1、DRAFT FOR DEVELOPMENT DD ENV 13735:2001 Health informatics Interoperability of patient connected medical devices ICS 35.240.80 NO COPYING WITHOUT BSI PERMISSION EXCEPT AS PERMITTED BY COPYRIGHT LAWDD ENV 13735:20001 This Draft for Development, having been prepared under the direction of the DISC boa
2、rd, was published under the authority of the Standards Policy and Strategy Committee on 19 October 2001 BSI 19 October 2001 ISBN 0 580 38594 9 National foreword This Draft for Development is the English language version of ENV 13735:2001. This publication is not to be regarded as a British Standard.
3、 It is being issued in the Draft for Development series of publications and is of a provisional nature due to the limited duration of the European Prestandard. It should be applied on this provisional basis, so that information and experience of its practical application may be obtained. Comments ar
4、ising from the use if this Draft for Development are requested so that UK experience can be reported to the European organization responsible for its conversion into a European Standard. A review of this publication will be initiated 2 years after its publication by the European organization so that
5、 a decision can be taken on its status at the end of its three-year life. The commencement of the review period will be notified by an announcement in Update Standards. According to the replies received by the end of the review period, the responsible BSI Committee will decide whether to support the
6、 conversion into a European Standard, to extend the life of the prestandard or to withdraw it. Comments should be sent in writing to the Secretary of BSI Technical Committee IST/35, Health Informatics, at 389 Chiswick High Road, London W4 4AL, giving the document reference and clause number and prop
7、osing, where possible, an appropriate revision of the text. A list of organizations represented on this committee can be obtained on request to its secretary. Cross-references The British Standards which implement international or European publications referred to in this document may be found in th
8、e BSI Standards Catalogue under the section entitled “International Standards Correspondence Index”, or by using the “Find” facility of the BSI Standards Electronic Catalogue. Summary of pages This document comprises a front cover, an inside front cover, the ENV title page, pages 2 to 175 and a back
9、 cover. The BSI copyright date displayed in this document indicates when the document was last issued. Amendments issued since publication Amd. No. Date CommentsEUROPEANPRESTANDARD PRNORMEEUROPENNE EUROPISCHEVORNORM ENV13735 September2000 ICS35.240.80 Englishversion HealthinformaticsInteroperability
10、ofpatientconnectedmedical devices ThisEuropeanPrestandard(ENV)wasapprovedbyCENon7January2000asaprospectivestandardforprovisionalapplication. TheperiodofvalidityofthisENVislimitedinitiallytothreeyears.AftertwoyearsthemembersofCENwillberequestedto submittheir comments,particularlyonthequestionwhethert
11、heENVcanbeconvertedintoaEuropeanStandard. CENmembersarerequiredtoannouncetheexistenceofthisENVinthesamewayasforanENandtomaketheENVavailablepromp tly atnationallevelinanappropriateform.Itispermissibletokeepconflictingnationalstandardsinforce(inparalleltothe ENV)untilthefinal decisionaboutthepossiblec
