1、DEUTSCHE NORM Juli 2003Medizinische InformatikSchnittstellen zwischen klinischen Analysegerten undLaborinformationssystemenBenutzerprofile (ISO 18812:2003)Deutsche Fassung EN ISO 18812:2003, Text EnglischEN ISO 18812ICS 35.240.80Ersatz frDIN V ENV 13728:2000-11Health informatics Clinical analyser in
2、terfaces to laboratory information systems Use profiles (ISO 18812:2003);English version EN ISO 18812:2003Informatique de sant Interfaces danalyseur clinique pour systmes dinformation de laboratoire Profils dutilisation (ISO 18812:2003);Version anglaise EN ISO 18812:2003Die Europische Norm EN ISO 18
3、812:2003 hat den Status einer Deutschen Norm.Nationales VorwortDiese Norm enthlt unter Bercksichtigung des Prsidialbeschlusses 13/1983 den englischen Originaltextder Internationalen Norm ISO 18812, Ausgabe 2003-03. Die Europische Vornorm wurde in der WG IVTechnology for Interoperability des CEN/TC 2
4、51 Medizinische Informatik erarbeitet und von der WG 2Messaging and Communication des ISO/TC 215 Health Informatics berarbeitet. Der ArbeitsausschussG 2 Kommunikation des Fachbereichs G Medizinische Informatik des Normenausschusses Medizin imDIN hat an der Erarbeitung mitgewirkt.nderungenGegenber DI
5、N V ENV 13728:2000-11 wurden folgende nderungen vorgenommen: Die Norm ist vom technischen und inhaltlichen Aufbau identisch mit der DIN V ENV 13728, die imNovember 2000 publiziert wurde. Die Normativen Verweisungen wurden berarbeitet.Frhere AusgabenDIN V ENV 13728: 2000-11Fortsetzung 58 Seiten ENNor
6、menausschuss Medizin (NAMed) im DIN Deutsches Institut fr Normung e. V. DIN Deutsches Institut fr Normung e.V. .Jede Art der Vervielfltigung, auch auszugsweise, Ref. Nr. DIN EN ISO 18812:2003-07nur mit Genehmigung des DIN Deutsches Institut fr Normung e. V., Berlin, gestattet. Preisgr. 20 Vertr.-Nr.
7、 2320Alleinverkauf der Normen durch Beuth Verlag GmbH, 10772 BerlinB55EB1B3E14C22109E918E8EA43EDB30F09CC9B7EF8DD9NormCD - Stand 2007-03 Leerseite B55EB1B3E14C22109E918E8EA43EDB30F09CC9B7EF8DD9NormCD - Stand 2007-03 EUROPISCHE NORMEUROPEAN STANDARDNORME EUROPENNEEN ISO 18812Mrz 2003ICS 35.240.80 Ersa
8、tz fr ENV 13728:2000Deutsche FassungMedizinische InformatikSchnittstellen zwischen klinischen Analysegerten undLaborinformationssystemenBenutzerprofile(ISO 18812:2003)Health informaticsClinical analyser interfaces to laboratory informationsystemsUse profiles(ISO 18812:2003)Informatique de santInterf
9、aces danalyseur clinique pour systmes dinformationde laboratoireProfils dutilisation(ISO 18812:2003)Diese Europische Norm wurde vom CEN am 11. Mrz 2003 angenommen.Die CEN-Mitglieder sind gehalten, die CEN/CENELEC-Geschftsordnung zu erfllen, in der die Bedingungen festgelegt sind, unter denendieser E
10、uropischen Norm ohne jede nderung der Status einer nationalen Norm zu geben ist. Auf dem letzten Stand befindliche Listendieser nationalen Normen mit ihren bibliographischen Angaben sind beim Management-Zentrum oder bei jedem CEN-Mitglied auf Anfrageerhltlich.Diese Europische Norm besteht in drei of
11、fiziellen Fassungen (Deutsch, Englisch, Franzsisch). Eine Fassung in einer anderen Sprache,die von 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-M
12、itglieder sind die nationalen Normungsinstitute von Belgien, Dnemark, Deutschland, Finnland, Frankreich, Griechenland, Irland,Island, Italien, Luxemburg, Malta, Niederlande, Norwegen, sterreich, Portugal, Schweden, Schweiz, Slowakei, Spanien, derTschechischen Republik, Ungarn und dem Vereinigten Kni
13、greich.EUROPISCHES KOMITEE FR NORMUNGEUROPEAN COMMITTEE FOR STANDARDIZATIONCOMIT EUROPEN DE NORMALISATIONManagement-Zentrum: rue de Stassart, 36 B-1050 Brssel 2003 CEN Alle Rechte der Verwertung, gleich in welcher Form und in welchemVerfahren, sind weltweit den nationalen Mitgliedern von CEN vorbeha
14、lten.Ref. Nr. EN ISO 18812:2003 DB55EB1B3E14C22109E918E8EA43EDB30F09CC9B7EF8DD9NormCD - Stand 2007-03 EN ISO 18812:2003 (E)2VorwortDieses Dokument (EN ISO 18812:2003) wurde vom Technischen Komitee ISO/TC 215 Health Informatics inZusammenarbeit mit dem Technischen Komitee CEN/TC 251 Health Informatic
15、s, dessen Sekretariat vomSIS gehalten wird, erarbeitet.Diese Europische Norm muss den Status einer nationalen Norm erhalten, entweder durch Verffentlichungeines identischen Textes oder durch Anerkennung bis September 2003, und etwaige entgegenstehendenationale Normen mssen bis September 2003 zurckge
