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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
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
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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.

Contents Page
European foreword . 3

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 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 the United Kingdom.
Endorsement notice
The text of ISO 11238:2018 has been approved by CEN as EN ISO 11238:2018 without any modification.

INTERNATIONAL ISO
STANDARD 11238
Second edition
2018-07
Health informatics — Identification
of medicinal products — Data
elements and structures for the
unique identification and exchange of
regulated information on substances
Informatique de santé — Identification des produits médicaux —
Eléments de données et structures pour l'identification unique et
l'échange d'informations réglementées sur les substances
Reference number
ISO 11238:2018(E)
©
ISO 2018
ISO 11238:2018(E)
© ISO 2018
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: +41 22 749 01 11
Fax: +41 22 749 09 47
Email: copyright@iso.org
Website: www.iso.org
Published in Switzerland
ii © ISO 2018 – All rights reserved

ISO 11238:2018(E)
Contents Page
Foreword .v
Introduction .vi
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Symbols and abbreviated terms .14
5 Description of the information modelling principles and practices .17
5.1 General considerations .17
5.2 Conceptual overview diagrams .17
5.3 Section high-level diagrams .18
5.4 Detailed diagrams.18
5.5 Relationships between classes .19
5.6 Notes .21
5.7 Attributes .21
5.8 Message exchange format .21
5.9 Conformance terminology and context as it relates to ISO 11238 and ISO/TS 19844 .22
6 Requirements .22
6.1 General .22
6.2 Concepts required for the unique identification and description of substances .22
6.3 Concepts required for the description of specified substances .24
6.3.1 Relationship between Substances and Specified Substance Groups .26
6.4 Naming of substances .27
6.5 Requirements for unique identifiers .28
6.6 Existing identifiers and molecular structure representation .28
7 Types of substances .29
7.1 General .29
7.2 Element sets common to multiple types of substances .29
7.2.1 Structure .29
7.2.2 Isotope .29
7.2.3 Modification .30
7.2.4 Reference information .31
7.2.5 Source material .32
7.2.6 Taxonomy .33
7.2.7 Authentication of Herbal Drugs .33
7.2.8 Substance codes .34
7.3 Chemical substances .34
7.4 Protein substances .35
7.5 Nucleic acid substances .37
7.6 Polymer substances .38
7.7 Structurally diverse substances .39
7.8 Mixture .42
8 Defining specified substances .43
8.1 General .43
8.2 Specified Substance Group 1 .
...

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