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CEN

EN ISO 11238:2012

(Main)

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

2011-07-20 ANP: Text received in ISO/CS (see notification from 2011-07-20 in dataservice).
2009-08-14 EMA: WI reinstated in ISO.
2009-07-16 SJ: Abandoned in ISO.

Medizinische Informatik - Identifikation von Arzneimitteln - Struktur und kontrollierte Vokabularien zur Identifikation und Beschreibung von Substanzen und Inhaltsstoffen (ISO 11238:2012)

Diese Internationale Norm stellt ein Informationsmodell zur Definition und Identifikation von in Arzneimitteln enthaltenen oder zu medizinischen Zwecken verwendeten Stoffen bereit, einschließlich Nahrungsergänzungsmittel, Lebens  und Futtermittelzusatzstoffe und Kosmetika. Es wird auf weitere Normen und externe Terminologiequellen verwiesen, die für diese Internationale Norm gelten.

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 11238:2012)

L'ISO 11238:2012 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, la nourriture et les produits cosmétiques.

Zdravstvena informatika - Identifikacija medicinskih izdelkov - Elementi in zgradba podatkov za enotno identifikacijo in izmenjavo predpisanih informacij o substancah (ISO 11238:2012)

Ta mednarodni standard zagotavlja informacijski model za določitev in identifikacijo substanc v medicinskih izdelkih ali substanc, ki se uporabljajo v medicinske namene, vključno s prehranskimi dopolnili, živili in kozmetičnimi proizvodi. Drugi navedeni standardi in zunanji terminološki viri se nanašajo na ta mednarodni standard.

General Information

Status
Withdrawn
Publication Date
31-Oct-2012
Withdrawal Date
31-Jul-2018
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
9960 - Withdrawal effective - Withdrawal
Completion Date
01-Aug-2018
Ref Project
SIST EN ISO 11238:2013 - Health informatics - Identification of medicinal products - Data elements and structures for the unique identification and exchange of regulated information on substances (ISO 11238:2012)

Relations

Replaced By
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)
Effective Date
02-Dec-2015

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SLOVENSKI STANDARD
SIST EN ISO 11238:2013
01-februar-2013
Zdravstvena informatika - Identifikacija medicinskih izdelkov - Elementi in zgradba
podatkov za enotno identifikacijo in izmenjavo predpisanih informacij o
substancah (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)
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Ta slovenski standard je istoveten z: EN ISO 11238:2012
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 11238:2013 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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SIST EN ISO 11238:2013

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SIST EN ISO 11238:2013


EUROPEAN STANDARD
EN ISO 11238

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 substances (ISO
11238:2012)
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
unique et l'échange d'informations réglementées sur les und Beschreibung von Substanzen und Inhaltsstoffen (ISO
substances (ISO 11238:2012) 11238:2012)
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 11238:2012: E
worldwide for CEN national Members.

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SIST EN ISO 11238:2013
EN ISO 11238:2012 (E)
Contents Page
Foreword .3

2

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

SIST EN ISO 11238:2013
EN ISO 11238:2012 (E)
Foreword
This document (EN ISO 11238:2012) 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,
...

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