EN ISO 11073-10418-2014 en Health informatics - Personal health device communication - Part 10418 Device specialization - International Normalized Ratio (INR) monitor《健康信息学 个人保健装置通.pdf

1、BSI Standards PublicationBS EN ISO 11073-10418:2014Health informatics Personalhealth device communicationPart 10418: Device specialization International Normalized Ratio (INR)monitorBS EN ISO 11073-10418:2014Incorporating corrigendum June 2014BS EN ISO 11073-10418:2014 BRITISH STANDARDNational forew

2、ordThis British Standard is the UK implementation of EN ISO 11073-10418:2014. It is identical to ISO/IEEE 11073-10418:2014.The UK participation in its preparation was entrusted to Technical Committee IST/35, Health informatics.A list of organizations represented on this committee can be obtained on

3、request to its secretary.This publication does not purport to include all the necessary provisions of a contract. Users are responsible for its correct application. The British Standards Institution 2014. Published by BSI Standards Limited 2014ISBN 978 0 580 86985 3ICS 35.240.80Compliance with a Bri

4、tish Standard cannot confer immunity from legal obligations.This British Standard was published under the authority of the Standards Policy and Strategy Committee on 31 March 2014.Amendments/corrigenda issued since publicationDate Text affected30 June 2014 CEN correction notice 21 May 2014 implement

5、s ISO/IEEE corrected text 01 May 2014, which removes IEEE licensing text from footersEUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN ISO 11073-10418 March 2014 ICS 35.240.80 English Version Health informatics - Personal health device communication - Part 10418: Device specialization - Internati

6、onal Normalized Ratio (INR) monitor (ISO/IEEE 11073-10418:2014, Corrected version 2014-05-01) Informatique de sant - Communication entre dispositifs mdicaux sur le site des soins - Partie 10418: Spcialisation des dispositifs - Surveillance du rapport normalis international (INR) (ISO/IEEE 11073-1041

7、8:2014,Version corrige 2014-05-01) Medizinische Informatik - Kommunikation von Gerten fr die persnliche Gesundheit - Teil 10418: Gertespezifikation - Monitor fr den international standardisierter Thromboplastinzeit-Quotient (INR) (ISO/IEEE 11073-10418:2014, korrigierte Fassung 2014-05-01) This Europ

8、ean Standard was approved by CEN on 14 December 2013. CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this European Standard the status of a national standard without any alteration. Up-to-date lists and bibliographical references c

9、oncerning such national standards may be obtained on application to the CEN-CENELEC Management Centre or to any CEN member. This European Standard exists in three official versions (English, French, German). A version in any other language made by translation under the responsibility of a CEN member

10、 into its own language and notified to the CEN-CENELEC Management Centre has the same status as the official versions. CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, Former Yugoslav Republic of Macedonia, Franc

11、e, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and United Kingdom. EUROPEAN COMMITTEE FOR STANDARDIZATION COMIT EUROPEN DE NORMALISATION EUROPISCHES KOM

12、ITEE FR NORMUNG CEN-CENELEC Management Centre: Avenue Marnix 17, B-1000 Brussels 2014 CEN All rights of exploitation in any form and by any means reserved worldwide for CEN national Members. Ref. No. EN ISO 11073-10418:2014 EEN ISO 11073-10418:2014 (E) 3 Foreword This document (EN ISO 11073-10418:20

13、14) has been prepared by Technical Committee ISO/TC 215 “Health informatics” in collaboration with Technical Committee CEN/TC 251 “Health informatics” 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 identic

14、al text or by endorsement, at the latest by September 2014, and conflicting national standards shall be withdrawn at the latest by September 2014. Attention is drawn to the possibility that some of the elements of this document may be the subject of patent rights. CEN and/or CENELEC shall not be hel

15、d responsible for identifying any or all such patent rights. According to the CEN-CENELEC Internal Regulations, the national standards organizations of the following countries are bound to implement this European Standard: Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia

16、, Finland, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the United Kingdom. Endorsement notice The tex

17、t of ISO/IEEE 11073-10418:2014, Corrected version 2014-05-01 has been approved by CEN as EN ISO 11073-10418:2014 without any modification. BS EN ISO 11073-10418:2014EN ISO 11073-10418:2014 (E)ISO/IEEE 11073-10418:2014(E) IEEE 2011 All rights reserved iiiForeword ISO (the International Organization f

