1、Mai 2006DEUTSCHE NORM Normenausschuss Medizin (NAMed) im DINPreisgruppe 37DIN 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!,dC“9659532www.din.deDDIN EN 14822-3Medizi
2、nische Informatik Allgemein verwendbare Informationskomponenten Teil 3: Klinische Informationen;Englische Fassung EN 14822-3:2005Health informatics General purpose information components Part 3: Clinical;English version EN 14822-3:2005Informatique de sant Unit dinformation dans les messages Partie 3
3、: Clinique;Version anglaise EN 14822-3:2005Alleinverkauf der Normen durch Beuth Verlag GmbH, 10772 Berlin www.beuth.deGesamtumfang 212 SeitenB55EB1B3E14C22109E918E8EA43EDB30F09CC9B7EF8DD9NormCD - Stand 2007-03 DIN EN 14822-3:2006-05 2 Nationales Vorwort Diese Norm enthlt unter Bercksichtigung des Pr
4、sidialbeschlusses 13/1983 den englischen Originaltext der Europischen Norm EN 14822-3:2005-10. Die Europische Norm wurde in der WG I Information Models“ des CEN/TC 251 Medizinische Informatik“ erarbeitet, dessen Sekretariat vom NEN (Niederlande) gehalten wird. Der Arbeitsausschuss NA 063-07-02 AA In
5、teroperabilitt“ des Fachbereichs 07 Medizinische Informatik“ des Normenausschusses Medizin im DIN hat an der Erarbeitung mitgewirkt. Diese Europische mehrteilige Norm legt generelle Anforderungen fr allgemein verwendbare Informationskomponenten, die in Normen zum Datenaustausch eingesetzt werden, un
6、ter gesundheits-spezifischen Aspekten fest. Die Komponenten die durch diese Norm festgelegt werden, sind die am hufigsten gebrauchten, grundlegenden Bausteine fr derartige Normen. Diese knnen allerdings weitere Spezialisierungen und Ergnzungen fr bestimmte Anwendungen bentigen, die nicht durch die h
7、ier beschriebenen generell anwendbaren Komponenten abgedeckt werden. In diesem Teil werden die klinischen Daten beschrieben, insbesondere die Daten zu den zu analysierenden Objekten, medizinischen Informationen, Medizinprodukten, Angaben zur Medikation und anderen Manahmen sowie Informationen zu Ges
8、undheitsdienstleistungen. Der Begriff klinisch“ beschreibt hier alle medizinischen Daten und geht ber den klinikinternen Verwendungszweck hinaus und gilt insbesondere auch fr den ambulanten Bereich. Die Komponenten sollen gerade auch sektorenbergreifend benutzt werden. B55EB1B3E14C22109E918E8EA43EDB
9、30F09CC9B7EF8DD9NormCD - Stand 2007-03 EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN 14822-3 October 2005 ICS 35.240.80 English Version Health informatics General purpose information components Part 3: Clinical Informatique de sant Unit dinformation dans les messages Partie 3: Clinique Medizi
10、nische Informatik Allgemein verwendbare Informationskomponenten Teil 3: Klinische InformationenThis European Standard was approved by CEN on 16 August 2005. CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this European Standard the
11、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).
