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

Status
Withdrawn
Publication Date
31-Oct-2012
Withdrawal Date
13-Jun-2023
Current Stage

Relations

Buy Standard

Standard
EN ISO 11239:2013
English language
37 pages
sale 10% off
Preview
sale 10% off
Preview
e-Library read for
1 day
Draft
prEN ISO 11239:2010
English language
35 pages
sale 10% off
Preview
sale 10% off
Preview
e-Library read for
1 day

Standards Content (Sample)

SLOVENSKI STANDARD
SIST EN ISO 11239:2013
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
SIST EN ISO 11239:2013 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

---------------------- Page: 1 ----------------------

SIST EN ISO 11239:2013

---------------------- Page: 2 ----------------------

SIST EN ISO 11239:2013


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.

---------------------- Page: 3 ----------------------

SIST EN ISO 11239:2013
EN ISO 11239:2012 (E)
Contents Page
Foreword .3

2

---------------------- Page: 4 ----------------------

SIST EN ISO 11239:2013
EN ISO 11239:2012 (E)
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 Ma
...

SLOVENSKI STANDARD
oSIST prEN ISO 11239:2010
01-november-2010
Zdravstvena informatika - Identifikacija medicinskih izdelkov - Elementi in zgradba
podatkov za enotno identifikacijo in izmenjavo predpisanih informacij na obrazcih
o farmacevtskih odmerkih, predstavitvenih enot in administrativnih poti (ISO/DIS
11239:2010)
Health informatics - Identification of medicinal products - Data elements and structures
for unique identification and exchange of regulated information on pharmaceutical dose
forms, units of presentation and routes of administration (ISO/DIS 11239:2010)
Medizinische Informatik - Identifikation von Arzneimitteln - Struktur und kontrollierte
Vokabularien für pharmazeutische Dosierungsformen, zusammengesetzten Einheiten in
Arzneiformen und Anwendungsarten (ISO/DIS 11239:2010)
Informatique de santé - Identification des produits médicaux - Éléments de données et
structures pour l'identification unique et l'échange d'informations réglementées
concernant les formes des doses pharmaceutiques, les unités de présentation et les
voies d'administration (ISO/DIS 11239:2010)
Ta slovenski standard je istoveten z: prEN ISO 11239
ICS:
35.240.80 Uporabniške rešitve IT v IT applications in health care
zdravstveni tehniki technology
oSIST prEN ISO 11239:2010 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

---------------------- Page: 1 ----------------------
oSIST prEN ISO 11239:2010

---------------------- Page: 2 ----------------------
oSIST prEN ISO 11239:2010


EUROPEAN STANDARD
DRAFT
prEN ISO 11239
NORME EUROPÉENNE

EUROPÄISCHE NORM

September 2010
ICS 35.240.80
English Version
Health informatics - Identification of medicinal products - Data
elements and structures for unique identification and exchange
of regulated information on pharmaceutical dose forms, units of
presentation and routes of administration (ISO/DIS 11239:2010)
Informatique de santé - Identification des produits Medizinische Informatik - Identifikation von Arzneimitteln -
médicaux - Éléments de données et structures pour Struktur und kontrollierte Vokabularien für pharmazeutische
l'identification unique et l'échange d'informations Dosierungsformen, zusammengesetzten Einheiten in
réglementées concernant les formes des doses Arzneiformen und Anwendungsarten (ISO/DIS 11239:2010)
pharmaceutiques, les unités de présentation et les voies
d'administration (ISO/DIS 11239:2010)
This draft European Standard is submitted to CEN members for parallel enquiry. It has been drawn up by the Technical Committee
CEN/TC 251.

If this draft becomes a European Standard, 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.

This draft European Standard was established by CEN 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 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, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom.


Warning : This document is not a European Standard. It is distributed for review and comments. It is subject to change without notice and
shall not be referred to as a European Standard.


EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION

EUROPÄISCHES KOMITEE FÜR NORMUNG

Management Centre: Avenue Marnix 17, B-1000 Brussels
© 2010 CEN All rights of exploitation in any form and by any means reserved Ref. No. prEN ISO 11239:2010: E
worldwide for CEN national Members.

---------------------- Page: 3 ----------------------
oSIST prEN ISO 11239:2010
prEN ISO 11239:2010 (E)
Contents Page
Foreword .3

2

---------------------- Page: 4 ----------------------
oSIST prEN ISO 11239:2010
prEN ISO 11239:2010 (E)
Foreword
This document (prEN ISO 11239:2010) 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 document is currently submitted to the parallel Enquiry.
Endorsement notice
The text of ISO/DIS 11239:2010 has been approved by CEN as a prEN ISO 11239:2010 without any
modification.

3

---------------------- Page: 5 ----------------------
oSIST prEN ISO 11239:2010

----------------------
...

Questions, Comments and Discussion

Ask us and Technical Secretary will try to provide an answer. You can facilitate discussion about the standard in here.