18、or Standardization) is a worldwide federation of national standards bodies (ISO member bodies). The work of preparing International Standards is normally carried out through ISO technical committees. Each member body interested in a subject for which a technical committee has been established has th

19、e right to be represented on that committee. International organizations, governmental and non-governmental, in liaison with ISO, also take part in the work. ISO collaborates closely with the International Electrotechnical Commission (IEC) on all matters of electrotechnical standardization. IEEE Sta

20、ndards documents are developed within the IEEE Societies and the Standards Coordinating Committees of the IEEE Standards Association (IEEE-SA) Standards Board. The IEEE develops its standards through a consensus development process, approved by the American National Standards Institute, which brings

21、 together volunteers representing varied viewpoints and interests to achieve the final product. Volunteers are not necessarily members of the Institute and serve without compensation. While the IEEE administers the process and establishes rules to promote fairness in the consensus development proces

22、s, the IEEE does not independently evaluate, test, or verify the accuracy of any of the information contained in its standards. The main task of technical committees is to prepare International Standards. Draft International Standards adopted by the technical committees are circulated to the member

23、bodies for voting. Publication as an International Standard requires approval by at least 75 % of the member bodies casting a vote. Attention is called to the possibility that implementation of this standard may require the use of subject matter covered by patent rights. By publication of this stand

24、ard, no position is taken with respect to the existence or validity of any patent rights in connection therewith. ISO/IEEE is not responsible for identifying essential patents or patent claims for which a license may be required, for conducting inquiries into the legal validity or scope of patents o

25、r patent claims or determining whether any licensing terms or conditions provided in connection with submission of a Letter of Assurance or a Patent Statement and Licensing Declaration Form, if any, or in any licensing agreements are reasonable or non-discriminatory. Users of this standard are expre

26、ssly advised that determination of the validity of any patent rights, and the risk of infringement of such rights, is entirely their own responsibility. Further information may be obtained from ISO or the IEEE Standards Association. ISO/IEEE 11073-10418 was prepared by the Substations Committee of t

27、he IEEE Power Engineering Society of the IEEE (as IEEE 11073-10418-2011). It was adopted by Technical Committee ISO/TC 215, Respiratory and anaesthetic equipment, in parallel with its approval by the ISO member bodies, under the “fast-track procedure” defined in the Partner Standards Development Org

28、anization cooperation agreement between ISO and IEEE. IEEE is responsible for the maintenance of this document with participation and input from ISO member bodies. ISO/IEEE 11073 consists of the following parts, under the general title Health informatics Personal health device communication (text in

29、 parentheses gives a variant of subtitle): Part 00103: Overview Part 10101: (Point-of-care medical device communication) Nomenclature Part 10102: (Point-of-care medical device communication) Nomenclature Annotated ECG Part 10103: (Point-of-care medical device communication) Nomenclature Implantable

30、device, cardiac Part 10201: (Point-of-care medical device communication) Domain information model Part 10404: Device specialization Pulse oximeter BS EN ISO 11073-10418:2014ISO/IEEE 11073-10418:2014(E)ISO/IEEE 11073-10418:2014(E) iv IEEE 2011 All rights reserved Part 10406: Device specialization Bas

31、ic electrocardiograph (ECG) (1- to 3-lead ECG) Part 10407: Device specialization Blood pressure monitor Part 10408: Device specialization Thermometer Part 10415: Device specialization Weighing scale Part 10417: Device specialization Glucose meter Part 10418: Device specialization International Norma

32、lized Ratio (INR) monitor Part 10420: Device specialization Body composition analyzer Part 10421: Device specialization Peak expiratory flow monitor (peak flow) Part 10441: Device specialization Cardiovascular fitness and activity monitor Part 10471: Device specialization Independant living activity

33、 hub Part 10472: Device specialization Medication monitor Part 20101: (Point-of-care medical device communication) Application profiles Base standard Part 20601: Application profile Optimized exchange protocol Part 30200: (Point-of-care medical device communication) Transport profile Cable connected

34、 Part 30300: (Point-of-care medical device communication) Transport profile Infrared wireless Part 30400: (Point-of-care medical device communication) Interface profile Cabled Ethernet Part 90101: (Point-of-care medical device communication) Analytical instruments Point-of-care test Part 91064: (Sta

35、ndard communication protocol) Computer-assisted electrocardiography Part 92001: (Medical waveform format) Encoding rules This corrected version of ISO 11073-10417:2014 incorporates the following correction: the text “Authorized licensed use limited to: IEEE Standards Staff and authorized IEEE Sponso

