SIST-TS CEN ISO/TS 20440:2023

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 20440:2023)

This document 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 document, 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.
This document is intended for use by:
—    any organization that might be responsible for developing and maintaining such controlled vocabularies;
—    any regional authorities or software vendors who want to use the controlled vocabularies in their own systems and need to understand how they are created;
—    owners of databases who want to map their own terms to a standardized list of controlled vocabularies;
—    other users who want to understand the hierarchy of the controlled vocabularies in order to help identify the most appropriate term to describe a particular concept.
This document does not specify a particular terminology for the implementation of ISO 11239.

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 20440:2023)

Dieses Dokument beschreibt Datenelemente und Strukturen zur eindeutigen Identifizierung und zum Austausch von vorgeschriebenen Informationen über pharmazeutische Darreichungsformen, pharmazeutische Konventionseinheiten, Verabreichungswege und Verpackungen.
Auf der Grundlage der in diesem Dokument dargestellten Grundsätze werden harmonisierte kontrollierte Terminologien nach einem vereinbarten Datenpflegeprozess 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 vorgesehen zur Anwendung durch:
   alle Organisationen, 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 erzeugt werden;
   Datenbankbesitzer, die ihre eigenen Benennungen auf eine genormte Liste von kontrollierten Vokabularien abbilden wollen;
   weitere Nutzer, die die Hierarchie der kontrollierten Vokabularien verstehen wollen, damit sie die zur Beschreibung eines bestimmten Begriffes am besten geeignete Benennung identifizieren können.
Dieses Dokument legt keine bestimmte Terminologie für die Implementierung von ISO 11239 fest.

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 20440:2023)

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 20440:2023)

Ta dokument 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 tem dokumentu, 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 bo nato mogoče uporabiti na ustreznih področjih v PhPID, PCID in MPID za identifikacijo teh konceptov.
Ta dokument je namenjen:
–    vsem organizacijam, ki so morda odgovorne za razvoj in vzdrževanje takšnih nadzorovanih slovarjev;
–    vsem regionalnim organom ali dobaviteljem programske opreme, ki želijo uporabljati nadzorovane slovarje v svojih sistemih in se morajo seznaniti z načinom njihove izdelave;
–    lastnikom zbirk podatkov, ki želijo preslikati lastne izraze v standardizirani seznam nadzorovanih slovarjev;
–    drugim uporabnikom, ki se želijo seznaniti s hierarhijo nadzorovanih slovarjev kot pomoč pri prepoznavanju najustreznejšega izraza za opis določenega koncepta.
Ta dokument ne določa posebne terminologije za izvajanje standarda ISO 11239.

General Information

• Status: Published
• Publication Date: 11-Jun-2023
• ICS: 35.240.80 - IT applications in health care technology
• Technical Committee: ITC - Information technology
• Current Stage: 6060 - National Implementation/Publication (Adopted Project)
• Start Date: 26-May-2023
• Due Date: 31-Jul-2023
• Completion Date: 12-Jun-2023
• Ref Project: 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)

Relations

• Replaces: 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)
• Effective Date: 01-Jul-2023

Standards Content (Sample)

SLOVENSKI STANDARD
SIST-TS CEN ISO/TS 20440:2023
01-julij-2023
Nadomešča:
SIST-TS CEN 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 20440:2023)
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 20440:2023)
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 20440:2023)
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
20440:2023)
Ta slovenski standard je istoveten z: CEN ISO/TS 20440:2023
ICS:
35.240.80 Uporabniške rešitve IT v IT applications in health care
zdravstveni tehniki technology
SIST-TS CEN ISO/TS 20440:2023 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 20440:2023

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SIST-TS CEN ISO/TS 20440:2023


CEN ISO/TS 20440
TECHNICAL SPECIFICATION

SPÉCIFICATION TECHNIQUE

April 2023
TECHNISCHE SPEZIFIKATION
ICS 35.240.80 Supersedes CEN ISO/TS 20440:2016
English Version

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)
Informatique de santé - Identification des produits Medizinische Informatik - Identifikation von
médicaux - Guide de mise en œuvre 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 20440:2023) pharmazeutische Konventionseinheiten,
Verabreichungswegen und Verpackungen (ISO/TS
20440:2023)
This Technical Specification (CEN/TS) was approved by CEN on 10 March 2023 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, 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
© 2023 CEN All rights of exploitation in any form and by any means reserved Ref. No. CEN ISO/TS 20440:2023 E
worldwide for CEN national Members.

