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CEN

EN ISO 11615:2017/A1:2022

(Amendment)

Health informatics - Identification of medicinal products - Data elements and structures for the unique identification and exchange of regulated medicinal product information - Amendment 1 (ISO 11615:2017/Amd 1:2022)

Health informatics - Identification of medicinal products - Data elements and structures for the unique identification and exchange of regulated medicinal product information - Amendment 1 (ISO 11615:2017/Amd 1:2022)

Medizinische Informatik - Identifikation von Arzneimitteln - Datenelemente und Strukturen zur eindeutigen Identifikation und zum Austausch von vorgeschriebenen Arzneimittelinformationen - Änderung 1 (ISO 11615:2017/Amd 1:2022)

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Informatique de santé - Identification des médicaments - Éléments de données et structures pour l'identification unique et l'échange d'informations sur les médicaments contrôlés - Amendement 1 (ISO 11615:2017/Amd 1:2022)

Zdravstvena informatika - Identifikacija zdravil - Elementi in zgradba podatkov za enotno identifikacijo in izmenjavo predpisanih informacij o zdravilih - Dopolnilo A1 (ISO 11615:2017/Amd 1:2022)

General Information

Status
Published
Publication Date
20-Sep-2022
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
21-Sep-2022
Completion Date
21-Sep-2022
Ref Project
SIST EN ISO 11615:2018/A1:2023 - Health informatics - Identification of medicinal products - Data elements and structures for the unique identification and exchange of regulated medicinal product information - Amendment 1 (ISO 11615:2017/Amd 1:2022)

Relations

Amends
EN ISO 11615:2017 - Health informatics - Identification of medicinal products - Data elements and structures for the unique identification and exchange of regulated medicinal product information (ISO 11615:2017)
Effective Date
03-Jun-2020

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SLOVENSKI STANDARD
01-januar-2023
Zdravstvena informatika - Identifikacija zdravil - Elementi in zgradba podatkov za
enotno identifikacijo in izmenjavo predpisanih informacij o zdravilih - Dopolnilo A1
(ISO 11615:2017/Amd 1:2022)
Health informatics - Identification of medicinal products - Data elements and structures
for the unique identification and exchange of regulated medicinal product information -
Amendment 1 (ISO 11615:2017/Amd 1:2022)
Medizinische Informatik - Identifikation von Arzneimitteln - Datenelemente und Strukturen
zur eindeutigen Identifikation und zum Austausch von vorgeschriebenen
Arzneimittelinformationen - Änderung 1 (ISO 11615:2017/Amd 1:2022)
Informatique de santé - Identification des médicaments - Éléments de données et
structures pour l'identification unique et l'échange d'informations sur les médicaments
contrôlés - Amendement 1 (ISO 11615:2017/Amd 1:2022)
Ta slovenski standard je istoveten z: EN ISO 11615:2017/A1:2022
ICS:
11.120.10 Zdravila Medicaments
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 11615:2017/A1
EUROPEAN STANDARD
NORME EUROPÉENNE
September 2022
EUROPÄISCHE NORM
ICS 35.240.80
English Version
Health informatics - Identification of medicinal products -
Data elements and structures for the unique identification
and exchange of regulated medicinal product information -
Amendment 1 (ISO 11615:2017/Amd 1:2022)
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 sur eindeutigen Identifikation und zum Austausch von
les médicaments contrôlés - Amendement 1 (ISO vorgeschriebenen Arzneimittelinformationen -
11615:2017/Amd 1:2022) Änderung 1 (ISO 11615:2017/Amd 1:2022)
This amendment A1 modifies the European Standard EN ISO 11615:2017; it was approved by CEN on 12 August 2022.

CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for inclusion of
this amendment into the relevant 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 amendment 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
© 2022 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 11615:2017/A1:2022 E
worldwide for CEN national Members.

Contents Page
European foreword . 3

European foreword
This document (EN ISO 11615:2017/A1:2022) 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 Amendment to the European Standard EN ISO 11615:2017 shall be given the status of a national
standard, either by publication of an identical text or by endorsement, at the latest by March 2023, and
conflicting national standards shall be withdrawn at the latest by March 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.
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 11615:2017/Amd 1:2022 has been approved by CEN as EN ISO 11615:2017/A1:2022
without any modification.
INTERNATIONAL ISO
STANDARD 11615
Second edition
2017-10
AMENDMENT 1
2022-08
Health informatics — Identification
of medicinal products — Data
elements and structures for the
unique identification and exchange
of regulated medicinal product
information
AMENDMENT 1
Informatique de santé — Identification des médicaments — Éléments
de données et structures pour l'identification unique et l'échange
d'informations sur les médicaments contrôlés
AMENDEMENT 1
Reference number
ISO 11615:2017/Amd.1:2022(E)
------
...

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