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CEN ISO/TS 20451:2018

(Main)

Health informatics - Identification of medicinal products - Implementation guidelines for ISO 11616 data elements and structures for the unique identification and exchange of regulated pharmaceutical product information (ISO/TS 20451:2017)

Health informatics - Identification of medicinal products - Implementation guidelines for ISO 11616 data elements and structures for the unique identification and exchange of regulated pharmaceutical product information (ISO/TS 20451:2017)

ISO/TS 20451:2017 defines the concepts required to associate pharmaceutical products with an appropriate set of PhPID(s) in accordance with ISO 11616.
Pharmaceutical identifiers and elements are to represent pharmaceutical products as represented in a Medicinal Product as indicated by a Medicines Regulatory Authority. The suite of ISO IDMP standards can be applied to off-label usage of Medicinal Products, but is currently outside of the scope of ISO/TS 20451:2017.
Reference to ISO 11238, ISO 11239, ISO 11240 and ISO 11615 and HL7 messaging standards, HL7 Reference Information Model (RIM), HL7 V3 Common Product Model (CPM) and HL7 V3 Structured Product Labelling (SPL) can be applied for pharmaceutical product information in the context of ISO/TS 20451:2017.

Medizinische Informatik - Identifikation von Arzneimitteln - Implementierungsleitfaden für ISO 11616 Datenelemente und -strukturen zur eindeutigen Identifikation und zum Austausch von Informationen über pharmazeutische Produkte (ISO/TS 20451:2017)

Informatique de santé - Identification des médicaments - Lignes directrices pour l’implémentation des éléments de données et structures ISO 11616 pour l’identification unique et l’échange d’informations réglementées sur les produits pharmaceutiques (ISO/TS 20451:2017)

Zdravstvena informatika - Identifikacija medicinskih izdelkov - Smernice za uporabo ISO 11616 podatkovnih elementov in struktur za enotno identifikacijo in izmenjavo predpisanih informacij o farmacevtskih izdelkih (ISO/TS 20451:2017)

Standard ISO/TS 20451:2017 določa opredelitve, ki so potrebne za povezavo farmacevtskih izdelkov z ustreznim naborom PhPID-jev v skladu s standardom ISO 11616.
Namen farmacevtskih identifikatorjev in elementov je predstaviti farmacevtske izdelke, kot so predstavljeni v medicinskem izdelku in kot to določa Regulativni organ za zdravila (MRA). Zbirka standardov ISO IDMP se lahko uporabi za izjemno uporabo medicinskih izdelkov, vendar trenutno ne spada na področje uporabe standarda ISO/TS 20451:2017.
Sklice na standarde ISO 11238, ISO 11239, ISO 11240 in ISO 11615 ter standarde o sporočanju HL7 (HL7 – referenčni informacijski model (RIM), HL7 V3 – splošni model za izdelke (CPM) in HL7 V3 – strukturirano označevanje izdelkov (SPL)) je mogoče uporabiti za informacije o farmacevtskih izdelkih v kontekstu standarda ISO/TS 20451:2017.

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 20451:2018 - Health informatics - Identification of medicinal products - Implementation guidelines for ISO 11616 data elements and structures for the unique identification and exchange of regulated pharmaceutical product information (ISO/TS 20451:2017)

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SLOVENSKI STANDARD
SIST-TS CEN ISO/TS 20451:2018
01-september-2018
Zdravstvena informatika - Identifikacija medicinskih izdelkov - Smernice za
uporabo ISO 11616 podatkovnih elementov in struktur za enotno identifikacijo in
izmenjavo predpisanih informacij o farmacevtskih izdelkih (ISO/TS 20451:2017)
Health informatics - Identification of medicinal products - Implementation guidelines for
ISO 11616 data elements and structures for the unique identification and exchange of
regulated pharmaceutical product information (ISO/TS 20451:2017)
Medizinische Informatik - Identifikation von Arzneimitteln - Implementierungsleitfaden für
ISO 11616 Datenelemente und -strukturen zur eindeutigen Identifikation und zum
Austausch von Informationen über pharmazeutische Produkte (ISO/TS 20451:2017)
Informatique de santé - Identification des médicaments - Lignes directrices pour
l’implémentation des éléments de données et structures ISO 11616 pour l’identification
unique et l’échange d’informations réglementées sur les produits pharmaceutiques
(ISO/TS 20451:2017)
Ta slovenski standard je istoveten z: CEN ISO/TS 20451:2018
ICS:
35.240.80 Uporabniške rešitve IT v IT applications in health care
zdravstveni tehniki technology
SIST-TS CEN ISO/TS 20451:2018 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 20451:2018

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SIST-TS CEN ISO/TS 20451:2018


CEN ISO/TS 20451
TECHNICAL SPECIFICATION

SPÉCIFICATION TECHNIQUE

May 2018
TECHNISCHE SPEZIFIKATION
ICS 35.240.80
English Version

Health informatics - Identification of medicinal products -
Implementation guidelines for ISO 11616 data elements
and structures for the unique identification and exchange
of regulated pharmaceutical product information (ISO/TS
20451:2017)
Informatique de santé - Identification des médicaments Medizinische Informatik - Identifikation von
- Lignes directrices pour l'implémentation des Arzneimitteln - Implementierungsleitfaden für ISO
éléments de données et structures ISO 11616 pour 11616 Datenelemente und -strukturen zur eindeutigen
l'identification unique et l'échange d'informations Identifikation und zum Austausch von Informationen
réglementées sur les produits pharmaceutiques über pharmazeutische Produkte (ISO/TS 20451:2017)
(ISO/TS 20451:2017)
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 20451:2018 E
worldwide for CEN national Members.

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SIST-TS CEN ISO/TS 20451:2018
CEN ISO/TS 20451:2018 (E)
Contents Page
European foreword . 3
Endorsement notice . 3

2

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SIST-TS CEN ISO/TS 20451:2018
CEN ISO/TS 20451:2018 (E)
European foreword
This document (CEN ISO/TS 20451:2018) 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.
Ac
...

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