12、onversionoftheENVintoanENisreached. CENmembersarethenationalstandardsbodiesofAustria,Belgium,CzechRepublic,Denmark,Finland,France,Germany,Greece, Iceland,Ireland,Italy,Luxembourg,Netherlands,Norway,Portugal,Spain,Sweden,SwitzerlandandUnitedKingdom. EUROPEANCOMMITTEEFORSTANDARDIZATION COMITEUROPENDEN
13、ORMALISATION EUROPISCHESKOMITEEFRNORMUNG CentralSecretariat:ruedeStassart,36B1050Brussels 2000CEN Allrightsofexploitationinanyformandbyanymeansreserved worldwideforCENnationalMembers. Ref.No.ENV13735:2000EPage2 ENV13735:2000 Contents Foreword. 4 Introduction 5 1 Scope. 6 2 Normativereference(s) 6 3
14、Term(s)anddefinition(s) . 6 4 Symbols(andabbreviatedterms) 11 5 Requirements . 13 6 Models . 14 6.1 DomainInformationModelfortheCommunicationSubject . 14 6.2 ObjectDefinitions .16 6.3 DynamicModel .24 7 Messages 30 7.1 General. 30 7.2 ACSEProtocol. .31 7.3 SessionLayerProtocol . 31 7.4 PresentationL
15、ayerProtocol . 31 7.5 ROSEProtocol. .32 7.6 CMDISEProtocol(CMDIP). 32 8 Encodingrules . 3 3 8.1 Overview . 33 8.2 MedicalDataEncodingRules(MDER). 34 8.3 AbstractSyntax. .34 8.4 TransferSyntax . .34 9 ApplicationProfiles 35 9.1 General 35 9.2 BaselineApplicationProfile 36 9.3 PollingModeApplicationPr
16、ofile 53 9.4 Conformance 61Page3 ENV13735:2000 9.5 ImplementationConformanceStatements 61 AnnexA (informative) ExampleOptionalPackages . 67 AnnexB (normative) NomenclatureExtensions. 70 AnnexC (informative) ACSEUserInfoField . 78 AnnexD (normative) IEEE1073SpecificMIBElementObjectDefinitions 80 Anne
17、xE (informative) RequirementsandScenarios 84 AnnexF (Informative) MappingbetweenScenarios,DeviceTypesandApplicationProfiles . 101 AnnexG (normative) StateTransitionTables . 171Page4 ENV13735:2000 Foreword ThisEuropeanPrestandardhasbeenpreparedbyTechnicalCommitteeCEN/TC251“Health informatics“,thesecr
18、etariatofwhichisheldbySIS. AccordingtotheCEN/CENELECInternalRegulations,thenationalstandardsorganizationsofthe followingcountriesareboundtoannouncethisEuropeanPrestandard:Austria,Belgium,Czech Republic,Denmark,Finland,France,Germany,Greece,Iceland,Ireland,Italy,Luxembourg, Netherlands,Norway,Portuga
19、l,Spain,Sweden,SwitzerlandandtheUnitedKingdom.Page5 ENV13735:2000 Introduction Medicaltechnologyhasdevelopedinthecontextofrapidadvancesinthescienceofinformation technologyandhasbenefitedgreatlybyincorporatingtheseadvancesintomanymedicaldevices. Thishasbeendoneinarelativelyunstructuredmannerwithmanyd
20、evicesbeingdevelopedin isolationandinawaythatprecludescommunicationbothbetweenthemselvesandwithhospital computeranddatamanagementsystems.Thosedevicesthatcancommunicategenerallyusea proprietarycommunicationprotocol,whichprecludesconnectiontodevicesfromdifferent manufacturers. Thepotentialadvantagesof
21、suchcommunicationarebecomingmoreandmoreobvious. Consequently,thereisapressingneedfortechnicalstandardisationandthedevelopmentofservices andprotocolstoenablesuchcommunicationtoexistinaneasyandopenway,withsubsequent clinical,administrativeandresearchbenefits. Thefirststepstowardthedevelopmentofsuchast
22、andardwereinitiatedbyIEEEgroupp1073in 1984developingwhathasbecomeknowastheMedicalInformationBus(MIB).Thedevelopmentof thatsetofstandardshasfollowedtheISO/OSIlayersasdemonstratedinthefollowingfigure: ManagerApplicationProcess(es) AgentApplicationProcess(es) CMDISE CMDISE A C S E A C S E PresentationL