36、r Ballot Participants. Downloaded on May 28,2013 at 14:27:23 UTC from IEEE Xplore. Restrictions apply.“ has been deleted from the footer. g3g3g3Part 10418: Device specialization International Normalized Ratio (INR) monitor g3Sponsored by the IEEE 11073 Standards Committee g3IEEE 3 Park Avenue New Yo

37、rk, NY 10016-5997 USA 9 November 2011 IEEE Engineering in Medicine and Biology Society IEEE Std 11073-10418g4862011Health informaticsPersonal health device communication BS EN ISO 11073-10418:2014ISO/IEEE 11073-10418:2014(E)g3g3g3Part 10418: Device specialization International Normalized Ratio (INR)

38、 monitor g3Sponsored by the IEEE 11073 Standards Committee g3IEEE 3 Park Avenue New York, NY 10016-5997 USA 9 November 2011 IEEE Engineering in Medicine and Biology Society IEEE Std 11073-10418g4862011Health informaticsPersonal health device communication BS EN ISO 11073-10418:2014,(6WG70+HDOWKLQIRU

39、PDWLFV3HUVRQDOKHDOWKGHYLFHFRPPXQLFDWLRQ3DUWHYLFHVSHFLDOLDWLRQ,QWHUQDWLRQDO1RUPDOLHG5DWLR ,15 PRQLWRU6SRQVRU,(706WDQGDUGV and the Results (action-info-args) column defines the structure to use in the action-info-args of the response. Table 2 MDS object methods Service Subservice type nameMode Subserv

40、ice type (action-type)Parameters(action-info-args)Results (action-info-args)ACTION Set-Base-Offset-Time Confirmed MDC_ACT_SET_BO_TIME SetBOTimeInvoke Set-Base-Offset-Time This method allows the manager to set a real-time clock in the agent with the base time and offset. The agent indicates whether t

41、he Set-Base-Offset-Time command is valid using the mds-time-capab-set-clock bit in the Mds-Time-Info attribute (see IEEE Std 11073-20601a-2010).If the agent supports the Base-Offset-Time-Stamp attribute, this method shall be implemented. Agents following only this device specialization and no others

42、 shall send event reports using agent-initiated measurement data transmission. Agents following this device specialization as well as others shall send event reports in the appropriate fashion. During the association procedure (see 8.3), data-req-mode-capab shall be set to the appropriate value for

43、the event report style. As a result, the manager shall assume the INR monitor agent does not support any of the MDS-Data-Request features (see IEEE Std 11073-20601a-2010 for additional information). Thus, implementation of the MDS-Data-Request method/action is not required in this standard and is no

44、t shown in Table 2. 6.5.3 MDS object events Table 3 defines the events that can be sent by the INR monitor MDS object. Table 3 INR monitor MDS object events Service Subservice type nameMode Subservice type (event-type)Parameters(event-info)Results (event-reply-info)EVENTREPORT MDS-Configuration-Even

45、t Confirmed MDC_NOTI_CONFIG ConfigReport ConfigReportRsp MDS-Dynamic-Data-Update-Var Confirmed MDC_NOTI_SCAN_ REPORT_VAR ScanReportInfoVar MDS-Dynamic-Data-Update-Fixed Confirmed MDC_NOTI_SCAN_ REPORT_FIXED ScanReportInfoFixed MDS-Dynamic-Data-Update-MP-Var Confirmed MDC_NOTI_SCAN_ REPORT_MP_VAR Sca

46、nReportInfoMPVar MDS-Dynamic-Data-Update-MP-Fixed Confirmed MDC_NOTI_SCAN_ REPORT_MP_FIXED ScanReportInfoMPFixed ,62,( ( IEEE Std 11073-10418-2011 Health informaticsPersonal health device communication Part 10418: Device specializationInternational Normalized Ratio (INR) monitor 13 Copyright 2011 IE

47、EE. All rights reserved.MDS-Configuration-Event:This event is sent by the INR monitor agent during the configuring procedure if the manager does not already know the INR monitor agents configuration from past associations or because the manager has not been implemented to recognize the configuration

48、 according to the INR monitor device specialization. The event provides static information about the supported measurement capabilities of the INR monitor agent.MDS-Dynamic-Data-Update-Var:This event provides dynamic measurement data from the INR monitor agent numeric and enumeration object(s). These data are reported using a generic attribute list variable format. The event is sent as an unsolicited message by the a