EN 12435:2006
(Main)Health informatics - Expression of results of measurements in health sciences
Health informatics - Expression of results of measurements in health sciences
This document is intended for use by parties to the design, development, acquisition, use and monitoring of health-care related information and information systems. It provides a list of units of measurement to be used in representing values of measurable quantities in health sciences.
The International System of Units forms the basis for this EN. Units with their associated kinds-of-quantity are arranged in order of dimension in Tables 1, 2 and 4 (Clause 5), and in Annex A.
Different kinds-of-quantity may apply to a given combination of component(s) and system. Often the different quantities are interconvertible and examples of such interconvertibility are given in Annex C.
Tables of conversion factors (Annex A) are provided from units in current use to SI units or their multiples.
To represent the result of a measurement (Clause 6), this EN addresses requirements for the following:
¾ relational operator (Clause 4)
¾ numerical value (Subclause 6.1)
¾ uncertainty of measurement (Subclause 6.2; Annex D)
¾ unit of measurement (Clause 5).
This EN covers the requirements for representation of these data elements in displayed and printed form, and provides an approach for support of languages in non-Roman alphabets (Clause 7).
The scope of this standard is limited to textual representation. Support is not provided for the display or printing of images or graphs.
This standard does not cover the requirements for expression of the results of measurements in speech, speech synthesis or handwriting. It does not cover the form and syntax of requests for clinical measurements, nor detailed aspects of data transmission. It refers the user to other CEN standards that address the detailed specification of the interchange format. It does not address the syntax for recording of natural-language statements about quantities, such as those used in recording information about drugs dispensed or about treatment of patients. It does not cover the units of financial quantitie
Medizinische Informatik - Darstellung der Ergebnisse von Messungen in den Gesundheitswissenschaften
Informatique de santé - Expression des résultats de mesure dans le domaine de la santé
Zdravstvena informatika – Prikaz rezultatov meritev v medicinskih znanostih
General Information
Relations
Standards Content (Sample)
SLOVENSKI STANDARD
01-april-2006
1DGRPHãþD
SIST ENV 12435:2003
Zdravstvena informatika – Prikaz rezultatov meritev v medicinskih znanostih
Health informatics - Expression of results of measurements in health sciences
Medizinische Informatik - Darstellung der Ergebnisse von Messungen in den
Gesundheitswissenschaften
Informatique de santé - Expression des résultats de mesure dans le domaine de la santé
Ta slovenski standard je istoveten z: EN 12435:2006
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.
EUROPEAN STANDARD
EN 12435
NORME EUROPÉENNE
EUROPÄISCHE NORM
January 2006
ICS 11.020; 35.240.70 Supersedes ENV 12435:1999
English Version
Health informatics - Expression of results of measurements in
health sciences
Informatique de santé - Expression des résultats de Medizinische Informatik - Darstellung der Ergebnisse von
mesure dans le domaine de la santé Messungen in den Gesundhetswissenschaften
This European Standard was approved by CEN on 14 December 2005.
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 Central Secretariat 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 Central Secretariat has the same status as the official
versions.
CEN members are the national standards bodies of Austria, Belgium, Cyprus, Czech Republic, Denmark, Estonia, Finland, France,
Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania,
Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION
EUROPÄISCHES KOMITEE FÜR NORMUNG
Management Centre: rue de Stassart, 36 B-1050 Brussels
© 2006 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN 12435:2006: E
worldwide for CEN national Members.
Contents
Foreword. 3
Introduction . 4
1 Scope. 5
2 Normative references. 5
3 Definitions, abbreviations and acronyms. 6
3.1 Definitions. 6
3.2 Abbreviations, initialisms and acronyms . 9
4 Elements of data in a measurable quantity and its result . 10
5 Units for reporting information in health sciences . 11
5.2 Derived coherent units of SI and mathematical operations with units. 12
5.3 Derived coherent units of SI with special names and symbols . 13
5.4 Multiples and submultiples of units: prefix names and symbols . 13
5.5 Units outside SI: off-system units. 17
5.6 Units of dimensionless quantities and compound units with the unit `one' in the
numerator. 19
6 Expression of numerical value and uncertainty. 21
6.1 Numerical values. 21
6.1 Numerical values. 21
6.2 Uncertainty of measurement. 22
7 Representation of the results of measurement. 22
7.1 Display and printing . 22
7.2 Transmission and storage . 23
8 Deprecation of the use of "limited" (e.g. 7-bit) character sets. 24
Annex A (informative) Table of kinds-of-quantity, their units and conversion factors
(informative). 25
Annex B (informative) Dimension of a quantity. 103
Annex C (informative) Conversion between kinds-of-quantity. 104
Annex D (normative) Uncertainty of measurement . 107
Annex E (normative) Rounding numerical values . 109
Annex F (informative) Non-measurable properties . 113
Bibliography . 114
Foreword
This document (EN 12435:2006) has been prepared by Technical Committee CEN/ TC 251 "Health
informatics", the secretariat of which is held by NEN.
