CEN ISO/TS 20440:2016

Health informatics - Identification of medicinal products - Implementation guide for ISO 11239 data elements and structures for the unique identification and exchange of regulated information on pharmaceutical dose forms, units of presentation, routes of administration and packaging (ISO/TS 20440:2016)

ISO/TS 20440:2016 describes data elements and structures for the unique identification and exchange of regulated information on pharmaceutical dose forms, units of presentation, routes of administration and packaging.
Based on the principles outlined in this Technical Specification, harmonised controlled terminologies will be developed according to an agreed maintenance process, allowing users to consult the terminologies and locate the appropriate terms for the concepts that they wish to describe. Provisions to allow for the mapping of existing regional terminologies to the harmonised controlled terminologies will also be developed in order to facilitate the identification of the appropriate terms. The codes provided for the terms can then be used in the relevant fields in the PhPID, PCID and MPID in order to identify those concepts.
ISO/TS 20440:2016 is intended for use by:
-      any organisation that might be responsible for developing and maintaining such controlled vocabularies;
-      any regional authorities or software vendors who wish to use the controlled vocabularies in their own systems and need to understand how they are created;
-      owners of databases who wish to map their own terms to a central list of controlled vocabularies;
-      other users who wish to understand the hierarchy of the controlled vocabularies in order to help identify the most appropriate term to describe a particular concept.
The terminology to be applied in the context of this Technical Specification and set out in ISO 11239 is under development. All codes, terms and definitions used as examples in this Technical Specification are provided for illustration purposes only, and are not intended to represent the final terminology.

Medizinische Informatik - Identifikation von Arzneimitteln - Implementierungsleitfaden für ISO 11239 Datenelemente und Strukturen zur eindeutigen Identifikation und zum Austausch von vorgeschriebenen Informationen über pharmazeutische Darreichungsformen, pharmazeutische Konventionseinheiten, Verabreichungswegen und Verpackungen (ISO/TS 20440:2016)

Dieses Dokument beschreibt Datenelemente und Strukturen zur eindeutigen Identifizierung und zum Austausch von vorgeschriebenen Informationen über pharmazeutische Darreichungsformen, pharmazeutische Konventionseinheiten, Anwendungsarten und Verpackungen.
Auf der Grundlage der in diesem Dokument dargestellten Grundsätze werden harmonisierte kontrollierte Terminologien nach einem vereinbarten Pflegeprozess entwickelt, wodurch es den Nutzern ermöglicht wird, die Terminologien heranzuziehen und die geeigneten Benennungen für die Begriffe zu finden, die sie beschreiben möchten. Außerdem werden auch Maßnahmen entwickelt, die eine Abbildung der vorhandenen regionalen Terminologien gegenüber den harmonisierten kontrollierten Terminologien ermöglichen, damit die Identifizierung der entsprechenden Benennungen erleichtert wird. Die für die Benennungen bereitgestellten Codes können dann in den entsprechenden Feldern im PhPID (Identifikator eines pharmazeutischen Produkts), PCID (verpackungsbezogener Arzneimittel-Identifikator) und MPID (Arzneimittel-Identifikator) angewendet werden, um diese Begriffe zu identifizieren.
Das vorliegende Dokument ist zur Anwendung durch
—   alle Organisationen vorgesehen, die für die Entwicklung und Pflege derartiger kontrollierter Vokabularien verantwortlich sein könnten,
—   alle regionalen Behörden oder Softwareanbieter, die die kontrollierten Vokabularien in ihren eigenen Systemen anwenden wollen und verstehen müssen, wie sie erstellt werden,
—   Datenbankbesitzer, die ihre eigenen Benennungen auf eine zentrale Liste von kontrollierten Vokabularien abbilden wollen,
—   weitere Nutzer, die die Hierarchie der kontrollierten Vokabularien verstehen möchten, damit sie die zur Beschreibung eines bestimmten Begriffes am besten geeignete Benennung identifizieren können.
Die im Zusammenhang mit diesem Dokument anzuwendende und in ISO 11239 aufgeführte Terminologie befindet sich noch in der Entwicklungsphase. Alle Codes, Benennungen und Definitionen, die in diesem Dokument als Beispiele angewendet werden, sind lediglich zum Zwecke der Veranschaulichung bereitgestellt worden und sollen nicht die endgültige Terminologie darstellen.

