BS EN ISO 11073-10471-2011 Health Informatics Personal health device communication Device specialization Independent living activity hub《健康信息学 个人健康设备通信 装置专业化 独立存在活性中心》.pdf

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1、raising standards worldwideNO COPYING WITHOUT BSI PERMISSION EXCEPT AS PERMITTED BY COPYRIGHT LAWBSI Standards PublicationBS EN ISO 11073-10471:2011Health Informatics Personal health device communicationPart 10471: Device specialization Independent living activity hub (ISO/IEEE 11073-10471:2010)BS E

2、N ISO 11073-10471:2011 BRITISH STANDARDNational forewordThis British Standard is the UK implementation of EN ISO 11073-10471:2011. It is identical to ISO/IEEE 11073-10471:2010.The UK participation in its preparation was entrusted to Technical Committee IST/35, Health informatics.A list of organizati

3、ons represented on this committee can be obtained on 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. BSI 2011 ISBN 978 0 580 68054 0 ICS 35.240.80 Compliance with a British Standard c

4、annot confer immunity from legal obligations.This British Standard was published under the authority of the Standards Policy and Strategy Committee on 30 April 2011.Amendments issued since publicationDate Text affectedEUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN ISO 11073-10471 March 2011 IC

5、S 35.240.80 English Version Health Informatics - Personal health device communication - Part 10471: Device specialization - Independant living activity hub (ISO/IEEE 11073-10471:2010) Informatique de sant - Communication entre dispositifs de sant personnels - Partie 10471: Spcialisation des disposit

6、ifs - Concentrateur dactivit pour une vie autonome (ISO/IEEE 11073-10471:2010) Medizinische Informatik - Kommunikation von Gerten fr die persnliche Gesundheit - Teil 10471: Gertespezifikation - Schnittstellenkonzentrator und -umsetzer fr assistierende Systeme (ISO/IEEE 11073-10471:2010) This Europea

7、n Standard was approved by CEN on 23 April 2010. 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 concer

8、ning 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 into

9、 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, France, Germany, Greece, Hungary, Iceland, Irelan

10、d, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom. EUROPEAN COMMITTEE FOR STANDARDIZATION COMIT EUROPEN DE NORMALISATION EUROPISCHES KOMITEE FR NORMUNG Management Centre: Avenue Marnix 17,

11、 B-1000 Brussels 2011 CEN All rights of exploitation in any form and by any means reserved worldwide for CEN national Members. Ref. No. EN ISO 11073-10471:2011: EBS EN ISO 11073-10471:2011 EN ISO 11073-10471:2011 (E) 3 Foreword The text of ISO/IEEE 11073-10471:2010 has been prepared by Technical Com

12、mittee ISO/TC 215 “Health informatics” of the International Organization for Standardization (ISO) and has been taken over as EN ISO 11073-10471:2011 by 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

13、national standard, either by publication of an identical text or by endorsement, at the latest by September 2011, and conflicting national standards shall be withdrawn at the latest by September 2011. Attention is drawn to the possibility that some of the elements of this document may be the subject

14、 of patent rights. CEN and/or CENELEC shall not be held 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, Bulga

15、ria, Croatia, 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, Switzerland and the United Kingdom. Endorsement notice

16、The text of ISO/IEEE 11073-10471:2010 has been approved by CEN as a EN ISO 11073-10471:2011 without any modification. BS EN ISO 11073-10471:2011 ISO/IEEE 11073-10471:2010(E) ISO 2010 All rights reserved IEEE 2010 All rights reserved iiiContents Page Foreword. . v Introduction.vii 1. Overview. . 1 1.

17、1 Scope. 1 1.2 Purpose. . 2 1.3 Context. . 2 2. Normative references . 2 3. Definitions, acronyms, and abbreviations 2 3.1 Definitions. 3 3.2 Acronyms and abbreviations. 3 4. Introduction to ISO/IEEE 11073 personal health devices. 3 4.1 General. . 3 4.2 Introduction to IEEE Std 11073-20601 modeling

18、constructs. 4 5. Independent living activity hub device concepts and modalities . . 5 5.1 General. . 5 5.2 Concepts. . 5 5.3 Collected data. . 5 6. Independent living activity hub domain information model . 7 6.1 Overview. 7 6.2 Class extensions . . 7 6.3 Object instance diagram 7 6.4 Types of confi

19、guration 9 6.5 MDS object . 10 6.6 Numeric objects . . 13 6.7 Real-time sample array objects . 13 6.8 Enumeration objects 13 6.9 PM-store objects . 26 6.10 Scanner objects . 26 6.11 Class extension objects . 26 6.12 Independent living activity hub information model extensibility rules. . 26 7. Indep

20、endent living activity hub service model 27 7.1 General. . 27 7.2 Object access services. 27 7.3 Object access event report services. 29 BS EN ISO 11073-10471:2011ISO/IEEE 11073-10471:2010(E) iv ISO 2010 All rights reserved IEEE 2010 All rights reserved8. Independent living activity hub communicatio

21、n model 29 8.1 Overview 29 8.2 Communication characteristics 29 8.3 Association procedure 30 8.4 Configuring procedure . 31 8.5 Operating procedure. 32 8.6 Time synchronization. 32 9. Test associations . 32 9.1 Behavior with standard configuration 33 9.2 Behavior with extended configurations 33 10.

