BS EN 12435-2006 Health informatics - Expression of results of measurements in health sciences《健康信息学 健康科学中测量结果的表达方式》.pdf

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1、 g49g50g3g38g50g51g60g44g49g42g3g58g44g55g43g50g56g55g3g37g54g44g3g51g40g53g48g44g54g54g44g50g49g3g40g59g38g40g51g55g3g36g54g3g51g40g53g48g44g55g55g40g39g3g37g60g3g38g50g51g60g53g44g42g43g55g3g47g36g58health sciencesThe European Standard EN 12435-1:2006 has the status of a British StandardICS 11.020

2、; 35.240.70Health informatics Expression of results of measurements in BRITISH STANDARDBS EN 12435:2006BS EN 12435:2006This British Standard was published under the authority of the Standards Policy and Strategy Committee on 30 June 2006 BSI 2006ISBN 0 580 48842 XThe United Kingdom as a member of CE

3、N is obliged to publish EN 12435:2006 as a British Standard. However, attention is drawn to the following concerns that led the United Kingdom to vote against its approval as an EN. Whilst referenced in the bibliography (reference 45) it is the opinion of UK Committee IST/35 that no substantive cons

4、ideration is made to the Unified Code for Units of Measure (UCUM). UCUM provides a consistent, computationally useful representation of units of measurement. The United Kingdom concern is that without an exhaustive comparison and alignment between the content of EN 12435 and UCUM, unanticipated issu

5、es of measurement unit interoperability and computational transformation may be encountered. Cross-referencesThe British Standards which implement international or European publications referred to in this document may be found in the BSI Catalogue under the section entitled “International Standards

6、 Correspondence Index”, or by using the “Search” facility of the BSI Electronic Catalogue or of British Standards Online.This publication does not purport to include all the necessary provisions of a contract. Users are responsible for its correct application. Compliance with a British Standard does

7、 not of itself confer immunity from legal obligations.Summary of pagesThis document comprises a front cover, an inside front cover, the EN title page, pages 2 to 116, an inside back cover and a back cover.The BSI copyright notice displayed in this document indicates when the document was last issued

8、.Amendments issued since publicationAmd. No. Date CommentsA list of organizations represented on this committee can be obtained on request to its secretary. present to the responsible international/European committee any enquiries on the interpretation, or proposals for change, and keep UK interests

9、 informed; monitor related international and European developments and promulgate them in the UK.National forewordThis British Standard is the official English language version of EN 12435:2006. It supersedes DD ENV 12435:1999 which is withdrawn.The UK participation in its preparation was entrusted

10、to Technical Committee IST/35, Health informatics, which has the responsibility to: aid enquirers to understand the text;EUROPEAN STANDARDNORME EUROPENNEEUROPISCHE NORMEN 12435January 2006ICS 11.020; 35.240.70 Supersedes ENV 12435:1999 English VersionHealth informatics - Expression of results of mea

11、surements inhealth sciencesInformatique de sant - Expression des rsultats demesure dans le domaine de la santMedizinische Informatik - Darstellung der Ergebnisse vonMessungen in den GesundhetswissenschaftenThis European Standard was approved by CEN on 14 December 2005.CEN members are bound to comply

12、 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 concerning such nationalstandards may be obtained on application to the Central Secreta

13、riat 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 language and notified to the Central Secretariat has the same status as the officialv

14、ersions.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, Swed

15、en, Switzerland and United Kingdom.EUROPEAN COMMITTEE FOR STANDARDIZATIONCOMIT 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.

16、 No. EN 12435:2006: EEN 12435:2006 (E) 2 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 f

17、or 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.

18、 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

19、 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) Convers

20、ion 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 EN 12435:2006 (E) 3 Foreword This document (EN 12435:2006) has been prepared by Technical

21、 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 publicat

22、ion 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

23、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, Sw

24、eden, Switzerland and United Kingdom. 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 ways of expressing their results. Conventions within user

25、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 t

26、he 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 implem

27、ent 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 Haemat

28、ology, 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 countr

29、ies 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

30、 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. EN 12435

31、: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 systems. It provides a list of units of measurement to be used in representing values of measurable quantities in health sci

32、ences. 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 d

33、ifferent 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 fo

34、r 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 su

35、pport 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, speec

36、h 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 recordin

37、g 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 indis

38、pensable 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 p

39、hysical sciences and technology. EN 12435:2006 (E) 6 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 bas

40、e 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 (a

41、fter 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 ana

42、lyte. 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

43、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

44、 ISO 8402:1994 EN 12435:2006 (E) 7 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 processes, or any combination of such (detected, for instance, by

45、pattern recognition). NOTE 2 The concept 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

46、 of the specification of a component (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 count

47、ing 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 NOTE Factor prefixes provide a series to allow submultiples and multiples of SI units in the range 10-24

48、to 1024. 3.1.12 graphic character character in its visible representation ISO 10 646-1 3.1.13 interchange transfer of character-coded data from one user to another, using telecommunication means or interchangeable carriers (after ISO 10 646-1) 3.1.14 International System of Units (SI) coherent syste

49、m of units adopted and recommended by the General Conference on Weights and Measures (VIM) 3.1.15 kind-of-quantity element of information common to a set of mutually comparable measurable quantities and necessary for the definition of a measurable quantity, along with a system and often a component NOTE 1 The definition of this concept is under discussion in ISO/TC12. NOTE 2 The unqualified word quantity is also widely used for this concept, which VIM calls quantity in a general sense. NOTE 3 A kind-of-quantity