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CEN

EN ISO 11238:2018

(Main)

Health informatics - Identification of medicinal products - Data elements and structures for the unique identification and exchange of regulated information on substances (ISO 11238:2018)

Health informatics - Identification of medicinal products - Data elements and structures for the unique identification and exchange of regulated information on substances (ISO 11238:2018)

This document provides an information model to define and identify substances within medicinal products or substances used for medicinal purposes, including dietary supplements, foods and cosmetics. The information model can be used in the human and veterinary domain since the principles are transferrable. Other standards and external terminological resources are referenced that are applicable to this document.

Medizinische Informatik - Identifikation von Arzneimitteln - Datenelemente und Strukturen zur eindeutigen Identifikation und zum Austausch von vorgeschriebenen Informationen zu Stoffen (ISO 11238:2018)

Informatique de santé - Identification des produits médicaux - Éléments de données et structures pour l'identification unique et l'échange d'informations réglementées sur les substances (ISO 11238:2018)

Le présent document donne un modèle d'informations visant à définir et identifier des substances utilisées dans des médicaments ou à des fins médicinales, y compris les compléments alimentaires, les produits alimentaires et les produits cosmétiques. Le modèle d'informations, qui repose sur des principes transférables, peut être utilisé aussi bien dans le domaine humain que vétérinaire. Il est fait référence à d'autres normes et ressources terminologiques externes applicables au présent document.

Zdravstvena informatika - Identifikacija medicinskih izdelkov - Elementi in zgradba podatkov za enotno identifikacijo in izmenjavo predpisanih informacij o substancah (ISO 11238:2018)

Ta dokument podaja informacijski model za opredelitev in identifikacijo substanc v medicinskih proizvodih ali substanc, ki se uporabljajo v medicinske namene, vključno s prehranskimi dopolnili, živili in kozmetičnimi proizvodi. Informacijski model je mogoče uporabljati za ljudi in živali, saj so načela prenosljiva. Omenjeni so tudi drugi standardi in zunanji terminološki viri, ki se nanašajo na ta dokument.

General Information

Status
Published
Publication Date
31-Jul-2018
Withdrawal Date
27-Feb-2019
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
01-Aug-2018
Completion Date
01-Aug-2018
Ref Project
SIST EN ISO 11238:2018 - Health informatics - Identification of medicinal products - Data elements and structures for the unique identification and exchange of regulated information on substances (ISO 11238:2018)

Relations

Replaces
EN ISO 11238:2012 - Health informatics - Identification of medicinal products - Data elements and structures for the unique identification and exchange of regulated information on substances (ISO 11238:2012)
Effective Date
02-Dec-2015

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SLOVENSKI STANDARD
SIST EN ISO 11238:2018
01-oktober-2018
1DGRPHãþD
SIST EN ISO 11238:2013
Zdravstvena informatika - Identifikacija medicinskih izdelkov - Elementi in zgradba
podatkov za enotno identifikacijo in izmenjavo predpisanih informacij o
substancah (ISO 11238:2018)
Health informatics - Identification of medicinal products - Data elements and structures
for the unique identification and exchange of regulated information on substances (ISO
11238:2018)
Medizinische Informatik - Identifikation von Arzneimitteln - Datenelemente und Strukturen
zur eindeutigen Identifikation und zum Austausch von vorgeschriebenen Informationen
zu Stoffen (ISO 11238:2018)
Informatique de santé - Identification des médicaments - Éléments de données et
structures pour l'identification unique et l'échange d'informations réglementées sur les
substances (ISO 11238:2018)
Ta slovenski standard je istoveten z: EN ISO 11238:2018
ICS:
35.240.80 Uporabniške rešitve IT v IT applications in health care
zdravstveni tehniki technology
SIST EN ISO 11238:2018 en,fr,de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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SIST EN ISO 11238:2018

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SIST EN ISO 11238:2018


EN ISO 11238
EUROPEAN STANDARD

NORME EUROPÉENNE

August 2018
EUROPÄISCHE NORM
ICS 35.240.80 Supersedes EN ISO 11238:2012
English Version

Health informatics - Identification of medicinal products -
Data elements and structures for the unique identification
and exchange of regulated information on substances (ISO
11238:2018)
Informatique de santé - Identification des produits Medizinische Informatik - Identifikation von
médicaux - Éléments de données et structures pour Arzneimitteln - Datenelemente und Strukturen zur
l'identification unique et l'échange d'informations eindeutigen Identifikation und zum Austausch von
réglementées sur les substances (ISO 11238:2018) vorgeschriebenen Informationen zu Stoffen (ISO
11238:2018)
This European Standard was approved by CEN on 24 July 2018.

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, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland,
Turkey 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
© 2018 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 11238:2018 E
worldwide for CEN national Members.

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SIST EN ISO 11238:2018
EN ISO 11238:2018 (E)
Contents Page
European foreword . 3

2

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SIST EN ISO 11238:2018
EN ISO 11238:2018 (E)
European foreword
This document (EN ISO 11238:2018) 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 February 2019, and conflicting national standards
shall be withdrawn at the latest by February 2019.
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 11238:2012.
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, Former Yugoslav Re
...

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