1、Dezember 2006DEUTSCHE NORM Normenausschuss Medizin (NAMed) im DINPreisgruppe 11DIN 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!,p“9775788www.din.deDDIN EN 1614Mediz
2、inische Informatik Darstellung von bestimmten Arten von Eigenschaften in derLaboratoriumsmedizin;Englische Fassung EN 1614:2006Health informatics Representation of dedicated kinds of property in laboratory medicine;English version EN 1614:2006Informatique de sant Reprsentation pure une dure forme de
3、 proprits dans le domaine des laboratoiresdanalyses mdicales;Version anglaise EN 1614:2006Alleinverkauf der Normen durch Beuth Verlag GmbH, 10772 BerlinErsatz frDIN V ENV 1614:1995-08www.beuth.deGesamtumfang 16 SeitenDIN EN 1614:2006-12 2 Nationales Vorwort Diese Norm enthlt unter Bercksichtigung de
4、s Beschlusses des Fachbereichs 7 den englischen Originaltext der europischen Norm EN 1614, Ausgabe 2006-09. Die Europische Norm wurde in der WG II Terminology and Knowledge Bases“ des CEN/TC 251 Medizinische Informatik“ (Sekretariat: NEN) erarbeitet. Der NA 063-07-03 AA Terminologie“ des Fachbereich
5、s 7 Medizinische Informatik“ des Normenausschusses Medizin im DIN hat an der Erarbeitung mitgewirkt. Das Dokument beschreibt ein Modell fr die Darstellung von bestimmten Arten von Eigenschaften in der Laboratoriumsmedizin. Das Modell soll die Nachrichtenverstndigung in Laborinformationssystemen, zwi
6、schen Laboratorien und zu anderen Informationssystemen des Gesundheitswesens erleichtern. nderungen Gegenber DIN V ENV 1614:1995-08 wurden folgende nderungen vorgenommen: a) der Vornormcharakter wurde aufgehoben; b) Verweise auf LOINC (Logical Observation Identifier Names and Codes) wurden aufgenomm
7、en; c) die Normativen Verweise auf IUPAC-IFCC C-NPU (Committee on Nomenclature, Properties and Units) wurden aufgehoben; d) das Verhltnis zwischen Typen und Instanzen von Eigenschaften wurde berarbeitet; e) die Norm wurde hinsichtlich ihres formalen und inhaltlichen Aufbaus berarbeitet. Frhere Ausga
8、ben DIN V ENV 1614: 1995-08 Folgende Begriffsliste wurde vom FB 7 erarbeitet und soll die Lesbarkeit des Dokumentes fr die Leser erhhen. Begriff in Englisch Begriff in Deutsch system System component Komponente property Eigenschaft quantity Gre aus VIM u. a. kind-of-property Arten von Eigenschaften
9、dedicated kind-of-property bestimmte Arten von Eigenschaften procedure Verfahren measurement scale Mastab der Messung unit of measurement unit Einheit; Maeinheit EUROPISCHE NORM EUROPEAN STANDARD NORME EUROPENNE EN 1614 September 2006 ICS 35.240.80 Ersatz fr ENV 1614:1995 Deutsche Fassung Medizinisc
10、he Informatik Darstellung von bestimmten Arten von Eigenschaften in der Laboratoriumsmedizin Health informatics Representation of dedicated kinds of property in laboratory medicine Informatique de sant Reprsentation pure une dure de proprits dans le domaine des laboratoires danalyses mdicales Diese
11、Europische Norm wurde vom CEN am 14. August 2006 angenommen. Die CEN-Mitglieder sind gehalten, die CEN/CENELEC-Geschftsordnung zu erfllen, in der die Bedingungen festgelegt sind, unter denen dieser Europischen Norm ohne jede nderung der Status einer nationalen Norm zu geben ist. Auf dem letzten Stan
12、d befindliche Listen dieser nationalen Normen mit ihren bibliographischen Angaben sind beim Management-Zentrum oder bei jedem CEN-Mitglied auf Anfrage erhltlich. Diese Europische Norm besteht in drei offiziellen Fassungen (Deutsch, Englisch, Franzsisch). Eine Fassung in einer anderen Sprache, die vo
13、n einem CEN-Mitglied in eigener Verantwortung durch bersetzung in seine Landessprache gemacht und dem Management-Zentrum mitgeteilt worden ist, hat den gleichen Status wie die offiziellen Fassungen. CEN-Mitglieder sind die nationalen Normungsinstitute von Belgien, Dnemark, Deutschland, Estland, Finn
14、land, Frankreich, Griechenland, Irland, Island, Italien, Lettland, Litauen, Luxemburg, Malta, den Niederlanden, Norwegen, sterreich, Polen, Portugal, Rumnien, Schweden, der Schweiz, der Slowakei, Slowenien, Spanien, der Tschechischen Republik, Ungarn, dem Vereinigten Knigreich und Zypern.EUROPISCHES
15、 KOMITEE FR NORMUNG EUROPEAN COMMITTEE FOR STANDARDIZATION COMIT EUROPEN DE NORMALISATIONManagement-Zentrum: rue de Stassart, 36 B-1050 Brssel 2006 CEN Alle Rechte der Verwertung, gleich in welcher Form und in welchem Verfahren, sind weltweit den nationalen Mitgliedern von CEN vorbehalten.Ref. Nr. E
16、N 1614:2006 DEN 1614:2006 (E) 2 Contents Page Foreword3 Introduction .4 1 Scope 5 1.1 Purpose.5 1.2 Field of application 6 1.3 Uses 6 1.4 Limitations6 2 Normative references 6 3 Terms and definitions .6 4 Requirements.7 4.1 Representation of dedicated kind-of-property .7 Annex A (informative) Repres
17、entation of dedicated kinds-of-property.9 Annex B (informative) C-NPU.12 Annex C (informative) LOINC .13 Bibliography 14 EN 1614:2006 (E) 3 Foreword This document (EN 1614:2006) has been prepared by Technical Committee CEN/TC 251 “Health informatics”, the secretariat of which is held by NEN. This Eu