23、ayer PresentationLayer SessionLayer SessionLayer TransportSystem TransportSystem MDIB MDIB MDS VMD Channel NU RT SA AL Channel NU AL . Figure1.ExampleofagentmanagercommunicationsystemfollowingISO/OSIprincipals. AnessentialelementwasthedevelopmentofastandardforVitalSignsInformationRepresentation, whi
24、chcoveredtheobjectsandattributescollectivelyknownastheMDIB(areashadedinfig1).This workhasnowbeendone(ENV13734).Thenextstage,whichisthefocusofthisproject,isthe developmentofnecessaryservicesandprotocols,basedonISO/OSIstandards,whichenabletrue interoperabilitybetweenmedicaldevices.Thesecovertheareasin
25、thefiguremarkedasACSE, CMDISE,presentationlayerandsessionlayer.Interoperabilityofmedicaldevicesraisesmany technical,safety,andlegalissues,whichareworthyofconsideration.TheongoingworkoftheIEEE standardsgroupIEEE1073hasbeentakenintoconsiderationandreferenceismadeparticularlyto theirproposedstandard107
26、3.2.0MedicalDeviceApplicationProfile(MDAP).Page6 ENV13735:2000 Theprimaryuserofthisstandardisasoftwareengineerwhoisdevelopinginterfacesoftwarefor medicaldevicescoveredinthescope.Thisisoneofanumberofstandardsthattheengineershould befamiliarwith,includingthefollowing: ISOopensystemsinterconnection(OSI
27、)layeredarchitecture. IEEE1073.1MIBframeworkandoverview. CENENV13734“VitalSignsInformationRepresentation” 1 Scope ThisEuropeanstandardappliestopatientconnectedmedicaldevicesthatcancommunicatepatient relatedphysiologicaldatabetweendevicesandbetweenadeviceandacomputersystem.Examples ofapplicabledevice
28、saregiveninannexE. Thisstandardspecifiesacommunicationcontrollermodelthatshouldbeusedbyapplicabledevices. ThisstandardstatesapplicablereferencesorspecifiesprotocolsincludingtheACSE,ROSE, CMDISE,presentationandsessionlayerprotocolsthatshallbeusedbyapplicabledevices. Thisstandarddefinesapplicationprof
29、ilesthatshallbeusedbyapplicabledevices,andthatshallbe quotedbymanufacturerswhenclaimingconformancetothisstandard.Appropriateconformance statementtemplatesareprovided. 2 Normativereference(s) Thefollowingnormativedocumentscontainprovisionsthat,throughreferenceinthistext,constitute provisionsofthisCEN
30、Standard.Fordatedreferences,subsequentamendmentsto,orrevisionsof, anyofthesepublicationsdonotapply.However,partiestoagreementsbasedonthisCENStandard areencouragedtoinvestigatethepossibilityofapplyingthemostrecenteditionsofthenormative documentsindicatedbelow.Foranundatedreference,thelatesteditionoft
31、henormativedocument referredtowillapply. IEEE1073.2.0: StandardforMedicalDeviceCommunicationsMedicalDeviceApplicationProfile IEEE1073.3.1:1996 Standard for Medical Device Communications Transport Profile ConnectionMode IEEE1073.4.1:1996 Standard for Medical Device Communications Physical Layer Inter
32、face Cableconnected ENV13734:1999 VitalSignsInformationRepresentation(VITAL) ISO74981:1994 InformationTechnologyOpenSystemsInterconnectionBasicReference Model ISO8649: InformationtechnologyOpenSystemsInterconnectionServicedefinitionforthe AssociationControlServiceElement ISO8824:1990 Informationtech
33、nologyOpenSystemsInterconnectionSpecificationof AbstractSyntaxNotationOne(ASN.1). ISO8825 Information technology Open Systems Interconnection Specification of encoding rulesforAbstractSyntaxNotationOne(ASN.1). ISO9596 Information technology Open Systems Interconnection Common Management InformationP
34、rotocolSpecification 3 Term(s)anddefinition(s) 3.1 Agent: AMedicalDevicewhichprovidesdatainamanager/agentcommunicatingsystem. 3.2 Alarm: ASignalwhichindicatesabnormaleventsoccurringtothepatientorthedevicesystem.Page7 ENV13735:2000 3.3 Alert: Synonymforthecombinationofpatientrelatedphysiologicalalarm
