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CEN ISO/TS 20443:2018

(Main)

Health informatics - Identification of medicinal products - Implementation guidelines for ISO 11615 data elements and structures for the unique identification and exchange of regulated medicinal product information (ISO/TS 20443:2017)

Health informatics - Identification of medicinal products - Implementation guidelines for ISO 11615 data elements and structures for the unique identification and exchange of regulated medicinal product information (ISO/TS 20443:2017)

ISO/TS 20443:2017 defines concepts and describes data elements and their structural relationships, which are required for the unique identification and the detailed description of Medicinal Products.
Taken together, all ISO IDMP standards (ISO 11615, ISO 11616, ISO 11238, ISO 11239 and ISO 11240) define, characterise, and uniquely identify regulated Medicinal Products for human use from approval, to post-marketing and renewal or withdrawal from the market, where applicable.
Furthermore, to support successful information exchange in relation to the unique identification and characterisation of Medicinal Products, the normative use of HL7 common product model (CPM) and structured product labeling (SPL) messaging is described. References to the use of other relevant standards for Medicinal Product information are included in ISO/TS 20443:2017 to support successful information exchange.

Medizinische Informatik - Identifikation von Arzneimitteln - Implementierungsleitfaden für ISO 11615 Datenelemente und Strukturen zur eindeutigen Identifikation und zum Austausch von vorgeschriebenen Arzneimittelinformationen (ISO/TS 20443:2017)

Informatique de santé - Identification des médicaments - Lignes directrices pour l’implémentation des éléments de données et structures ISO 11615 pour l’identification unique et l’échange d’informations réglementées sur les médicaments (ISO/TS 20443:2017)

Zdravstvena informatika - Identifikacija medicinskih izdelkov - Smernice za uporabo ISO 11615 podatkovnih elementov in struktur za enotno identifikacijo in izmenjavo predpisanih informacij o medicinskih izdelkih (ISO/TS 20443:2017)

Standard ISO/TS 20443:2017 določa opredelitve ter opisuje podatkovne elemente in njihove strukturne povezave, ki so potrebni za enotno identifikacijo in podroben opis medicinskih izdelkov.
Vsi standardi ISO IDMP (ISO 11615, ISO 11616, ISO 11238, ISO 11239 in ISO 11240) opredeljujejo, označujejo in enotno določajo predpisane medicinske izdelke za uporabo pri ljudeh od odobritve do poprodaje in podaljšanja ali umika s trga, kjer je to primerno.
Poleg tega je za podporo uspešne izmenjave informacij v zvezi z enotno identifikacijo in karakterizacijo medicinskih izdelkov opisana normativna uporaba splošnega modela za izdelke HL7 (CPM) in strukturiranega označevanja izdelkov (SPL). Sklici na uporabo drugih ustreznih standardov za informacije o medicinskih izdelkih so vključeni v standardu ISO/TS 20443:2017 z namenom podpore uspešne izmenjave informacij.

General Information

Status
Published
Publication Date
15-May-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
6060 - Definitive text made available (DAV) - Publishing
Start Date
16-May-2018
Due Date
09-Apr-2017
Completion Date
16-May-2018
Ref Project
SIST-TS CEN ISO/TS 20443:2018 - Health informatics - Identification of medicinal products - Implementation guidelines for ISO 11615 data elements and structures for the unique identification and exchange of regulated medicinal product information (ISO/TS 20443:2017)

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SLOVENSKI STANDARD
SIST-TS CEN ISO/TS 20443:2018
01-september-2018
Zdravstvena informatika - Identifikacija medicinskih izdelkov - Smernice za
uporabo ISO 11615 podatkovnih elementov in struktur za enotno identifikacijo in
izmenjavo predpisanih informacij o medicinskih izdelkih (ISO/TS 20443:2017)
Health informatics - Identification of medicinal products - Implementation guidelines for
ISO 11615 data elements and structures for the unique identification and exchange of
regulated medicinal product information (ISO/TS 20443:2017)
Medizinische Informatik - Identifikation von Arzneimitteln - Datenelemente und -
strukturen zur Identifikation von Arzneimitteln für den Austausch von behördlich
genehmigten Arzneimittelinformationen (ISO/TS 20443:2017)
Informatique de santé - Identification des médicaments - Lignes directrices pour
l’implémentation des éléments de données et structures ISO 11615 pour l’identification
unique et l’échange d’informations réglementées sur les médicaments (ISO/TS
20443:2017)
Ta slovenski standard je istoveten z: CEN ISO/TS 20443:2018
ICS:
35.240.80 Uporabniške rešitve IT v IT applications in health care
zdravstveni tehniki technology
SIST-TS CEN ISO/TS 20443:2018 en,fr,de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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SIST-TS CEN ISO/TS 20443:2018

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SIST-TS CEN ISO/TS 20443:2018


CEN ISO/TS 20443
TECHNICAL SPECIFICATION

SPÉCIFICATION TECHNIQUE

May 2018
TECHNISCHE SPEZIFIKATION
ICS 35.240.80
English Version

Health informatics - Identification of medicinal products -
Implementation guidelines for ISO 11615 data elements
and structures for the unique identification and exchange
of regulated medicinal product information (ISO/TS
20443:2017)
Informatique de santé - Identification des médicaments Medizinische Informatik - Identifikation von
- Lignes directrices pour l'implémentation des Arzneimitteln - Datenelemente und -strukturen zur
éléments de données et structures ISO 11615 pour Identifikation von Arzneimitteln für den Austausch von
l'identification unique et l'échange d'informations behördlich genehmigten Arzneimittelinformationen
réglementées sur les médicaments (ISO/TS (ISO/TS 20443:2017)
20443:2017)
This Technical Specification (CEN/TS) was approved by CEN on 13 May 2018 for provisional application.

The period of validity of this CEN/TS is limited initially to three years. After two years the members of CEN will be requested to
submit their comments, particularly on the question whether the CEN/TS can be converted into a European Standard.

CEN members are required to announce the existence of this CEN/TS in the same way as for an EN and to make the CEN/TS
available promptly at national level in an appropriate form. It is permissible to keep conflicting national standards in force (in
parallel to the CEN/TS) until the final decision about the possible conversion of the CEN/TS into an EN is reached.

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. CEN ISO/TS 20443:2018 E
worldwide for CEN national Members.

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SIST-TS CEN ISO/TS 20443:2018
CEN ISO/TS 20443:2018 (E)
Contents Page
European foreword . 3
Endorsement notice . 3

2

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SIST-TS CEN ISO/TS 20443:2018
CEN ISO/TS 20443:2018 (E)
European foreword
This document (CEN ISO/TS 20443:2018) 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.
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.
According to the CEN-CENELEC Internal Regulations, the national standards organizations of the
f
...

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