12、 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
13、, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom. EUROPEAN COMMITTEE FOR STANDARDIZATION COMIT EUROPEN DE NORMALISATION EUROPIS
14、CHES KOMITEE FR NORMUNG Management Centre: rue de Stassart, 36 B-1050 Brussels 2005 CEN All rights of exploitation in any form and by any means reserved worldwide for CEN national Members. Ref. No. EN 14822-3:2005: EB55EB1B3E14C22109E918E8EA43EDB30F09CC9B7EF8DD9NormCD - Stand 2007-03 EN 14822-3:2005
15、 (E) 2 Contents Page Foreword4 Introduction .5 1 Scope 6 2 Normative references 6 3 Terms and definitions .6 4 Abbreviations 10 5 Rules governing the use of general purpose information components. 10 6 General Purpose Information Components an overview 12 7 General Purpose Information Components . 2
16、0 7.1 Analysable Object GPICs. 20 7.1.1 Analysable Object. 20 7.1.2 Analysable Object In Use. 24 7.1.3 Specimen. 26 7.1.4 Related Analysable Object. 31 7.1.5 Manufactured Specimen 32 7.1.6 Specimen Treatment 35 7.1.7 Related Specimen Treatment 38 7.1.8 Associated Specimen Treatment 39 7.1.9 Study Pr
17、oduct . 41 7.1.10 Object Characteristic 44 7.1.11 Preservation Material . 46 7.1.12 Acquired Analysable Object 49 7.1.13 Analysable Object Acquisition 51 7.1.14 Related Object Acquisition 52 7.1.15 Acquisition Procedure . 54 7.1.16 External Data Reference 59 7.2 Clinical Information GPICs 61 7.2.1 C
18、linical Information 61 7.2.2 Clinical Information Complex 63 7.2.3 Clinical Information Context 66 7.2.4 Related Clinical Information Complex 68 7.2.5 Clinical Information Item 70 7.2.6 Related Clinical Information 74 7.3 Clinical Observation GPICs . 75 7.3.1 Clinical Observation . 75 7.3.2 Related
19、Patient Condition 78 7.4 Clinical Procedure GPICs 80 7.4.1 Clinical Procedure 80 7.4.2 Patient Preparation Procedure 84 7.4.3 Patient Preparation Substance 88 7.5 Counselling GPICs 89 7.5.1 Counselling . 89 7.6 Unclassified Clinical Information GPICs 92 7.6.1 Unclassified Clinical Information 92 7.7
20、 Laboratory And Diagnostic Investigation GPICs 95 7.7.1 Investigation Request 95 7.7.2 Related Investigation Request 101 7.7.3 Investigation Result Item . 103 7.7.4 Related Investigation Result 107 7.7.5 Reference Limit. 109 B55EB1B3E14C22109E918E8EA43EDB30F09CC9B7EF8DD9NormCD - Stand 2007-03 EN 148
21、22-3:2005 (E) 3 Page 7.7.6 Reference Population111 7.7.7 Investigation Specification.113 7.7.8 Body System117 7.7.9 Related Body System119 7.7.10 Measurement Procedure.121 7.8 Medication GPICs124 7.8.1 Utilisation Guide124 7.8.2 Medication Treatment .125 7.8.3 Medication Supply.128 7.8.4 Medicinal P
22、roduct132 7.8.5 Ingredient .135 7.8.6 Medicinal Product in Use137 7.8.7 Medicinal Product Pack 139 7.8.8 Medicinal Product Pack in Use 143 7.8.9 Medication Appliance145 7.8.10 Medication Appliance in Use147 7.8.11 Medication Treatment Regimen .148 7.8.12 Dose Administration .150 7.8.13 Medication Tr
23、eatment Condition .154 7.9 Treatment Routing GPICs.156 7.9.1 Routing Option 156 7.9.2 Routing Device 158 Care Encounter GPICs.161 7.9.3 Care Service Request161 7.9.4 Related Service Request.165 7.9.5 Care Service Report 166 7.9.6 Related Service Report .170 7.9.7 Care Encounter172 7.9.8 Related Care
24、 Encounter176 7.10 Care Service Delivery GPICs178 7.10.1 Care Service Delivery178 7.10.2 Previous Related Activity .181 8 Acts, their context and inheritance .183 8.1 Introduction183 8.2 Inheritance of Act Context184 8.2.1 Method184 8.2.2 Participation.184 8.2.3 Act Relationship 185 9 Structural voc
25、abularies.187 9.1 Act class.187 9.2 Act mood 192 9.3 Act status .193 9.4 Act Relationship 193 9.5 Context Control Act Relationship198 9.6 Context Control Participation 198 Annex A (informative) Rationale for this document on general purpose information components199 Annex B (informative) How to read
26、 the models .200 B.1 Introduction200 B.2 Classes .200 B.3 Associations between classes.200 B.4 Generalisation/Specialisation 201 Annex C (informative) Health Level 7 (HL7) reference information model .202 Annex D (informative) Common features of the general purpose information components204 Annex E
27、(informative) Localisation of the general purpose information components206 Bibliography207 B55EB1B3E14C22109E918E8EA43EDB30F09CC9B7EF8DD9NormCD - Stand 2007-03 EN 14822-3:2005 (E) 4 Foreword This European Standard (EN 14822-3:2005) has been prepared by Technical Committee CEN/TC 251 Health informat
28、ics, 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 April 2006, and conflicting national standards shall be withdrawn at the latest by April 2006. This is
29、 part three of a multipart standard under the heading: Health informatics - General purpose information components: Part 1: Overview Part 2: Non-clinical Part 3: Clinical This European Standard is definition of a set of clinical general purpose information components. IMPORTANT Within this draft doc