35、s,technicalalarmsandequipment useradvisorysignals. 3.4 AlertMonitor: Objectrepresentingtheoutputofadeviceorsystemalarmprocessorandassuchtheoveralldevice orsystemalarmcondition. 3.5 AlertStatus: Objectrepresentingtheoutputofanalarmprocessthatconsidersallalarmconditionsinascopethat spansoneormoreobjec
36、ts. 3.6 Archival: Relatingtothestorageofdataoveraprolongedperiod. 3.7 AssociationControlServiceElement Methodusedtoestablishlogicalconnectionsbetweenmedicaldevicesystems. 3.8 Channel: Umbrellaobjectintheobjectmodelthatgroupstogetherphysiologicalmeasurementdataanddata derivedfromthesedata. 3.9 Class:
37、 Descriptionofoneormoreobjectswithauniformsetofattributesandservicesincludingadescription ofhowtocreatenewobjectsintheclass. 3.10 CommonMedicalDeviceInformationServiceElement WithassociatedprotocolprovidesservicesthatallowaccesstotheobjectinstancesintheMedical DataInformationBase. 3.11 Communication
38、Controller: PartofaMedicalDeviceSystemresponsibleforcommunications. 3.12 CommunicationParty: Actoroftheproblemdomainparticipatinginthecommunicationtherein. 3.13 CommunicationRole: Roleofapartyinacommunicationsituationdefiningthepartysbehaviourinthecommunication. Associatedwithacommunicationroleisase
39、tofserviceswhichthepartyprovidestootherparties. 3.14 DataFormat: Arrangementofdatainafileorstream. 3.15 DataLogger: Amedicaldevicewhichisfunctioninginitscapacityasadatastorageandarchivalsystem.Page8 ENV13735:2000 3.16 DataAgent: Asamedicaldeviceapatientdataacquisitionsystemwhichprovidestheacquiredda
40、taforother devices. 3.17 DataStructure: Mannerinwhichapplicationentitiesconstructthedatasetinformationresultingfromtheuseofan informationobject. 3.18 Dictionary: DescriptionofthecontentsoftheMedicalDataInformationBasecontainingvitalsignsinformation, deviceinformation,demographics,andotherelementsoft
41、heMDIB. 3.19 DiscreteParameter: Vitalsignsmeasurementthatcanbeexpressedasasinglenumericortextualvalue. 3.20 DomainInformationModel: Themodeldescribingcommonconceptsandrelationshipsforaproblemdomain. 3.21 Event: Anoteworthyoccurrencethathasalocationintimeandspace. 3.22 EventReport: Service(providedby
42、theCMDISE)toreportdatarelatingtoamanagedobjectinstance. 3.23 Framework: Astructureofprocessesandspecificationsdesignedtosupporttheaccomplishmentofaspecific task. 3.24 GraphicParameter: Vitalsignsmeasurementthatrequiresanumberofregularlysampleddatapointsinordertobe expressedproperly. 3.25 Hostsystem:
43、 Termusedasanabstractionofamedicalsystemtowhichmeasurementdevicesareattached. 3.26 InformationObjects: Provideanabstractdatamodelapplicabletothecommunicationofvitalsignsinformationandrelated patientdata.Theattributesofaninformationobjectdefinitiondescribeitsproperties.Eachinformation objectdefinitio
44、ndoesnotrepresentaspecificinstanceofrealworlddata,butratheraclassofdata whichsharethesameproperties. 3.27 Instance: Forexample:objectinstance,applicationinstance,informationserviceelementinstance,VMD instance,classinstance,operatinginstance 3.28 IntensiveCareUnit: Unitwithinahospitalinwhichcriticallyillpatientsaremanagedusingmultiplemodesofmonitoring andvitalsystemsupports.Page9 ENV13735:2000 3.29 InterchangeFormat: Therepresentationofthedataelementsandthestructureofthemessagecontainingthosedata elementswhileintransferbetweensystems.Theinterchangefo