16、zogen werden.Dieses Dokument ersetzt ENV 13728:2000.Entsprechend der CEN/CENELEC-Geschftsordnung sind die nationalen Normungsinstitute der folgendeLnder gehalten, diese Europische Norm zu bernehmen: Belgien, Dnemark, Deutschland, Finnland,Frankreich, Griechenland, Irland, Island, Italien, Luxemburg,
17、 Malta, die Niederlande, Norwegen, sterreich,Portugal, Schweden, die Schweiz, die Slowakei, Spanien, die Tschechische Republik, Ungarn und dasVereinigte Knigreich.B55EB1B3E14C22109E918E8EA43EDB30F09CC9B7EF8DD9NormCD - Stand 2007-03 EN ISO 18812:2003 (E)3ContentsPageVorwort 2Foreword. 4Introduction 5
18、1 Scope . 72 Normative references . 73 Terms and definitions. 74 Domains. 94.1 User domain 94.2 Interface domain . 95 Conformity. 106 Profiles. 106.1 General. 106.2 Message descriptions 106.3 Profile descriptions 116.4 Sequence diagrams 116.5 Attribute optionality and allowed values 13Annex A (infor
19、mative) How to read this International Standard 17Annex B (informative) Scenarios and models. 20Annex C (informative) Implementation guidelines 37Bibliography . 58B55EB1B3E14C22109E918E8EA43EDB30F09CC9B7EF8DD9NormCD - Stand 2007-03 EN ISO 18812:2003 (E)4ForewordISO (the International Organization fo
20、r Standardization) is a worldwide federation of national standards bodies(ISO member bodies). The work of preparing International Standards is normally carried out through ISOtechnical committees. Each member body interested in a subject for which a technical committee has beenestablished has the ri
21、ght to be represented on that committee. International organizations, governmental andnon-governmental, in liaison with ISO, also take part in the work. ISO collaborates closely with theInternational Electrotechnical Commission (IEC) on all matters of electrotechnical standardization.International S
22、tandards are drafted in accordance with the rules given in the ISO/IEC Directives, Part 2.The main task of technical committees is to prepare International Standards. Draft International Standardsadopted by the technical committees are circulated to the member bodies for voting. Publication as anInt
23、ernational Standard requires approval by at least 75 % of the member bodies casting a vote.Attention is drawn to the possibility that some of the elements of this document may be the subject of patentrights. ISO shall not be held responsible for identifying any or all such patent rights.ISO 18812 wa
24、s prepared by Technical Committee ISO/TC 215, Health informatics.B55EB1B3E14C22109E918E8EA43EDB30F09CC9B7EF8DD9NormCD - Stand 2007-03 EN ISO 18812:2003 (E)5IntroductionThis International Standard describes messages for the transfer of data between analytical instruments (AIs)and laboratory informati
25、on systems (LISs).AIs are mainly used in hospital laboratories to analyse samples from patients. Most of these are interfaced toLISs that process the result data and produce reports for use by healthcare practitioners. In the absence ofstandards for the interface, each LIS supplier has to write a ne
26、w interface for each new analytical instrument.The cost of writing these interfaces can amount to between 10 % and 20 % of the total cost of the LIS. One ofthe most effective ways of reducing this cost is to implement a standard interface between the AI and the LIS.In the early 1990s, the E31 commit
27、tee of the American Society for Testing and Materials (ASTM) published astandard entitled Standard Specification for Transferring Information Between Clinical Instruments andComputer Systems (ASTM E1394-91). This improved the situation by standardizing the format of themessage and the syntax. It als
28、o attempted to standardize the data transferred in the messages, but sufferedfrom implementation problems because: the vast choice of data items available gave implementers the choice to send the same data in manydifferent ways; the relative lack of implementation guidelines meant that different imp
29、lementers interpreted the sameclauses of the standard in different ways; much of the information that is defined in the standard is intended for use in North America and does notcover international requirements.The result of this is that each AI supplier has produced its own standard, based loosely
30、on ASTM E1394.Whereas this has made interfacing easier for the analytical instrument suppliers, the LIS suppliers are stillfaced with the need to write a different interface for most of the analytical instruments installed in a givenlaboratory.In particular, the LIS interface designer has to, in the
