SIST EN ISO 11240:2013

SLOVENSKI STANDARD
SIST EN ISO 11240:2013
01-februar-2013
Zdravstvena informatika - Identifikacija medicinskih izdelkov - Elementi in zgradba
podatkov za enotno identifikacijo in izmenjavo merilnih enot (ISO 11240:2012)
Health informatics - Identification of medicinal products - Data elements and structures
for the unique identification and exchange of units of measurement (ISO 11240:2012)
Medizinische Informatik - Identifikation von Arzneimitteln - Datenelemente, Struktur und
kontrolliertes Vokabular für Maßeinheiten (ISO 11240:2012)
Informatique de santé - Identification des médicaments - Éléments de données et
structures pour l'identification unique et l'échange d'informations sur les unités de
mesure (ISO 11240:2012)
Ta slovenski standard je istoveten z: EN ISO 11240:2012
ICS:
11.020 0HGLFLQVNHYHGHLQ Medical sciences and health
]GUDYVWYHQRYDUVWYHQL care facilities in general
SULSRPRþNLQDVSORãQR
35.240.80 Uporabniške rešitve IT v IT applications in health care
zdravstveni tehniki technology
SIST EN ISO 11240:2013 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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SIST EN ISO 11240:2013

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SIST EN ISO 11240:2013


EUROPEAN STANDARD
EN ISO 11240

NORME EUROPÉENNE

EUROPÄISCHE NORM
November 2012
ICS 35.240.80
English Version
Health informatics - Identification of medicinal products - Data
elements and structures for the unique identification and
exchange of units of measurement (ISO 11240:2012)
Informatique de santé - Identification des médicaments - Medizinische Informatik - Identifikation von Arzneimitteln -
Éléments de données et structures pour l'identification Datenelemente, Struktur und kontrolliertes Vokabular für
unique et l'échange d'informations sur les unités de mesure Maßeinheiten (ISO 11240:2012)
(ISO 11240:2012)
This European Standard was approved by CEN on 24 May 2012.

CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this European
Standard the status of a national standard without any alteration. Up-to-date lists and bibliographical references concerning such national
standards may be obtained on application to the CEN-CENELEC Management Centre or to any CEN member.

This European Standard exists in three official versions (English, French, German). A version in any other language made by translation
under the responsibility of a CEN member into its own language and notified to the CEN-CENELEC Management Centre has the same
status as the official versions.

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

Management Centre: Avenue Marnix 17, B-1000 Brussels
© 2012 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 11240:2012: E
worldwide for CEN national Members.

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SIST EN ISO 11240:2013
EN ISO 11240:2012 (E)
Contents Page
Foreword .3

2

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SIST EN ISO 11240:2013
EN ISO 11240:2012 (E)
Foreword
This document (EN ISO 11240:2012) 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.
This European Standard shall be given the status of a national standard, either by publication of an identical
text or by endorsement, at the latest by May 2013, and conflicting national standards shall be withdrawn at the
latest by May 2013.
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 organisations of the following
countries are bound to implement this European Standard: 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 11240:2012 has been approved by CEN as a EN ISO 11240:2012 without any modification.

3

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SIST EN ISO 11240:2013

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SIST EN ISO 11240:2013
INTERNATIONAL ISO
STANDARD 11240
First edition
2012-11-01
Health informatics — Identification of
medicinal products — Data elements and
structures for the unique identification
and exchange of units of measurement
Informatique de santé — Identification des médicaments — Éléments
de données et structures pour l’identification unique et l’échange
d’informations sur les unités de mesure
Reference number
ISO 11240:2012(E)
©
ISO 2012

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SIST EN ISO 11240:2013
ISO 11240:2012(E)
COPYRIGHT PROTECTED DOCUMENT
© ISO 2012
All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized in any form or by any means,
electronic or mechanical, including photocopying and microfilm, without permission in writing from either ISO at the address below or ISO’s
member body in the country of the requester.
ISO copyright office
Case postale 56 • CH-1211 Geneva 20
Tel. + 41 22 749 01 11
Fax + 41 22 749 09 47
E-mail copyright@iso.org
Web www.iso.org
Published in Switzerland
ii © ISO 2012 – All rights reserved

