BS EN ISO 11073-10472-2012 Health Informatics Personal health device communication Device specialization Medication monitor《健康信息学 个人健康设备通信 装置专门化 药物监控器》.pdf

1、raising standards worldwideNO COPYING WITHOUT BSI PERMISSION EXCEPT AS PERMITTED BY COPYRIGHT LAWBSI Standards PublicationBS EN ISO 11073-10472:2012Health Informatics Personalhealth device communicationPart 10472: Device specialization Medication monitor (ISO11073-10472:2012)BS EN ISO 11073-10472:20

2、12 BRITISH STANDARDNational forewordThis British Standard is the UK implementation of EN ISO11073-10472:2012.The UK participation in its preparation was entrusted to TechnicalCommittee IST/35, Health informatics.A list of organizations represented on this committee can beobtained on request to its s

3、ecretary.This publication does not purport to include all the necessaryprovisions of a contract. Users are responsible for its correctapplication. The British Standards Institution 2012. Published by BSI StandardsLimited 2012ISBN 978 0 580 79084 3ICS 35.240.80Compliance with a British Standard canno

4、t confer immunity fromlegal obligations.This British Standard was published under the authority of theStandards Policy and Strategy Committee on 30 November 2012.Amendments issued since publicationDate Text affectedEUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN ISO 11073-10472 November 2012 IC

5、S 35.240.80 English Version Health Informatics - Personal health device communication - Part 10472: Device specialization - Medication monitor (ISO 11073-10472:2012) Informatique de sant - Communication entre dispositifs de sant personnels - Partie 10472: Spcialisation des dispositifs - Moniteur de

6、surveillance de mdication (ISO 11073-10472:2012) Medizinische Informatik - Kommunikation von Gerten fr die persnliche Gesundheit - Teil 10472: Gertespezifikation - Medikamentenmonitoring (ISO 11073-10472:2012) This European Standard was approved by CEN on 20 October 2012. CEN members are bound to co

7、mply 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 concerning such national standards may be obtained on application to the CEN-CENEL

8、EC 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 its own language and notified to the CEN-CENELEC Management Centre has the

9、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, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembou

10、rg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and United Kingdom. EUROPEAN COMMITTEE FOR STANDARDIZATION COMIT EUROPEN DE NORMALISATION EUROPISCHES KOMITEE FR NORMUNG Management Centre: Avenue Marnix 17, B-1000 Brussels 2012 CEN All

11、 rights of exploitation in any form and by any means reserved worldwide for CEN national Members. Ref. No. EN ISO 11073-10472:2012: EBS EN ISO 11073-10472:2012EN ISO 11073-10472:2012 (E) 3 Foreword This document (EN ISO 11073-10472:2012) has been prepared by Technical Committee ISO/TC 215 “Health in

12、formatics“ 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 identical text or by endorsement, at the latest by May 2013, and conflict

13、ing national standards shall be withdrawn at the latest by May 2013. 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 held responsible for identifying any or all such patent rights. According to the

14、CEN/CENELEC Internal Regulations, the national standards organisations of the following countries are bound to implement this European Standard: Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hun

15、gary, 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 text of ISO 11073-10472:2012 has been approved by CEN as a EN ISO 11073-10472:201

16、2 without any modification. BS EN ISO 11073-10472:2012ISO/IEEE 11073-10472:2012(E) ISO 2012 All rights reserved IEEE 2012 All rights reserved iiiContents 1. Overview 1 1.1 Scope . 1 1.2 Purpose 2 1.3 Context 2 2. Normative references 2 3. Definitions, acronyms, and abbreviations 2 3.1 Definitions .

