SIST EN ISO 11615:2018/A1:2023
(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)
No scope available
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)
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Standards Content (Sample)
SLOVENSKI STANDARD
SIST EN ISO 11615:2018/A1:2023
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
SIST EN ISO 11615:2018/A1:2023 en,fr,de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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SIST EN ISO 11615:2018/A1:2023
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SIST EN ISO 11615:2018/A1:2023
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.
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SIST EN ISO 11615:2018/A1:2023
EN ISO 11615:2017/A1:2022 (E)
Contents Page
European foreword . 3
2
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SIST EN ISO 11615:2018/A1:2023
EN ISO 11615:2017/A1:2022 (E)
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.
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SIST EN ISO 11615:2018/A1:2023
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SIST EN ISO 11615:2018/A1:2023
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)
© ISO 2022
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...
SLOVENSKI STANDARD
SIST EN ISO 11615:2018/oprA1:2021
01-december-2021
Zdravstvena informatika - Identifikacija zdravil - Elementi in zgradba podatkov za
enotno identifikacijo in izmenjavo predpisanih informacij o zdravilih - Dopolnilo A1
(ISO 11615:2017/DAM 1:2021)
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/DAM 1:2021)
Medizinische Informatik - Identifikation von Arzneimitteln - Datenelemente und
Strukturen zur eindeutigen Identifikation und zum Austausch von vorgeschriebenen
Arzneimittelinformationen - Änderung 1 (ISO 11615:2017/DAM 1:2021)
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/DAM 1:2021)
Ta slovenski standard je istoveten z: EN ISO 11615:2017/prA1
ICS:
11.120.10 Zdravila Medicaments
35.240.80 Uporabniške rešitve IT v IT applications in health care
zdravstveni tehniki technology
SIST EN ISO 11615:2018/oprA1:2021 en,fr,de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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SIST EN ISO 11615:2018/oprA1:2021
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SIST EN ISO 11615:2018/oprA1:2021
DRAFT AMENDMENT
ISO 11615:2017/DAM 1
ISO/TC 215 Secretariat: ANSI
Voting begins on: Voting terminates on:
2021-10-14 2022-01-06
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
ICS: 35.240.80
IMPORTANT — Please use this updated version dated 2021-08-18, and
discard any previous version of this DAM. The URN has been corrected.
THIS DOCUMENT IS A DRAFT CIRCULATED
This document is circulated as received from the committee secretariat.
FOR COMMENT AND APPROVAL. IT IS
THEREFORE SUBJECT TO CHANGE AND MAY
NOT BE REFERRED TO AS AN INTERNATIONAL
STANDARD UNTIL PUBLISHED AS SUCH.
IN ADDITION TO THEIR EVALUATION AS
ISO/CEN PARALLEL PROCESSING
BEING ACCEPTABLE FOR INDUSTRIAL,
TECHNOLOGICAL, COMMERCIAL AND
USER PURPOSES, DRAFT INTERNATIONAL
STANDARDS MAY ON OCCASION HAVE TO
BE CONSIDERED IN THE LIGHT OF THEIR
POTENTIAL TO BECOME STANDARDS TO
WHICH REFERENCE MAY BE MADE IN
Reference number
NATIONAL REGULATIONS.
ISO 11615:2017/DAM 1:2021(E)
RECIPIENTS OF THIS DRAFT ARE INVITED
TO SUBMIT, WITH THEIR COMMENTS,
NOTIFICATION OF ANY RELEVANT PATENT
RIGHTS OF WHICH THEY ARE AWARE AND TO
©
PROVIDE SUPPORTING DOCUMENTATION. ISO 2021
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SIST EN ISO 11615:2018/oprA1:2021
ISO 11615:2017/DAM 1:2021(E)
COPYRIGHT PROTECTED DOCUMENT
© ISO 2021
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
Email: copyright@iso.org
Website: www.iso.org
Published in Switzerland
ii © ISO 2021 – All rights reserved
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SIST EN ISO 11615:2018/oprA1:2021
ISO 11615:2017/DAM 1:2021(E)
Foreword
ISO (the International Organization for Standardization) is a worldwide federation of national standards
bodies (ISO member bodies). The work of preparing International Standards is normally carried out
through ISO technical committees. Each member body interested in a subject for which a technical
committee has been established has the right to be represented on that committee. International
organizations, governmental and non-governmental, in liaison with ISO, also take part in the work.
ISO collaborates closely with the International Electrotechnical Commission (IEC) on all matters of
electrotechnical standardization.
The procedures used to develop this document and those intended for its further maintenance are
described in the ISO/IEC Directives, Part 1. In particular, the different approval criteria needed for the
different types of ISO documents should be noted. This document was drafted in accordance with the
editorial rules of the ISO/IEC Directives, Part 2 (see www .iso .org/ directives).
Attention is drawn to the possibility that some of the elements of this document may be the subject of
pa
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