30、ument each of the General Purpose Information Components and various sub-components are provided with identifiers, which are unique only internally within this European Standard. According to the CEN/CENELEC Internal Regulations, the national standards organizations of the following countries are bo
31、und 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, Slovakia, Slovenia, Spain, Sweden, Switzerland and Uni
32、ted Kingdom. B55EB1B3E14C22109E918E8EA43EDB30F09CC9B7EF8DD9NormCD - Stand 2007-03 EN 14822-3:2005 (E) 5 Introduction Many previous messaging and information structure standards for health have overlapping parts with a number of objects being defined in separate documents, sometimes with small variat
33、ions making implementation of conformant applications more difficult. It therefore makes sense to define a set of general purpose components that can be used for definition of message structures for different purposes1. This approach was suggested and approved as a strategy for CEN/TC 251 in the Sho
34、rt Strategic Study on message standards alignment in 1999 examining a set of five European prestandards for messages. This document is aiming to provide such a set of components and has been developed jointly with a new European standard for Service Request and Report messages that is using the comp
35、onents defined herein. Another important background to the development of this European Standard has been the wish for a harmonisation of information models for health developed in Europe and the USA expressed in the collaboration agreement entered March 2000 between CEN/TC 251 and HL7 (Health Level
36、 Seven, Ann Arbor. Michigan). The goal was set for a maximum degree of alignment while maintaining their independence and need to serve the business requirements of the respective markets but also to make the results available to ISO for possible international standardization. HL7 have adapted a gen
37、eral strategy similar to CEN/TC 251 using information modelling2expressed in UML (Unified Modeling Language) for their new standards and a lot of interaction and information sharing has occurred between CEN experts and HL7 in an open spirit of collaboration. This European Standard includes a large n
38、umber of objects which are technically identical to descriptions in draft documents of HL7, although partly described differently due to the fact that CEN is following the ISO rules for drafting and presentation of standards which HL7 is not. CEN wishes to express its gratitude towards HL7 experts f
39、or generously sharing their models with the European expert team. This European Standard contains definition of a set of clinical general purpose information components. Many aspects of this document require explanation which is provided in EN 14822-1. 1See Annex A: Rationale for this document on Ge
40、neral Purpose Information Components. 2Modelling is British English spelling whereas Modeling is US English spelling. B55EB1B3E14C22109E918E8EA43EDB30F09CC9B7EF8DD9NormCD - Stand 2007-03 EN 14822-3:2005 (E) 6 1 Scope This European Standard specifies the definition and structuring of information rela
41、ting to entities that are commonly encountered in communications with and between clinical information computer systems. Within the scope of this European Standard is a description of components and their use. In particular, these components relate to the following sub-domains: Analysable objects: i
42、ncluding samples, body parts, x-rays and other study products, together with their collection and properties. Clinical information: including observations, patient conditions, procedures, medication treatment, investigations, counselling plus how these items are organised within a record. Medicinal
43、products: including appliances, dosage regimes,etc. Routing aspects of medication treatment or other procedures. Care Service information: including referrals for care services, care encounter information and scheduling. 2 Normative references Not applicable. 3 Terms and definitions For the purposes
44、 of this European Standard, the following terms and definitions apply. 3.1 analysable object something derived from or to be derived from a patient as part of a diagnostic or laboratory investigation ENV 12539:1997 - revised NOTE 1 Analysed object is a generalisation that includes samples taken from
45、 a patient and physical or digital records of information derived from a patient as part of a diagnostic service. An analysed object that is not a sample is referred to as a study product. NOTE 2 An analysed object need not exist in a tangible form but may represent something observed briefly by a d
46、iagnostic service provider. EXAMPLE 1 An x-ray image, a series of x-ray images, part of an x-ray image. The image may exist in a digitised form or as a film. EXAMPLE 2 An electrocardiograph (ECG) monitor tracing or a twelve lead ECG. EXAMPLE 3 An organ removed during surgery or post-mortem, a biopsy,
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