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SIST EN ISO 11240:2013
ISO 11240:2012(E)
Contents Page
Foreword .iv
Introduction . v
1 Scope . 1
2 Normative references . 1
3 Terms, definitions and abbreviated terms . 1
3.1 Terms and definitions . 1
3.2 Abbreviations . 7
4 Structures and vocabularies . 8
4.1 Overview . 8
4.2 Metrological concepts . 8
4.3 Semantics of units of measurement . 11
4.4 Vocabulary for units of measurement .12
4.5 Domain model .14
4.6 Data elements and technical data model .16
4.7 Operational attributes .25
Annex A (informative) Using units of measurement for expression of medicinal product strength .27
Annex B (informative) Examples to describe data elements .28
Annex C (informative) Example — Controlled terminology mapping .32
Annex D (informative) Domain analysis model .37
Bibliography .45
© ISO 2012 – All rights reserved iii

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SIST EN ISO 11240:2013
ISO 11240:2012(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.
International Standards are drafted in accordance with the rules given in the ISO/IEC Directives, Part 2.
The main task of technical committees is to prepare International Standards. Draft International Standards
adopted by the technical committees are circulated to the member bodies for voting. Publication as an
International Standard requires approval by at least 75 % of the member bodies casting a vote.
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.
ISO 11240 was prepared by Technical Committee ISO/TC 215, Health informatics.
iv © ISO 2012 – All rights reserved

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SIST EN ISO 11240:2013
ISO 11240:2012(E)
Introduction
This International Standard was developed in response to a worldwide demand for internationally harmonized
specifications for medicinal products. It is one of five standards which together provide the basis for the unique
identification of medicinal products. The group of standards comprises:
ISO 11615, Health informatics — Identification of medicinal products — Data elements and structures for the
unique identification and exchange of regulated medicinal product information;
ISO 11616, Health informatics — Identification of medicinal products — Data elements and structures for the
unique identification and exchange of regulated pharmaceutical product information;
ISO 11238, Health informatics — Identification of medicinal products — Data elements and structures for the
unique identification and exchange of regulated information on substances;
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;
ISO 11240, Health informatics — Identification of medicinal products — Data elements and structures for the
unique identification and exchange of units of measurement.
These standards for the Identification of Medicinal Products (IDMP) support the activities of medicines
regulatory agencies worldwide by jurisdiction. These include a variety of regulatory activities related to
development, registration and life cycle management of medicinal products, as well as pharmacovigilance and
risk management.
To meet the primary objectives of the regulation of medicines and pharmacovigilance, it is necessary to reliably
exchange medicinal product information in a robust and reliable manner. The IDMP standards therefore support
the following interactions (this is not an exhaustive list):
— regulator to regulator;
— pharmaceutical company to regulator;
— sponsor of clinical trial to regulator;
— regulator to other stakeholder;
— regulator to worldwide-maintained data sources.
The necessary messaging specifications are included as an integral part of the IDMP standards to secure the
interactions above.
Unique identifiers produced in conformance with the IDMP standards are aimed to support applications where
it is necessary to reliably identify and trace the use of medicinal products.
There are many terms in use to describe basic concepts in the regulatory, pharmaceutical and healthcare
standards development domain for different purposes and in different contexts. The terms and definitions
given in this International Standard are to be applied for the concepts which are required to uniquely identify,
characterize and exchange regulated medicinal products and associated information.
The terms and definitions adopted in this International Standard are intended to facilitate the interpretation and
application of legal and regulatory requirements but they are without prejudice to any legally binding document.
In case of doubt or potential conflict, the terms and definitions contained in legally binding documents prevail.
In the context of measurement terminology, currently there are several alternative approaches possible for
expressing units of measurement that can be used in a given instance. For purposes of electronic data exchange,
it is therefore necessary to promote and encourage the adoption of a single standardized vocabulary that can
be used as an international reference for:
— unit concepts,
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SIST EN ISO 11240:2013
ISO 11240:2012(E)
— concept definitions, where applicable, and
— concept identifiers.
This standardized vocabulary also needs to provide standardized structures that describe the mapping from
and to the reference vocabulary, taking into consideration the various approaches currently being applied.
This helps to ensure that terms and identifiers currently used to represent units of measurement in the drug
regulatory, pharmacovigilance and healthcare environments are mapped in a standardized and traceable way
to the underlying metrological concepts, especially to the SI system of units. This will help ease implementation
of this International Standard without impacting on the unit terms currently in use.
The purpose of this International Standard is twofold:
a) to address the issues outlined above by connecting to existing unit vocabularies in current use;
b) to facilitate electronic information exchange and interoperability that enables the unique and categorical
identification of a medicinal product.
Results of measurements are essential for the identification of medicinal products. However, often different
ways are used to express these results. The situation is further complicated by differences in the ways they
are expressed in national legislation and in local administration. From the many available conventions, a
consensus should therefore be reached on how to express the results of measurements on medicinal products,
particularly for exchange between information systems. Standardized structures are required in order to capture
and exchange the terms representing the coded concepts for purposes of displaying and printing the concept
representations in various languages suitable for human readability.
Universal principles for the expression of measurements have been specified in the ISO 31, ISO 1000 and
ISO 80000 series of standards, which implement the International System of Units (SI) defined by the General
Conference on Weights and Measures. The implications of those standards are summarized in 4.2.
Implementation of this International Standard will provide wider comprehension and interaction between
countries and specialists in the field of medicinal product identification and pharmacovigilance.
While the immediate scope is medicinal product identification, this International Standard was designed with
a rather general view on units of measurement. Therefore, it is also potentially applicable in other contexts.
vi © ISO 2012 – All rights reserved