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SIST-TS CEN ISO/TS 20440:2023
CEN ISO/TS 20440:2023 (E)
Contents Page
European foreword . 3

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SIST-TS CEN ISO/TS 20440:2023
CEN ISO/TS 20440:2023 (E)
European foreword
This document (CEN ISO/TS 20440:2023) 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.
This document supersedes CEN ISO/TS 20440:2016.
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 announce this Technical Specification: 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/TS 20440:2023 has been approved by CEN as CEN ISO/TS 20440:2023 without any
modification.


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SIST-TS CEN ISO/TS 20440:2023

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SIST-TS CEN ISO/TS 20440:2023
TECHNICAL ISO/TS
SPECIFICATION 20440
Second edition
2023-03
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
Informatique de santé — Identification des produits médicaux —
Guide de mise en œuvre 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 20440:2023(E)
© ISO 2023

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SIST-TS CEN ISO/TS 20440:2023
ISO/TS 20440:2023(E)
COPYRIGHT PROTECTED DOCUMENT
© ISO 2023
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: [phone]
Email: [e-mail]
Website: www.iso.org
Published in Switzerland
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SIST-TS CEN ISO/TS 20440:2023
ISO/TS 20440:2023(E)
Contents Page
Foreword .iv
Introduction .v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Organization of controlled terms . 2
4.1 General . 2
4.2 Code-term pair and coded concept . 2
4.2.1 General . 2
4.2.2 Code-term pair . 2
4.2.3 Coded concept . 5
4.3 Versioning . 7
4.3.1 Versioning of the term . 7
4.3.2 Versioning of the terminology . 10
5 Terminologies .10
5.1 General . 10
5.2 Pharmaceutical dose form . 10
5.2.1 Pharmaceutical dose form overview . 10
5.2.2 Pharmaceutical dose form schema . 11
5.2.3 Pharmaceutical dose form example: Prolonged-release tablet . 17
5.2.4 Using pharmaceutical dose form attributes directly .22
5.3 Combined pharmaceutical dose form . 23
5.3.1 Combined pharmaceutical dose form overview .23
5.3.2 Combined pharmaceutical dose form schema . 24
5.3.3 Combined pharmaceutical dose form example: Powder and solvent for
solution for injection . 25
5.3.4 Other authorised combinations of terms — Combined terms and
combination packs . 26
5.4 Unit of presentation .28
5.4.1 Unit of presentation overview .28
5.4.2 Unit of presentation schema .28
5.4.3 Unit of presentation example: Tablet .29
5.5 Route of administration . 30
5.5.1 Route of administration overview .30
5.5.2 Route of administration schema .30
5.5.3 Route of administration example: Intravenous use . 31
5.6 Packaging . 31
5.6.1 Packaging overview . 31
5.6.2 Packaging schema . 31
5.6.3 Packaging example: Ampoule (Packaging category: Container) .33
5.6.4 Packaging example: Screw cap (Packaging category: Closure) .34
5.6.5 Packaging example: Oral syringe (Packaging category: Administration
device) . 36
5.6.6 Packaging concept summaries. 37
6 Mapping of regional terms .38
6.1 Differences in granularity between regional terminologies .38
6.2 Organization of regional terms in the database .40
6.2.1 General .40
6.2.2 Addition of regional terms to the database .40
6.2.3 Mapping regional terms to standardized coded concepts . 43
6.2.4 Versioning of mapped regional terms . 43
6.2.5 Mapped regional term example: Extended-release caplet .44