22、Conformance. 33 10.1 Applicability. 33 10.2 Conformance specification. 33 10.3 Levels of conformance. 34 10.4 ICSs 34 Annex A (informative) Bibliography. 39 Annex B (normative) Any additional ASN.1 definitions. 40 Annex C (normative) Allocation of identifiers 43 Annex D (informative) Message sequenc

23、e examples . 45 Annex E (informative) Protocol data unit examples. 47 BS EN ISO 11073-10471:2011ISO/IEEE 11073-10471:2010(E) ISO 2010 All rights reserved IEEE 2010 All rights reserved vForeword ISO (the International Organization for Standardization) is a worldwide federation of national standards b

24、odies (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 the right to be represented on that committee. International organizati

25、ons, 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 Standards documents are developed within the IEEE Societies and the Stan

26、dards 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 together volunteers representing varied viewpoints and interests to

27、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 process, the IEEE does not independently evaluate, test, or verify the accu

28、racy 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 bodies for voting. Publication as an International Standard requires

29、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 standard, no position is taken with respect to the existence or validity o

30、f 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 or patent claims or determining whether any licensing terms or conditi

31、ons 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 expressly advised that determination of the validity of any patent rights,

32、 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 11073-10471 was prepared by the 11073 Committee of the Engineering in Medicine and Biology Society of the IEEE (as IEEE Std 110

33、73-10471-2008). It was adopted by Technical Committee ISO/TC 215, Health informatics, in parallel with its approval by the ISO member bodies, under the “fast-track procedure” defined in the Partner Standards Development Organization cooperation agreement between ISO and IEEE. Both parties are respon

34、sible for the maintenance of this document. ISO/IEEE 11073 consists of the following parts, under the general title Health informatics Personal health device communication (text in parentheses gives a variant of subtitle): Part 10101: (Point-of-care medical device communication) Nomenclature Part 10

35、201: Domain information model Part 10404: Device specialization Pulse oximeter BS EN ISO 11073-10471:2011ISO/IEEE 11073-10471:2010(E) vi ISO 2010 All rights reserved IEEE 2010 All rights reserved Part 10407: Device specialization Blood pressure monitor Part 10408: (Point-of-care medical device commu

36、nication) Device specialization Thermometer Part 10415: (Point-of-care medical device communication) Device specialization Weighing scale Part 10417: Device specialization Glucose meter Part 10471: (Point-of-care medical device communication) Device specialization Independant living activity hub Par

37、t 20101: (Point-of-care medical device communication) Application profiles Base standard Part 20601: (Point-of-care medical device communication) Application profile Optimized exchange protocol Part 30200: (Point-of-care medical device communication) Transport profile Cable connected Part 30300: (Po

38、int-of-care medical device communication) Transport profile Infrared wireless BS EN ISO 11073-10471:2011ISO/IEEE 11073-10471:2010(E) ISO 2010 All rights reserved IEEE 2010 All rights reserved viiIntroduction ISO/IEEE 11073 standards enable communication between medical devices and external computer

39、systems. This document uses the optimized framework created in IEEE Std 11073-20601aand describes a specific, interoperable communication approach for independent living activity hubs. These standards align with, and draw upon, the existing clinically focused standards to provide support for communi

40、cation of data from clinical or personal health devices. aFor information on references, see Clause 2. BS EN ISO 11073-10471:2011BS EN ISO 11073-10471:2011INTERNATIONAL STANDARD ISO/IEEE 11073-10471:2010(E) ISO 2010 All rights reserved IEEE 2010 All rights reserved 1IMPORTANT NOTICE: This standard i

41、s not intended to assure safety, security, health, or environmental protection in all circumstances. Implementers of the standard are responsible for determining appropriate safety, security, environmental, and health practices or regulatory requirements. This IEEE document is made available for use

42、 subject to important notices and legal disclaimers. These notices and disclaimers appear in all publications containing this document and may be found under the heading “Important Notice” or “Important Notices and Disclaimers Concerning IEEE Documents.” They can also be obtained on request from IEE

43、E or viewed at http:/standards.ieee.org/IPR/disclaimers.html. 1. Overview 1.1 Scope Within the context of the ISO/IEEE 11073 family of standards for device communication, this standard establishes a normative definition of the communication between independent living activity hubs and managers (e.g.

44、, cell phones, personal computers, personal health appliances, and set top boxes) in a manner that enables plug-and-play interoperability. It leverages appropriate portions of existing standards including ISO/IEEE 11073 terminology and information models. It specifies the use of specific term codes,

45、 formats, and behaviors in telehealth environments restricting ambiguity in base frameworks in favor of interoperability. This standard defines a common core of communication functionality for independent living activity hubs. In this context, independent living activity hubs are defined as devices

46、that communicate with simple situation monitors (binary sensors), normalize information received from the simple environmental monitors, and provide this normalized information to one or more managers. This information can be examined (for example) to determine when a persons activities/behaviors ha

47、ve deviated significantly from what is normal for them such that relevant parties can be notified. Independent living activity hubs will normalize information from the following simple situation monitors (binary sensors) for the initial release of the proposed standard: fall sensor, motion sensor, d

48、oor sensor, bed/chair occupancy sensor, light switch sensor, smoke sensor, (ambient) temperature threshold sensor, personal emergency response system (PERS), and enuresis sensor (bed-wetting). Health informatics Personal health device communication Part 10471: Device specialization Independant livin

49、g activity hub BS EN ISO 11073-10471:2011ISO/IEEE 11073-10471:2010(E) 2 ISO 2010 All rights reserved IEEE 2010 All rights reserved1.2 Purpose This standard addresses a need for an openly defined, independent standard for controlling information exchange to and from personal health devices and managers (e.g., cell phones, personal computers, personal health appliances, and set top boxes). Interoperability is the key to growing the potential market for these d

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