SIST-TS CEN ISO/TS 20440:2016

SLOVENSKI STANDARD
SIST-TS CEN ISO/TS 20440:2016
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
SIST-TS CEN ISO/TS 20440:2016 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 20440:2016

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SIST-TS CEN ISO/TS 20440:2016


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.

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CEN ISO/TS 20440:2016 (E)
Contents Page
European foreword . 3

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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.
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SIST-TS CEN ISO/TS 20440:2016
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

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ISO/TS 20440:2016(E)

COPYRIGHT PROTECTED DOCUMENT
© 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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CH-1214 Vernier, Geneva, Switzerland
Tel. +41 22 749 01 11
Fax +41 22 749 09 47
copyright@iso.org
www.iso.org
ii © ISO 2016 – All rights reserved

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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
4.2.1 General.38
4.2.2 Addition of regional terms to the database .38
4.2.3 Mapping regional terms to central coded concepts .41
4.2.4 Versioning of mapped regional terms .41
4.2.5 Mapped regional term example: Extended-release caplet .41
Bibliography .43
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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 on the meaning of ISO specific terms and expressions related to conformity
assessment, as well as information about ISO’s adherence to the WTO principles in the Technical
Barriers to Trade (TBT), see the following URL: Foreword — Supplementary information.
The committee responsible for this document is ISO/TC 215, Health informatics.
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Introduction
The terminologies described in EN/ISO 11239:2012 (hereafter referred to as ISO 11239) and in this
Technical Specification 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 Technical Specification is to describe how
these controlled vocabularies are constructed and illustrate their use for ISO 11239 implementation.
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SIST-TS CEN ISO/TS 20440:2016
TECHNICAL SPECIFICATION ISO/TS 20440:2016(E)
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
1 Scope
This Technical Specification 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.
This Technical Specification 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.
2 Organisation of controlled terms
2.1 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 3
describes the different types of terminologies and sub-vocabularies that use these data types, and any
relevant relationships between them.
Each field in Clause 2 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;
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— “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.
2.2 Code-term pair and coded concept
2.2.1 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.
2.2.2 Code-term pair
2.2.2.1 Code-term pair overview
This is the underlying class for each term, and 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 shall be used.
When a new concept is required, a new coded concept must 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 organisation shall provide
instructions on how to request a new term or a revision to an existing term.
2.2.2.2 Code-term pair: Code
User Guidance This field contains a unique, machine-readable identifier for the code-term pair. In this
Technical Specification, 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.
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The codes used in this Technical Specification 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
2.2.2.3 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.
2.2.2.4 Code-term pair: Definition
User Guidance This field contains the textual definition for the code-term pair. The definition is as com-
prehensive as possible, in order to guide the user to the most appropriate term to describe
a given concept. For example, it should be detailed enough to distinguish between similar
pharmaceutical dose forms, and may exceptionally 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 default 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 definition provided, the definition in the code-term
pair for the default language/region combination is adopted.
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2.2.2.5 Code-term pair: Domain
User Guidance This field is used to identify whether a term is considered appropriate for both human
and veterinary use, or whether it is considered appropriate for veterinary use only.
Data Type Concept Descriptor
Conformance Optional
Value Allowed ”Human and veterinary”; “Veterinary only”
Business Rule(s) Each code-term pair may have one domain. Although veterinary medicines are outside the
scope of IDMP, certain regions use a single terminology system to cover both medicines
for human use and medicines for veterinary use; this optional field is therefore included
in order to allow veterinary-only terms to be easily distinguished in such systems.
2.2.2.6 Code-term pair: Comment
User Guidance This optional field contains a textual comment for the code-term pair. It is used to provide
to the user additional information and guidance that would not be strictly appropriate
to appear as part of the definition.
Data Type String
Conformance Optional
Value Allowed Free text
Business Rule(s) Each code-term pair may have one comment.
2.2.2.7 Code-term pair: Language code
User Guidance This field contains the language in which the term, definition and comment are described;
in this Technical Specification, the working language is English. The language code used
is in line with ISO 639-1.
Data Type Concept Descriptor
Conformance Mandatory
Value Allowed ISO 639-1 code, OID reference 1.0.639.1
Business Rule(s) Each code-term pair shall have one language code.
2.2.2.8 Code-term pair: Region code
User Guidance This field contains the region/country that uses this code-term pair, in the language de-
scribed above; it can be used to differentiate between regional variants of that language;
in this Technical Specification, the default region is the United Kingdom. The region code
used is in line with ISO 3166-1. Alpha-2 (i.e. 2-letter) codes are used. The additional code
EU is also allowed to represent the European Union. It should be noted that the United
Kingdom is represented in ISO 3166-1 by the 2-letter code GB, as in the examples used
in this Technical Specification.
Data Type Concept Descriptor
Conformance Mandatory
Value Allowed ISO 3166-1 alpha-2 code, OID reference 1.0.3166.1.2.2.
Business Rule(s) Each code-term pair shall have one region code.
2.2.2.9 Code-term pair example
An example of a code-term pair for the concept “Tablet”, a pharmaceutical dose form, is shown in
Table 2. Since the working language of this Technical Specification is UK English, the language is English
and the region is the United Kingdom.
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Table 2 — Example code-term pair for pharmaceutical dose form “Tablet” in UK English
Code PDF-10219000-EN-GB
Term Tablet
Solid single-dose uncoated preparation obtained by compressing uniform volumes of par-
ticulate solids or by other means such as extrusion or moulding. Tablets include single-layer
tablets resulting from a single compression of particles a
...