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SIST-TS CEN ISO/TS 20440:2023
ISO/TS 20440:2023(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
patent rights. ISO shall not be held responsible for identifying any or all such patent rights. Details of
any patent rights identified during the development of the document will be in the Introduction and/or
on the ISO list of patent declarations received (see www.iso.org/patents).
Any trade name used in this document is information given for the convenience of users and does not
constitute an endorsement.
For an explanation of the voluntary nature of standards, the meaning of ISO specific terms and
expressions related to conformity assessment, as well as information about ISO's adherence to
the World Trade Organization (WTO) principles in the Technical Barriers to Trade (TBT), see
www.iso.org/iso/foreword.html.
This document was prepared by Technical Committee ISO/TC 215, Health informatics, in collaboration
with the European Committee for Standardization (CEN) Technical Committee CEN/TC 251, Health
informatics, in accordance with the Agreement on technical cooperation between ISO and CEN (Vienna
Agreement).
This second edition cancels and replaces the first edition (ISO/TS 20440:2016), which has been
technically revised.
The main changes are as follows:
— addition of a recommendation to label administrable dose forms as such, to distinguish them from
those pharmaceutical dose forms that are only manufactured dose forms;
— a section has been added describing how pharmaceutical dose form attributes can be used directly,
rather than simply serving to classify the pharmaceutical dose form;
— several examples have been updated to reflect terms and definitions that are in use.
Any feedback or questions on this document should be directed to the user’s national standards body. A
complete listing of these bodies can be found at http://www.iso.org/members.html.
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SIST-TS CEN ISO/TS 20440:2023
ISO/TS 20440:2023(E)
Introduction
The terminologies described in ISO 11239 and in this document are essential for the implementation of
the IDMP standards as a whole.
Each region traditionally uses its own sets of terminologies to describe the concepts covered in
ISO 11239 within their regions; these terminologies are not harmonised with those of the other regions.
Therefore, harmonised controlled terminologies need to be provided to ensure that all regions can
refer to a given concept in the same manner. The purpose of this document is to describe how these
controlled vocabularies are constructed and illustrate their use for ISO 11239 implementation.
A number of the codes, terms and definitions used as examples in this document are taken from the
Standard Terms database of the European Directorate for the Quality of Medicines & HealthCare,
Council of Europe (EDQM), specifically those for UK English (EN-GB). The EDQM Standard Terms
database is not static and its content changes over time, so the examples provided in this document
might not remain current; furthermore, examples provided in language/region combinations other
than UK English are not necessarily taken from the EDQM Standard Terms database.
The EDQM Standard Terms database is an example of an implementation of ISO 11239, but reference to it
in this document does not imply that it is the standardized terminology to use for IDMP implementation.
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SIST-TS CEN ISO/TS 20440:2023