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SIST EN ISO 11240:2013
INTERNATIONAL STANDARD ISO 11240:2012(E)
Health informatics — Identification of medicinal products —
Data elements and structures for unique identification and
exchange of units of measurement
1 Scope
This International Standard:
— specifies rules for the usage and coded representation of units of measurement for the purpose of exchanging
information about quantitative medicinal product characteristics that require units of measurement (e.g.
strength) in the human medicine domain;
— establishes requirements for units in order to provide traceability to international metrological standards;
— provides rules for the standardized and machine-readable documentation of quantitative composition and
strength of medicinal products, specifically in the context of medicinal product identification;
— defines the requirements for the representation of units of measurement in coded form;
— provides structures and rules for mapping between different unit vocabularies and language translations
to support the implementation of this International Standard, taking into account that existing systems,
dictionaries and repositories use a variety of terms and codes for the representation of units.
The scope of this International Standard is limited to the representation of units of measurement for data
interchange between computer applications.
2 Normative references
The following referenced documents are indispensable for the application 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 639 (all parts), Codes for the representation of names of languages
ISO 3166 (all parts), Codes for the representation of names of countries and their subdivisions
ISO 11238, Health informatics — Identification of medicinal products — Data elements and structures for the
unique identification and exchange of regulated information on substances
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
ISO 21090, Health informatics — Harmonized data types for information interchange
ISO/IEC Guide 99, International vocabulary of metrology — Basic and general concepts and associated terms (VIM)
3 Terms, definitions and abbreviated terms
3.1 Terms and definitions
For the purposes of this document, the following terms and definitions apply.
© ISO 2012 – All rights reserved 1