31、ory, take into account any implementation allowed byASTM E1394. This means that even simple AIs are normally handled by using a hugely complex interface onthe LIS.ASTM E1394-91 was reissued with minor revisions in 1997 as ASTM E1394-97.This International Standard is intended to make interfaces betwe
32、en AIs and LISs simpler to implement by defining standard ways of conveying the same information in the same circumstances; defining a series of levels of complexity so that it is possible to interface a simple AI using only easy-to-implement messages; adapting the original standard to cover actual
33、requirements; giving advice and guidance on how particular data items and functions should be implemented so as toreduce misinterpretation.This is done by defining a series of standard messages, each of which is a subset of a comparableASTM E1394 message. These are detailed in Clause 6. Examples of
34、scenarios covered by this InternationalStandard, together with models and sequence diagrams, are given in Annex B. An informative implementationguide for both ASTM E1394 and this International Standard is given in Annex C.B55EB1B3E14C22109E918E8EA43EDB30F09CC9B7EF8DD9NormCD - Stand 2007-03 EN ISO 18
35、812:2003 (E)6There is a trend for all clinical laboratories to be certified or accredited under a suitable quality managementscheme. ISO/IEC 17025 require the laboratory to keep records of certain data. This means that, for thesupport of the users when conforming to the standard, the instruments and
36、 LIS have to be capable of handlingthis data (input, storage, validation, output), and also of transmitting it. This is especially important in functionsthat produce large amounts of data that cannot be handled effectively without automated processing.Typically, this is a task for the LIS, but certa
37、in items have to originally come from the instrument. ASTM E1394does not explicitly handle data needed for quality management. In principle, it is capable of doing so, but theneeded fields have to be defined.This has been achieved in this International Standard by making recommendations as to which
38、fields shall beimplemented in order to satisfy the needs of quality management. These are identified in the implementationguideline included as Annex C.This International Standard includes provisions for using existing ASTM E1394 records and fields to meetquality management requirements.This Interna
39、tional Standard defines records that are subsets of records defined in ASTM E1394. Therefore, allimplementations conforming to this International Standard also conform to ASTM E1394. It should be noted,however, that not all implementations that conform to ASTM E1394 will conform to this Internationa
40、l Standard.Those not familiar with some of the concepts, e.g. profiling, described here should first refer to Annex A.B55EB1B3E14C22109E918E8EA43EDB30F09CC9B7EF8DD9NormCD - Stand 2007-03 EN ISO 18812:2003 (E)71 ScopeThis International Standard specifies general messages for electronic information ex
41、change betweenanalytical instruments (AIs) and laboratory information systems (LISs) within a clinical laboratory. It isapplicable to the specialities of clinical chemistry/biochemistry, haematology, toxicology, microbiology, virologyand immunology. It is not applicable to the blood transfusion and
42、blood bank specialityThis International Standard covers the specification of messages used by communicating parties and thesyntax in which they are communicated. It does not cover the transport mechanisms used for the messageinterchange.This International Standard is applicable only to character-bas
43、ed message information. It is not applicable tothe communication of graphical or image information.NOTE The provisions for this International Standard have been validated in the domains and for the purposesdescribed above. However, messages conforming to this International Standard may be considered
44、 by some usercommunities to meet their needs for purposes outside this scope. Use of the messages in these circumstances is notprecluded by the scope.2 Normative referencesThe following referenced documents are indispensable for the application of this document. For datedreferences, only the edition
45、 cited applies. For undated references, the latest edition of the referenceddocument (including any amendments) applies.ASTM E1394-971), Standard Specification for Transferring Information between Clinical Instruments andComputer Systems3 Terms and definitionsFor the purposes of this document, the following terms and definitions apply.3.1analytecomponent indicated in the name of a measurable quantity3.2analytical instrumentAIna