Informatique de santé - Identification des produits médicaux - Guide de mise en oeuvre des éléments de données et structures pour l'identification unique et l'échange d'informations réglementées sur les formes des doses pharmaceutiques, les unités de présentation, les voies d'administration et les emballages de l'ISO 11239 (ISO/TS 20440:2016)

Zdravstvena informatika - Identifikacija medicinskih izdelkov - Vodilo za uporabo ISO 11239 podatkovnih elementov in struktur za enotno identifikacijo in izmenjavo predpisanih informacij o farmacevtskih odmerkih, predstavitvenih enotah, administrativnih poteh in pakiranju (ISO/TS 20440:2016)

Ta tehnična specifikacija navaja podatkovne elemente in strukture za enotno identifikacijo in izmenjavo predpisanih informacij o farmacevtskih odmerkih, predstavitvenih enotah, administrativnih poteh in pakiranju.
Na podlagi načel, navedenih v tej tehnični specifikaciji, bo razvita usklajena nadzorovana terminologija v skladu z dogovorjenim procesom vzdrževanja, kar bo uporabnikom omogočalo vpogled v terminologijo in odkrivanje ustreznih izrazov za koncepte, ki jih želijo opisati. Razvita bodo tudi določila, ki bodo omogočala preslikavo obstoječe regionalne terminologije v usklajeno nadzorovano terminologijo za lažjo identifikacijo ustreznih izrazov. Kode za izraze se bodo nato lahko uporabljale na ustreznih področjih v PhPID, PCID in MPID za identifikacijo teh konceptov.
Ta tehnična specifikacija je namenjena:
– vsem organizacijam, ki so morda odgovorne za razvijanje in vzdrževanje takšnih nadzorovanih slovarjev;
– vsem regionalnim organom ali dobaviteljem programske opreme, ki želijo uporabljati nadzorovane slovarje v svojih sistemih in se morajo seznaniti, na kakšen način se ustvarjajo;
– lastnikom zbirk podatkov, ki želijo preslikati lastne izraze v centralni seznam nadzorovanih slovarjev;
– drugim uporabnikom, ki se želijo seznaniti s hierarhijo nadzorovanih slovarjev kot pomoč pri prepoznavanju najustreznejšega izraza za opis določenega koncepta.
Terminologija, ki se uporablja v kontekstu te tehnične specifikacije in je določena v standardu ISO 11239, je v pripravi. Vse kode, izrazi in definicije, uporabljene kot primeri v tej tehnični specifikaciji, so podane samo za namene ponazoritve in ne predstavljajo končne terminologije.

General Information

• Status: Withdrawn
• Publication Date: 28-Jun-2016
• Withdrawal Date: 11-Apr-2023
• 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
• Ref Project: SIST-TS CEN ISO/TS 20440:2016 - Health informatics - Identification of medicinal products - Implementation guide for ISO 11239 data elements and structures for the unique identification and exchange of regulated information on pharmaceutical dose forms, units of presentation, routes of administration and packaging (ISO/TS 20440:2016)

Relations

• Replaced By: CEN ISO/TS 20440:2023 - Health informatics - Identification of medicinal products - Implementation guidelines for ISO 11239 data elements and structures for the unique identification and exchange of regulated information on pharmaceutical dose forms, units of presentation, routes of administration and packaging (ISO/TS 20440:2023)
• Effective Date: 19-Jan-2023

Standards Content (Sample)

SLOVENSKI STANDARD
01-december-2016
Zdravstvena informatika - Identifikacija medicinskih izdelkov - Vodilo za uporabo
ISO 11239 podatkovnih elementov in struktur za enotno identifikacijo in izmenjavo
predpisanih informacij o farmacevtskih odmerkih, predstavitvenih enotah,
administrativnih poteh in pakiranju (ISO/TS 20440:2016)
Health informatics - Identification of medicinal products - Implementation guide for ISO
11239 data elements and structures for the unique identification and exchange of
regulated information on pharmaceutical dose forms, units of presentation, routes of
administration and packaging (ISO/TS 20440:2016)
Medizinische Informatik - Identifikation von Arzneimitteln - Anwendungsleitfaden für ISO
11239 Struktur und kontrollierte Vokabularien zur Identifikation von pharmazeutischen
Darreichungsformen, pharmazeutischen Konventionseinheiten, Anwendungsarten und
Verpackungen (ISO/TS 20440:2016)
Informatique de santé - Identification des produits médicaux - Guide de mise en oeuvre
des éléments de données et structures pour l'identification unique et l'échange
d'informations réglementées sur les formes des doses pharmaceutiques, les unités de
présentation, les voies d'administration et les emballages de l'ISO 11239 (ISO/TS
20440:2016)
Ta slovenski standard je istoveten z: CEN ISO/TS 20440:2016
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.