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SIST EN ISO 11240:2013
ISO 11240:2012(E)
3.1.1
arbitrary unit
arbitrarily defined unit of measurement, where a relation of the unit to a physical unit of the SI does not exist
or is unknown
NOTE Arbitrary units represent references to materials or procedures that are defined outside the SI system. A
quantity value is arbitrarily assigned to the reference preparation or the result of a measurement procedure, usually
specific for a particular substance. This generally precludes comparability of quantity values across different systems and
components for this type of units.
3.1.2
base quantity
quantity in a conventionally chosen subset of a given system of quantities, where no subset quantity can be
expressed in terms of the others
NOTE 1 A base quantity is used to define a base unit (e.g. Length, Time, Temperature).
NOTE 2 Adapted from ISO/IEC Guide 99.
3.1.3
base unit
measurement unit that is adopted by convention for a base quantity
NOTE 1 A set of base units defines a system of units.
EXAMPLE In the SI, the metre is the base unit of length.
NOTE 2 Adapted from ISO/IEC Guide 99.
3.1.4
coherent derived unit
derived unit that, for a given system of quantities and for a chosen set of base units, is a product of powers of
base units with no other proportionality factor than one
NOTE Adapted from ISO/IEC Guide 99.
3.1.5
controlled vocabulary
controlled terminology
finite set of values that represent the only allowed values for a data item
NOTE 1 The allowed values can be codes, text, or numeric.
NOTE 2 Adapted from CDISC Clinical Research Glossary V8.0, 2009.
3.1.6
conversion factor between units
ratio of two measurement units for quantities of the same kind
NOTE Adapted from ISO/IEC Guide 99.
3.1.7
derived quantity
quantity, in a system of quantities, defined in terms of the base quantities of that system
NOTE Adapted from ISO/IEC Guide 99.
3.1.8
derived unit
measurement unit for a derived quantity
NOTE Adapted from ISO/IEC Guide 99.
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SIST EN ISO 11240:2013
ISO 11240:2012(E)
3.1.9
dimension of a quantity
quantity dimension
expression of the dependence of a quantity on the base quantities of a system of quantities as a product of
powers of factors corresponding to the base quantities, omitting any numerical factor
NOTE Adapted from ISO/IEC Guide 99.
3.1.10
dimensionless quantity
quantity of dimension one
quantity for which all the exponents of the factors corresponding to the base quantities in its quantity
dimension are zero
NOTE 1 The term “dimensionless quantity” is commonly used and is kept here for historical reasons. It stems from the
fact that all exponents are zero in the symbolic representation of the dimension for such quantities. The term “quantity of
dimension one” reflects the convention in which the symbolic representation of the dimension for such quantities is the
symbol 1 (see ISO 31-0:1992, 2.2.6).
NOTE 2 Some quantities of dimension one are defined as the ratios of two quantities of the same kind.
EXAMPLE 1 Plane angle, solid angle, refractive index, relative permeability, mass fraction, friction factor, Mach number.
NOTE 3 Numbers of entities are quantities of dimension one.
EXAMPLE 2 Number of turns in a coil, number of cells in a given sample, degeneracy of the energy levels of a
quantum system.
NOTE 4 Adapted from ISO/IEC Guide 99.
3.1.11
kind-of-property
common defining aspect of mutually comparable properties
EXAMPLE Colour, mass, amount-of-substance concentration.
NOTE 1 The hyphens are used to clarify that the modifier “kind” should be seen as part of a connected whole.
NOTE 2 A kind-of-property may be related to nominal scale (e.g. green, blue), ordinal scale (e.g. small, large), differential
scale [e.g. 10 °C (i.e. 10 °C more than an arbitrary zero)], or rational scale (length 2 or 5 m); the last two types are related
to kind-of-quantity.
3.1.12
kind-of-quantity
aspect common to mutually comparable quantities
NOTE 1 The hyphens are used to clarify that the modifier “kind” should be seen as part of a connected whole.
NOTE 2 This concept is necessary for the definition of a measurable quantity, along with a system and often a component.
NOTE 3 Quantities of the same kind within a given system of quantities have the same quantity dimension. However,
quantities of the same dimension are not necessarily of the same kind. The division of the concept of “quantity” according
to “kind-of-quantity” is to some extent arbitrary.
EXAMPLE 1 The quantities diameter, circumference and wavelength are generally considered to be quantities of the
same kind, namely of the kind-of-quantity called length.
EXAMPLE 2 The quantities number of entities, relative substance concentration, and mass fraction are, by convention,
