drafting Committee: CEN/TC 251/WG 1 - Information models
• Current Stage: 6060 - Definitive text made available (DAV) - Publishing
• Start Date: 14-Jun-2023
• Completion Date: 14-Jun-2023
• Ref Project: SIST EN ISO 11239:2023 - 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 11239:2023)

Relations

• Replaces: EN 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)
• Effective Date: 18-Jan-2023

Standards Content (Sample)

SLOVENSKI STANDARD
01-september-2023
Nadomešča:
SIST EN ISO 11239:2013
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 11239:2023)
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
11239:2023)
Medizinische Informatik - Identifikation von Arzneimitteln - Datenelemente und -
strukturen zur Identifikation von pharmazeutischen Darreichungsformen,
pharmazeutischen Konventionseinheiten, Anwendungsarten und Verpackungen (ISO
11239:2023)
Informatique de santé - Identification des médicaments - Éléments de données et
structures pour l'identification unique et l'échange d'informations réglementées sur les
formes pharmaceutiques, les unités de présentation, les voies d'administration et les
emballages (ISO 11239:2023)
Ta slovenski standard je istoveten z: EN ISO 11239:2023
ICS:
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.

EN ISO 11239
EUROPEAN STANDARD
NORME EUROPÉENNE
June 2023
EUROPÄISCHE NORM
ICS 35.240.80 Supersedes EN ISO 11239:2012
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 11239:2023)
Informatique de santé - Identification des médicaments Medizinische Informatik - Identifikation von
- Éléments de données et structures pour Arzneimitteln - Datenelemente und -strukturen zur
l'identification unique et l'échange d'informations Identifikation von pharmazeutischen
réglementées sur les formes pharmaceutiques, les Darreichungsformen, pharmazeutischen
unités de présentation, les voies d'administration et les Konventionseinheiten, Anwendungsarten und
emballages (ISO 11239:2023) Verpackungen (ISO 11239:2023)
This European Standard was approved by CEN on 9 May 2023.

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, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway,
Poland, Portugal, Republic of North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Türkiye and
United Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION

EUROPÄISCHES KOMITEE FÜR NORMUNG

CEN-CENELEC Management Centre: Rue de la Science 23, B-1040 Brussels
© 2023 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 11239:2023 E
worldwide for CEN national Members.

Contents Page
European foreword . 3

European foreword
This document (EN ISO 11239:2023) 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 December 2023, and conflicting national standards
shall be withdrawn at the latest by December 2023.
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. CEN shall not be held responsible for identifying any or all such patent rights.
This document supersedes EN ISO 11239:2012.

Any feedback and questions on this document should be directed to the users’ national standards
body/national committee. A complete listing of these bodies can be found on the CEN website.
According to the CEN-CENELEC Internal Regulations, the national standards organizations of the
following countries are bound to implement this European Standard: Austria, Belgium, Bulgaria,
Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland,
Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Republic of
North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Türkiye and the
United Kingdom.
Endorsement notice
The text of ISO 11239:2023 has been approved by CEN as EN ISO 11239:2023 without any modification.

INTERNATIONAL ISO
STANDARD 11239
Second edition
2023-06
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 pharmaceutiques, les
unités de présentation, les voies d'administration et les emballages
Reference number
ISO 11239:2023(E)
ISO 11239:2023(E)
© ISO 2023
All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may
be reproduced or utilized otherwise in any form or by any means, electronic or mechanical, including photocopying, or posting on
the internet or an intranet, without prior written permission. Permission can be requested from either ISO at the address below
or ISO’s member body in the country of the requester.
ISO copyright office
CP 401 • Ch. de Blandonnet 8
CH-1214 Vernier, Geneva
Phone: [phone]
Email: [e-mail]
Website: www.iso.org
Published in Switzerland
ii
ISO 11239:2023(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 Abbreviated terms . 6
4 Requirements . 7
4.1 General information regarding controlled vocabularies . 7
4.2 Requirements for use . 7
5 Schema . 7
5.1 General . 7
5.2 Conceptual models — Supporting concepts . 8
5.2.1 General . 8
5.2.2 Terms and codes . 8
5.3 Conceptual models — High-level concepts . 11
5.3.1 General . 11
5.3.2 Pharmaceutical dose form . 11
5.3.3 Unit of presentation .15
5.3.4 Route of administration . 16
5.3.5 Packaging . 17
Annex A (informative) Examples of controlled vocabularies .18
Annex B (informative) Examples of controlled vocabularies to describe medicinal products .24
Bibliography .29
iii
ISO 11239:2023(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.
The procedures used to develop this document and those intended for its further maintenance are
described in the ISO/IEC Directives, Part 1. In particular, the different approval criteria needed for the
different types of ISO document 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).
ISO draws attention to the possibility that the implementation of this document may involve the use
of (a) patent(s). ISO takes no position concerning the evidence, validity or applicability of any claimed
patent rights in respect thereof. As of the date of publication of this document, ISO had not received
notice of (a) patent(s) which may be required to implement this document. However, implementers are
cautioned that this may not represent the latest information, which may be obtained from the patent
database available at  www.iso.org/patents. ISO shall not be held responsible for identifying any or all
such patent rights.
Any trade name used in this document is information given for the convenience of users and does not
constitute an endorsement.
For an explanation of the voluntary nature of standards, the meaning of ISO specific terms and
expressions related to conformity assessment, as well as information about ISO's adherence to
the World Trade Organization (WTO) principles in the Technical Barriers to Trade (TBT), see
www.iso.org/iso/foreword.html.
This document was prepared by Technical Committee ISO/TC 215, Health informatics, in collaboration
with the European Committee for Standardization (CEN) Technical Committee CEN/TC 251, Health
informatics, in accordance with the Agreement on technical cooperation between ISO and CEN (Vienna
Agreement).
This second edition cancels and replaces the first edition (ISO 11239:2012), which has
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