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SIST-TS CEN ISO/TS 20440:2023
TECHNICAL SPECIFICATION ISO/TS 20440:2023(E)
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
1 Scope
This document 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 document, 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.
This document is intended for use by:
— any organization that might be responsible for developing and maintaining such controlled
vocabularies;
— any regional authorities or software vendors who want to use the controlled vocabularies in their
own systems and need to understand how they are created;
— owners of databases who want to map their own terms to a standardized list of controlled
vocabularies;
— other users who want to understand the hierarchy of the controlled vocabularies in order to help
identify the most appropriate term to describe a particular concept.
This document does not specify a particular terminology for the implementation of ISO 11239.
2 Normative references
The following documents are referred to in the text in such a way that some or all of their content
constitutes requirements of this document. For dated references, only the edition cited applies. For
undated references, the latest edition of the referenced document (including any amendments) applies.
ISO 11239, Health informatics — Identification of medicinal products — 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
3 Terms and definitions
No terms and definitions are listed in this document.
1
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SIST-TS CEN ISO/TS 20440:2023
ISO/TS 20440:2023(E)
ISO and IEC maintain terminology databases for use in standardization at the following addresses:
— ISO Online browsing platform: available at https:// www .iso .org/ obp
— IEC Electropedia: available at https:// www .electropedia .org/
4 Organization of controlled terms
4.1 General
This clause describes how each controlled term is built, describing the data types used to convey
the information and the versioning requirements for tracking their creation and evolution. Clause 5
describes the different types of terminologies and sub-vocabularies that use these data types, and any
relevant relationships between them.
Each field in Clause 4 is described under a separate subclause, consisting of the title of the field and a
table containing the following:
— "User Guidance", a description of the field;
— "Data Type", a description of the data type;
— "Conformance", a description of whether the field is mandatory, optional, or conditional;
— "Value Allowed", indicating the possible values for the field;
— "Business Rules", providing technical guidance for the field.
4.2 Code-term pair and coded concept
4.2.1 General
The code-term pair and the coded concept are the data types that are used to represent the information
that is required to describe each term in each terminology or sub-vocabulary, in each language/region
combination.
4.2.2 Code-term pair
4.2.2.1 Code-term pair overview
This is the underlying class for each term, and it is used to describe and define a term in a specific
language and for a specific region. It contains the core attributes for each concept, including the
identifier, the textual representation of the term (i.e. the controlled term itself), the definition, an
optional domain to indicate whether a term is restricted to veterinary use, an optional textual comment,
and the language and region codes.
Each controlled term or sub-term has a unique code-term pair for each language/region combination.
This combination of language and region allows for regional variants of a specific language to be catered
for; for example, where the spelling of a term or definition differs between UK English and US English, it
is possible to reflect this difference. Where terms and definitions already exist for a particular language
for a particular region, and the same language is used in a second region, it is a regional implementation
issue to decide whether terms and definitions need to be provided for the second region, or whether the
terms and definitions of the first region must be used.
When a new concept is required, a new coded concept shall be created, and at least one code-term pair
is required in order to hold the data to describe the concept. The language/region combination chosen
to represent the "value" shall always be created first to represent the concept, even when the request
originates from a different language/region combination. The maintenance organization shall provide
instructions on how to request a new term or a revision to an existing term.
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SIST-TS CEN ISO/TS 20440:2023
ISO/TS 20440:2023(E)
4.2.2.2 Code-term pair: Code
User Guidance This field contains a unique, machine-readable identifier for the code-term pair.
In this document, the following format is used for the code:
— XXX-12345678-LL-RR
where
— XXX represents the class of term (see Table 1);
— 12345678 represents a unique 8-digit number; for sub-vocabularies, a
4-digit number is used;
— LL represents the language code;
— RR represents the region/country code.
Data Type String
Conformance Mandatory
Value Allowed Free text
Business Rule(s) Each code-term pair shall have one code.
The codes used in this document to represent the various classes of term in the examples that follow
are shown in Table 1.
Table 1 — Codes used to represent the class of term
Code Class
SOM State of matter
BDF Basic dose form
RCA Release characteristics
TRA Transformation
ISI Intended site
AME Administration method
PDF Pharmaceutical dose form
CDF Combined pharmaceutical dose form
UOP Unit of presentation
ROA Route of administration
PCA Packaging category
CON Container
CLO Closure
DEV Administration device
MAP Mapped term
4.2.2.3 Code-term pair: Term
User Guidance This field contains the textual term description for the code-term pair.
Data Type String
Conformance Mandatory
Value Allowed Free text
Business Rule(s) Each code-term pair shall have one term.
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SIST-TS CEN ISO/TS 20440:2023
ISO/TS 20440:2023(E)
4.2.2.4 Code-term pair: Definition
User Guidance This field contains the textual definition for the code-term pair. The definition
is as comprehensive as possible, in order to guide the user to the most appropri-
ate term to describe a given concept. For example, it should be detailed enough
to distinguish between similar pharmaceutical dose forms, and may exception-
ally make direct reference to related terms in order to exclude them, although
such references may be considered more appropriate in the Comments section
instead.
Data Type String
Conformance Mandatory for the default code-term pair; optional for the translation code-
term pairs
Value Allowed Free text
Business Rule(s) Each code-term pair may have one definition. For each coded concept, the de-
fault code-term pair (e.g. EN-GB) shall have one definition. If a code-term pair
for a given language/region combination does not have a defi
...