DIN EN 12435-2006 Health Informatics - Expression of results of measurements in health sciences English version EN 12435 2006《医疗信息学 健康科学测量结果表达式》.pdf

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1、September 2006DEUTSCHE NORM Normenausschuss Medizin (NAMed) im DINPreisgruppe 32DIN Deutsches Institut fr Normung e.V. Jede Art der Vervielfltigung, auch auszugsweise, nur mit Genehmigung des DIN Deutsches Institut fr Normung e.V., Berlin, gestattet.ICS 35.240.80!,jw“9718492www.din.deDDIN EN 12435Me

2、dizinische Informatik Darstellung der Ergebnisse von Messungen in denGesundheitswissenschaften;Englische Fassung EN 12435:2006Health Informatics Expression of results of measurements in health sciences;English version EN 12435:2006Informatique de sant Expression des rsultats de mesure dans le domain

3、e de la sant;Version anglaise EN 12435:2006Alleinverkauf der Normen durch Beuth Verlag GmbH, 10772 BerlinErsatz frDIN V ENV 12435:2000-02www.beuth.deGesamtumfang 118 SeitenB55EB1B3E14C22109E918E8EA43EDB30F09CC9B7EF8DD9NormCD - Stand 2007-03 DIN EN 12435:2006-09 2 Nationales Vorwort Diese Norm enthlt

4、 unter Bercksichtigung des Prsidialbeschlusses 13/1983 den englischen Originaltext der Europischen Norm EN 12435, Ausgabe 2006-01. Diese Europische Norm wurde in der WG II Terminology and knowledge representation des CEN/TC 251 Medizinische Informatik erarbeitet. Der Arbeitsausschuss NA 063-07-03 AA

5、 Terminologie des Fachbereichs 7 Medizinische Informatik des Normenausschusses Medizin im DIN hat an der Erarbeitung mitgewirkt. Diese Norm legt die Darstellung der Ergebnisse von Messungen in den Gesundheitswissenschaften fest, wobei auf vorhandene Systeme zurckgegriffen wird. Fr die im Abschnitt 2

6、 zitierten Internationalen Normen wird im Folgenden auf die entsprechenden Deutschen Normen hingewiesen: ISO 31 siehe DIN 1302 (modifiziert) nderungen Gegenber DIN V ENV 12435:2000-02 wurden folgende nderungen vorgenommen: a) der Vornormcharakter wurde aufgehoben; b) der Inhalt wurde redaktionell be

7、rarbeitet. Frhere Ausgaben DIN V ENV 12435:2000-02 Nationaler Anhang NA (informativ) Literaturhinweise DIN 1302:1994-04, Allgemeine mathematische Zeichen und Begriffe (Ersetzt durch DIN 1302:1999-12) B55EB1B3E14C22109E918E8EA43EDB30F09CC9B7EF8DD9NormCD - Stand 2007-03 EUROPEAN STANDARDNORME EUROPENN

8、EEUROPISCHE NORMEN 12435January 2006ICS 11.020; 35.240.70 Supersedes ENV 12435:1999 English VersionHealth informatics - Expression of results of measurements inhealth sciencesInformatique de sant - Expression des rsultats demesure dans le domaine de la santMedizinische Informatik - Darstellung der E

9、rgebnisse vonMessungen in den GesundheitswissenschaftenCEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this EuropeanStandard the status of a national standard without any alteration. Up-to-date lists and bibliographical references c

10、oncerning such nationalstandards 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 translationunder the responsibility of a CEN member into its own

11、 language and notified to the Central Secretariat has the same status as the officialversions.CEN members are the national standards bodies of Austria, Belgium, Cyprus, Czech Republic, Denmark, Estonia, Finland, France,Slovenia, Spain, Sweden, Switzerland and United Kingdom.EUROPEAN COMMITTEE FOR ST

12、ANDARDIZATIONCOMIT EUROPEN DE NORMALISATIONEUROPISCHES KOMITEE FR NORMUNGManagement Centre: rue de Stassart, 36 B-1050 Brussels 2006 CEN All rights of exploitation in any form and by any means reservedworldwide for CEN national Members.Ref. No. EN 12435:2006: EThis European Standard was approved by

13、CEN on 14. December 2005.Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania,Slovakia,B55EB1B3E14C22109E918E8EA43EDB30F09CC9B7EF8DD9NormCD - Stand 2007-03 EN 12435:2006 (E) 2 Contents Foreword 3 Introduction . 4 1 Sc

14、ope. 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 an

15、d 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

16、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 “limi

17、ted“ (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

18、. 107 Annex E (normative) Rounding numerical values . 109 Annex F (informative) Non-measurable properties . 113 Bibliography 114 B55EB1B3E14C22109E918E8EA43EDB30F09CC9B7EF8DD9NormCD - Stand 2007-03 EN 12435:2006 (E) 3 Foreword This document (EN 12435:2006) has been prepared by Technical Committee CE

19、N/ 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 ide

20、ntical 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

21、 bound to implement this European Standard: Austria, Belgium, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Spain, Sweden, Switzerland and United Kingdom. Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Roma

22、nia, Slovakia, Slovenia, B55EB1B3E14C22109E918E8EA43EDB30F09CC9B7EF8DD9NormCD - Stand 2007-03 EN 12435:2006 (E) 4 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 wa

23、ys 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 re

24、ached 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 i

25、ts 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 Protec

26、tion, 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 pr

27、ovide 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

28、 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

29、 in accordance with the provisions of Clause 7. B55EB1B3E14C22109E918E8EA43EDB30F09CC9B7EF8DD9NormCD - Stand 2007-03 EN 12435:2006 (E) 5 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

30、 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 (Cl

31、ause 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 curre

32、nt 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 cov

33、ers 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 i

34、mages 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

35、 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 unit

36、s 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 (inc

37、luding any amendments) applies. ISO 31-11:1992, Quantities and units Part 11: Mathematical signs and symbols for use in the physical sciences and technology. B55EB1B3E14C22109E918E8EA43EDB30F09CC9B7EF8DD9NormCD - Stand 2007-03 EN 12435:2006 (E) 6 3 Definitions, abbreviations and acronyms 3.1 Definit

38、ions 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

39、.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 p

40、owers 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 func

41、tion 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 fa

42、ctors 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 B55EB1B3E14C22109E918E8EA43EDB30F09CC9B7EF8DD9NormCD - Stand 2007-03 EN 12435:2006 (E) 7 NO

43、TE 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 processes, or any combination of such (detected, for instance, by pattern recognition). NOTE 2 The conc

44、ept is called element in set theory, in which a collection of elements constitute a set: element - set In this context, a component may be considered as a set of entities: entity - component NOTE 3 An entity, in contrast to a unit of measurement, constitutes part of the specification of a component

45、(on the left side of the equation in Subclause 4.2) and not part of the unit of measurement (on the right side of the equation). The entity thus forms part of the specification of the measurable quantity. Some examples of such measurable quantities based on counting are given in Subclause 5.6.5. 3.1.11 factor prefix 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