18、ropean Standard shall be given the status of a national standard, either by publication of an identical text or by endorsement, at the latest by March 2007, and conflicting national standards shall be withdrawn at the latest by March 2007. This document supersedes ENV 1614:1995. The major technical
19、changes are that issues relating to the distinction between kinds and instances of property have been resolved and that normative references to IUPAC-IFCC C-NPU have been removed. According to the CEN/CENELEC Internal Regulations, the national standards organizations of the following countries are b
20、ound 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, Switzerla
21、nd and United Kingdom. EN 1614:2006 (E) 4 Introduction This European Standard provides a model for the representation of dedicated kinds of property in laboratory medicine. The need for this work stems from the increasing use of computerized clinical laboratory information systems, and the increasin
22、g need for reliable communication between laboratory information systems and between laboratory and other health care information systems (HCIS). Potential users of this European Standard are: international and national organizations responsible for development, maintenance or registration of nomenc
23、latures, classifications and coding systems; designers and developers of HCIS, e.g. laboratory information systems (LIS); persons responsible for acquisition of HCIS and checking compliance with standards; designers and developers of computerized diagnostic devices and data acquisition systems; deve
24、lopers of communication standards. The degree to which a message (such as a clinical laboratory report) needs to be expressed in a formal, systematic language depends on the geographical, linguistic, social or professional distance between the communicating parties. The greater the distance, the gre
25、ater the risk of misunderstanding. Within any one clinical laboratory, local jargon terms may be used which are usually well understood between colleagues (Local Dialect A in Figure 1), but which would not be sufficiently widely known for communication with the outside world. Likewise, a laboratory
26、and its local community of users, such as hospital or community physicians, may use a “local dialect“ of the language of clinical laboratories which is well understood by all concerned; but if communication possibilities are wider, even transnational, risks of serious misunderstanding arise. EN 1614
27、:2006 (E) 5 Figure 1 Reference terminology as the bridge between local dialects Risks of misunderstanding also increase when the “professional distance“ between communicating parties increases, e.g. laboratory to health administrator rather than laboratory to clinician. Two approaches to reducing th
28、is risk are: 1. To standardize the technical language used by clinical laboratory workers, users of the service, and other interested parties throughout the whole area in which communications may take place by eliminating all “local dialects“. This is obviously impracticable. Laboratory workers and
29、clinicians would object to any such attempt from medical informatics. In the long run, agreement between professional bodies, with the cooperation of educational institutions, may lead to a greater degree of uniformity in the language of clinical laboratories, but this will not happen quickly and ca
30、nnot be forced. 2. To create a coding scheme and a reference terminology for laboratory medicine which can be used as the basis for coding the dedicated kind-of-property part of a clinical laboratory messages for transmission between different locations and which contains sufficient information to a
31、llow the message to be translated from and to the required “local dialect“ at each end. The coding scheme should be based on a standardized representation structure. This is the more practical approach. 1 Scope 1.1 Purpose This European Standard provides a structure aiding the representation, e.g. s
32、ystematic terms or coding systems, of dedicated kinds of property, including dedicated kinds of quantity, in laboratory medicine. The structure for representation is intended to facilitate the unambiguous communication of messages containing information about properties. EN 1614:2006 (E) 6 1.2 Field
33、 of application This European Standard is applicable to all branches of laboratory medicine and other bodies offering laboratory analytic services. Examinations performed in the physicians office, at the bedside, or in the home are considered to be part of the laboratory medicine domain and thus thi
34、s European Standard applies. 1.3 Uses This structure for representation constitutes the essential basis for development of nomenclatures and coding systems intended for use in unambiguous and fully informative communication about properties, which fall within the field of application. Every such com