CEN ISO/TS 20440
TECHNICAL SPECIFICATION
SPÉCIFICATION TECHNIQUE
June 2016
TECHNISCHE SPEZIFIKATION
ICS 35.240.80
English Version
Health informatics - Identification of medicinal products -
Implementation guide for ISO 11239 data elements and
structures for the unique identification and exchange of
regulated information on pharmaceutical dose forms, units
of presentation, routes of administration and packaging
(ISO/TS 20440:2016)
Informatique de santé - Identification des produits Medizinische Informatik - Identifikation von
médicaux - Guide de mise en oeuvre des éléments de Arzneimitteln - Implementierungsleitfaden für ISO
données et structures pour l'identification unique et 11239 Datenelemente und Strukturen zur eindeutigen
l'échange d'informations réglementées sur les formes Identifikation und zum Austausch von
des doses pharmaceutiques, les unités de présentation, vorgeschriebenen Informationen über
les voies d'administration et les emballages de l'ISO pharmazeutische Darreichungsformen,
11239 (ISO/TS 20440:2016) pharmazeutische Konventionseinheiten,
Anwendungsarten und Verpackungen (ISO/TS
20440:2016)
This Technical Specification (CEN/TS) was approved by CEN on 29 May 2016 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, 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: Avenue Marnix 17, B-1000 Brussels
© 2016 CEN All rights of exploitation in any form and by any means reserved Ref. No. CEN ISO/TS 20440:2016 E
worldwide for CEN national Members.

Contents Page
European foreword . 3

European foreword
This document (CEN ISO/TS 20440:2016) 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 [and/or CENELEC] 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
following countries are bound to announce this Technical Specification: 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, Slovakia, Slovenia, Spain, Sweden, Switzerland,
Turkey and the United Kingdom.
Endorsement notice
The text of ISO/TS 20440:2016 has been approved by CEN as CEN ISO/TS 20440:2016 without any
modification.
TECHNICAL ISO/TS
SPECIFICATION 20440
First edition
2016-06-01
Health informatics — Identification
of medicinal products —
Implementation guide for ISO
11239 data elements and structures
for the unique identification and
exchange of regulated information on
pharmaceutical dose forms, units of
presentation, routes of administration
and packaging
Informatique de santé — Identification des produits médicaux —
Guide de mise en oeuvre des éléments de données et structures pour
l’identification unique et l’échange d’informations réglementées sur
les formes des doses pharmaceutiques, les unités de présentation, les
voies d’administration et les emballages de l’ISO 11239
Reference number
ISO/TS 20440:2016(E)
©
ISO 2016
ISO/TS 20440:2016(E)
© ISO 2016, Published in Switzerland
All rights reserved. Unless otherwise specified, 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
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Tel. [phone]
Fax [phone]
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ii © ISO 2016 – All rights reserved

ISO/TS 20440:2016(E)
Contents Page
Foreword .iv
Introduction .v
1 Scope . 1
2 Organisation of controlled terms . 1
2.1 General . 1
2.2 Code-term pair and coded concept . 2
2.2.1 General. 2
2.2.2 Code-term pair. 2
2.2.3 Coded concept . 5
2.3 Versioning. 6
2.3.1 Versioning of the term . . 6
2.3.2 Versioning of the terminology . 9
3 Terminologies . 9
3.1 General . 9
3.2 Pharmaceutical dose form .10
3.2.1 Pharmaceutical dose form overview .10
3.2.2 Pharmaceutical dose form schema .10
3.2.3 Pharmaceutical dose form example: Prolonged-release tablet .16
3.3 Combined pharmaceutical form .21
3.3.1 Combined pharmaceutical dose form overview .21
3.3.2 Combined pharmaceutical dose form schema .22
3.3.3 Combined pharmaceutical dose form example: Powder and solvent for
solution for injection .23
3.3.4 Other authorised combinations of terms — Combined terms and
combination packs .25
3.4 Unit of presentation .26
3.4.1 Unit of presentation overview .26
3.4.2 Unit of presentation schema .27
3.4.3 Unit of presentation example: Tablet .27
3.5 Route of administration .28
3.5.1 Route of administration overview .28
3.5.2 Route of administration schema .29
3.5.3 Route of administration example: Intravenous use .29
3.6 Packaging .30
3.6.1 Packaging overview .30
3.6.2 Packaging schema .30
3.6.3 Packaging example: Ampoule (Packaging category: Container) .31
3.6.4 Packaging example: Screw cap (Packaging category: Closure) .33
3.6.5 Packaging example: Oral syringe (Packaging category: Administration device) .34
3.6.6 Packaging concept summaries .36
4 Mapping of regional terms .36
4.1 Differences in granularity between regional terminologies .36
4.2 Organisation of regional terms in the database .38
...