This document falls under mandate BC/CEN/03/ 255/97/23 of the European Commission and the
European Free Trade Association.
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 July 2006, and conflicting national standards shall be
withdrawn at the latest by July 2006.
This document supersedes ENV 12435:1999.
According to the CEN/CENELEC Internal Regulations, the national standards organizations of the
following countries are bound to implement this European Standard: Austria, Belgium, Cyprus, Czech
Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy,
Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia,
Slovenia, Spain, Sweden, Switzerland and United Kingdom.
Introduction
Results of measurements on the human or animal body, and its environment are essential in the
health sciences. The disciplines involved in measurement often use different ways of expressing their
results. Conventions within user groups are not universally applicable. 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 must therefore be reached on how
to express the results of measurements on the body and its environment, particularly for exchange
between information systems.
Universal principles for the expression of measurements have been laid down by Technical
Committee 12 of the International Organization for Standardization in its series of standards ISO 31
and ISO 1000, which implement the International System of Units (SI) defined by the General
Conference on Weights and Measures. Those principles have been applied to biological systems and
certain units have been added by the International Council on Radiological Protection, International
Council on Standardization in Haematology, the International Federation of Clinical Chemistry, the
International Union of Biochemistry and Molecular Biology, the International Union of Pure and
Applied Chemistry and the World Health Organization. Implementation of this EN will provide wider
comprehension and interaction between countries and specialities.
The main normative provisions of this European standard are expressed in Clauses 5, 6 and 7. They
include the following aspects of the performance of a device or system related to the result of a
measurement:
the selection of kind-of-quantity and the unit in which to express it in accordance with the
provisions of Clause 5
where reported, the uncertainty of the value in accordance with the provisions of Annex D
for the purposes of display, printing, transmission and storage, the elements of the results of
measurement in accordance with the provisions of Clause 7.
1 Scope
This document is intended for use by parties to the design, development, acquisition, use and monitoring
of health-care related information and information systems. It provides a list of units of measurement to
be used in representing values of measurable quantities in health sciences.
The International System of Units forms the basis for this EN. Units with their associated kinds-of-quantity
are arranged in order of dimension in Tables 1, 2 and 4 (Clause 5), and in Annex A.
Different kinds-of-quantity may apply to a given combination of component(s) and system. Often the
different quantities are interconvertible and examples of such interconvertibility are given in Annex C.
Tables of conversion factors (Annex A) are provided from units in current use to SI units or their multiples.
To represent the result of a measurement (Clause 6), this EN addresses requirements for the following:
relational operator (Clause 4)
numerical value (Subclause 6.1)
uncertainty of measurement (Subclause 6.2; Annex D)
unit of measurement (Clause 5).
This EN covers the requirements for representation of these data elements in displayed and printed form,
and provides an approach for support of languages in non-Roman alphabets (Clause 7).
The scope of this standard is limited to textual representation. Support is not provided for the display or
printing of images or graphs.
This standard does not cover the requirements for expression of the results of measurements in speech,
speech synthesis or handwriting. It does not cover the form and syntax of requests for clinical
measurements, nor detailed aspects of data transmission. It refers the user to other CEN standards that
address the detailed specification of the interchange format. It does not address the syntax for recording
of natural-language statements about quantities, such as those used in recording information about drugs
dispensed or about treatment of patients. It does not cover the units of financial quantities, which are
covered by ISO 4217.
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 31-11:1992, Quantities and units – Part 11: Mathematical signs and symbols for use in the
physical sciences and technology.
3 Definitions, abbreviations and acronyms
3.1 Definitions
3.1.1
base kind-of-quantity
one of the kinds-of-quantity that, in a system of kinds-of-quantity, are conventionally accepted as
functionally independent of one another (after VIM)
3.1.2
base unit
unit of measurement of a base kind-of-quantity in a given system of kinds-of-quantity (after VIM)
3.1.3
character
member of a set of elements used for the organization, control or representation of information (after
ISO 10 646-1)
3.1.4
coded character
character in its coded representation (after ISO 10 646-1)
3.1.5
coherent unit
derived unit of measurement that may be expressed as a product of powers of base units with the
proportionality factor one (VIM)
3.1.6
component
definable part of a system (ENV 1614)
NOTE In analytical chemistry, component is sometimes called constituent or analyte.
3.1.7
derived kind-of-quantity
kind-of-quantity defined, in a system of kinds-of-quantity, as a function of base kinds-of-quantity of
that system (after VIM)
3.1.8
derived unit
unit of measurement of a derived kind-of-quantity in a given system of kinds-of-quantity (after VIM)
3.1.9
dimension of quantity
expression that represents a quantity in a system of quantities as the product of powers of factors that
represent the base kinds-of-quantity of the system (after VIM)
NOTE The use of this term is explained in Annex B.
3.1.10
entity
that which can be individually described and considered
[ISO 8402:1994]
NOTE 1 The word unit is used for this concept in statistics and in counting for what is counted, which may be,
for instance, physical objects, physical particles, repetitive operations or repetitive proces
...
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