35、munication, including requests to and reports from clinical laboratories, and information retrieval for management reporting, research and reimbursement, will require additional information which is outside the scope of this European Standard. 1.4 Limitations It should be emphasized that it is not t
36、he purpose of this European Standard to standardize the language used by health care practitioners in requesting or reporting clinical laboratory data. It may, however, be used as a guide by those who wish to adopt systematic terms for routine requesting and reporting of laboratory data. The syntax
37、used for representing dedicated kinds-of-property is outside the scope of this European Standard, as are syntactic rules for the construction of codes in coding schemes. The purpose is not to standardize the presentation of properties or kinds-of-property in user interfaces of computer systems nor t
38、he presentation in printed documents. 2 Normative references Not applicable. 3 Terms and definitions For the purposes of this document, the following terms and definitions apply. 3.1 system part or phenomenon of the perceivable or conceivable world consisting of a demarcated arrangement of a set of
39、elements and a set of relationships or processes between these elements 1 EXAMPLE A given human being; a given portion of urine; the blood of a given person. NOTE A system is, with the exception of the universe, a part of at least one more comprehensive super system and can itself contain one or sev
40、eral subsystems. 3.2 component part of a system (3.1) EXAMPLE Body of a given human being; glucose in a given portion of urine; the process of coagulation of the blood of a given person. NOTE 1 Systems are open, i.e. transport occurs across their borders, both as input and output. Such transported e
41、ntities may be conveniently regarded as components of the system. NOTE 2 Components may be complex in that they may be aggregates of other components. EN 1614:2006 (E) 7 3.3 property inherent state- or process-descriptive feature of a system (3.1) including any pertinent component (3.2) being determ
42、ined EXAMPLE Mass of the body of a given person at a given point in time; amount-of-substance concentration of glucose in a portion of urine at a given point in time. 3.4 quantity attribute of a phenomenon, body or substance that may be distinguished qualitatively and determined quantitatively VIM E
43、XAMPLE Mass of a given object at a given point in time. NOTE 1 Quantity is more specific in relation to property (3.3). NOTE 2 The adjectives “measurable“ and “physical“ are used in VIM and in ISO 31, respectively, when required to point out that the word “quantity“ is used in its metrological sense
44、. In general, these adjectives can be omitted. 3.5 kind-of-property common defining aspect of mutually comparable properties (3.3) 1 EXAMPLE Colour; mass; amount-of-substance concentration. NOTE The hyphens are used to clarify that the modifier “kind“ should be seen as part of a connected whole. 3.6
45、 dedicated kind-of-property kind-of-property (3.5) with a given kind of system (3.1) and a given kind of component (3.2) subject for determination EXAMPLE Mass of the body of a non-specified human being; amount-of-substance concentration of glucose in urine. 3.7 procedure specified way to carry out
46、an activity or a process 9 3.8 measurement scale ordered set of values of quantities of a given kind, continuous or discrete, used in arranging quantities of the same kind by magnitude 12 3.9 unit scalar quantity, defined and adopted by convention, with which other quantities of the same kind are co
47、mpared in order to express their magnitudes 12 4 Requirements 4.1 Representation of dedicated kind-of-property The following elements stemming from the ontology of property shall be used for the representation of dedicated kinds-of-property (3.6) in laboratory medicine: kind of system (3.1); EN 1614
48、:2006 (E) 8 kind of component (3.2); kind-of-property (3.5). Representations of additional entities shall be appended to any or all of the elements when this is necessary to further specify the dedicated kind-of-property (3.6) to the degree required for a given purpose. While the three elements abov
49、e represent aspects of the property examined, other aspects related to the examination of the property or the representation of the value of the property may need to be specified. Thus, a representation of a dedicated kind-of-property (3.6) may be further specified by: procedure (3.7); measurement scale (3.8); unit (3.9). EXAMPLE Specification to the system plasma, may be the super-system venous blood; to the component chromium, the specification Stock notation IV; to the kind-of-property
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