not regarded as being of the same kind, although they have the same quantity dimension.
NOTE 4 Adapted from ISO/IEC Guide 99.
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SIST EN ISO 11240:2013
ISO 11240:2012(E)
3.1.13
mapping
alternative representation of the same concept expressed in a different code from a different code system
EXAMPLES Concept mapping, code mapping.
NOTE Because units of measurement represent defined physical quantities, this mapping is always exact. The
mapped terms represent exactly the same concept.
3.1.14
material measure
something that reproduces or supplies one or more quantities, each with an assigned quantity value
EXAMPLES Ruler, standard weight, volume measure.
3.1.15
measurement
process of experimentally obtaining one or more quantity values that can reasonably be attributed to a quantity
NOTE 1 Measurement does not apply to nominal properties.
NOTE 2 Measurement implies comparison of quantities and includes counting of entities.
NOTE 3 Measurement presupposes a description of the quantity commensurate with the intended use of a measurement
result, a measurement procedure, and a calibrated measuring system operating according to the specified measurement
procedure, including the measurement conditions.
NOTE 4 Measurement usually involves using a measuring instrument, such as a ruler or scale, which is calibrated to
compare the object to some standard, such as a metre or a kilogram.
NOTE 5 Adapted from ISO/IEC Guide 99.
3.1.16
measurement procedure
detailed description of a measurement according to one or more measurement principles (i.e. phenomena,
observables) and to a given measurement method, based on a measurement model and including any
calculation to obtain a measurement result
NOTE 1 A measurement procedure is usually documented in sufficient detail to enable an operator to perform a measurement.
NOTE 2 A measurement procedure can include a statement concerning a target measurement uncertainty.
NOTE 3 A measurement procedure is sometimes called a standard operating procedure, abbreviated SOP.
EXAMPLE Lowering of the concentration of glucose in blood in a fasting rabbit is an observable that can be applied
to the measurement of insulin concentration in a preparation. Together with a description of the measurement method this
can be used to define a measurement procedure.
NOTE 4 Adapted from ISO/IEC Guide 99.
3.1.17
medicinal product
any substance, or combination of substances, which may be administered to human beings for treating or preventing
disease, with the view to making a medical diagnosis or to restore, correct or modify physiological functions
NOTE 1 A medicinal product may contain one or more manufactured items and one or more pharmaceutical products.
NOTE 2 In certain jurisdictions a medicinal product may also be defined as any substance or combination of substances
which may be used to make a medical diagnosis.
NOTE 3 Adapted from ENV 13607:2000 and ENV 12610:1997.
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SIST EN ISO 11240:2013
ISO 11240:2012(E)
3.1.18
metrology
science of measurement and its application
NOTE Metrology includes all theoretical and practical aspects of measurement, whatever the measurement
uncertainty and field of application.
[ISO/IEC Guide 99:2007, definition 2.2]
3.1.19
numerical quantity value
numerical value of a quantity
numerical value
number in the expression of a quantity value, other than any number serving as the reference
NOTE 1 A number may serve as a “reference”. This can be explained by a dimensionless unit which appears as a
number. For example, the unit (1) or a “pair” (2), a “dozen” (12) or 1 percent (0,01), ppm etc.
NOTE 2 Adapted from ISO/IEC Guide 99.
3.1.20
pharmaceutical product
qualitative and quantitative composition of a medicinal product in the dose form authorized for administration
by a regulatory authority and as represented with any corresponding regulated product information
NOTE A medicinal product may contain one or more pharmaceutical products.
3.1.21
physical unit of measurement
unit of measurement that is defined using a physical quantity
NOTE 1 Its definition relates measured quantities to the base quantities through a set of well-defined equations.
NOTE 2 Physical units and their related scales are defined independently of the measurement procedure and the
measured components. They relate to an internationally standardized system of units and equations governing the
mathematical relations between those units.
3.1.22
prefix
word or symbol for attachment to the name or symbol of a unit in order to form units that are multiples or
submultiples of that unit
[27]
NOTE For more details, see chapter 3.1 of the International System
...