17、3 3.2 Acronyms and abbreviations . 3 4. Introduction to ISO/IEEE 11073 personal health devices 4 4.1 General 4 4.2 Introduction to IEEE 11073-20601 modeling constructs 4 5. Medication monitor device concepts and modalities 5 5.1 General 5 5.2 Model usage examples. 6 5.3 Medication dispensed 7 5.4 St

18、atus reporter 8 5.5 User feedback 8 5.6 Usage patterns 9 6. Medication monitor domain information model. 9 6.1 Overview . 9 6.2 Class extensions. 9 6.3 Object instance diagram 10 6.4 Types of configuration. 11 6.5 Medical device system object 12 6.6 Numeric objects. 16 6.7 Real-time sample array obj

19、ects 22 6.8 Enumeration objects 22 6.9 PM-store objects 27 6.10 Scanner objects 30 6.11 Class extension objects 31 6.12 Medication monitor information model extensibility rules . 31 7. Medication monitor service model . 31 7.1 General 31 7.2 Object access services 31 7.3 Object access event report s

20、ervices . 32 8. Medication monitor communication model 33 8.1 Overview . 33 8.2 Communications characteristics 33 8.3 Association procedure . 33 8.4 Configuring procedure. 35 8.5 Operating procedure 41 8.6 Time synchronization 42 9. Test associations. 42 BS EN ISO 11073-10472:2012ISO/IEEE 11073-1047

21、2:2012(E) iv ISO 2012 All rights reserved IEEE 2012 All rights reserved9.1 Behavior with standard configuration 42 9.2 Behavior with extended configurations . 43 10. Conformance 43 10.1 Applicability 43 10.2 Conformance specification 43 10.3 Levels of conformance 44 10.4 Implementation conformance s

22、tatements 44 Annex A (informative) Bibliography 50 Annex B (normative) Any additional ASN.1 definitions . 51 Annex C (normative) Allocation of identifiers. 52 Annex D (informative) Message sequence examples. 53 Annex E (informative) Protocol data unit examples 55 E.1 General 55 E.2 Association infor

23、mation exchange 55 E.3 Configuration information exchange. 58 E.4 GET MDS attributes service . 61 E.5 Data reporting 62 E.6 Disassociation . 63 Annex F (informative) IEEE list of participants 64 BS EN ISO 11073-10472:2012ISO/IEEE 11073-10472:2012(E) ISO 2012 All rights reserved IEEE 2012 All rights

24、reserved vForeword ISO (the International Organization for 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

25、 which a technical committee has been established has the 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 a

26、ll matters of electrotechnical standardization. IEEE Standards 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

27、 the American National Standards Institute, which brings 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

28、 to promote fairness in the consensus development process, 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 b

29、y the technical committees are circulated to the member 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 matte

30、r covered by patent rights. By publication of this standard, 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

31、 inquiries into the legal validity or scope of patents or 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

32、 or non-discriminatory. Users of this standard are expressly 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 11

33、073-10472 was prepared by the IEEE 11073 Standards Comittee of the IEEE Engineering in Medicine and Biology Society (as IEEE Std 11073-10472-2010). 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 proc

34、edure” defined in the Partner Standards Development Organization 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 in

35、formatics Personal health device communication (text in parentheses gives a variant of subtitle): Part 10101: (Point-of-care medical device communication) Nomenclature Part 10201: (Point-of-care medical device communication) Domain information model Part 10404: Device specialization Pulse oximeter P

36、art 10407: Device specialization Blood pressure monitor Part 10408: Device specialization Thermometer Part 10415: Device specialization Weighing scale BS EN ISO 11073-10472:2012ISO/IEEE 11073-10472:2012(E) vi ISO 2012 All rights reserved IEEE 2012 All rights reserved Part 10417: Device specializatio

37、n Glucose meter Part 10420: Device specialization Body composition analyzer Part 10421: Device specialization Peak expiratory flow monitor (peak flow) Part 10471: Device specialization Independant living activity hub Part 10472: Device specialization Medication monitor Part 20101: (Point-of-care med

38、ical 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 Part 30300: (Point-of-care medical device communication) Transport profile Infrared wir

39、eless 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: (Standard communication protocol) Computer-assisted electrocardiography Part 92001: (Medical

40、 waveform format) Encoding rulesBS EN ISO 11073-10472:2012ISO/IEEE 11073-10472:2012(E) ISO 2012 All rights reserved IEEE 2012 All rights reserved viiIntroduction This introduction is not part of IEEE Std 11073-10472-2012, Health InformaticsPersonal health device communicationPart 10472: Device speci

41、alizationMedication monitor. ISO/IEEE 11073 standards enable communication between medical devices and external computer systems. Within the context of the ISO/IEEE 11073 family of standards for device communication, this standard establishes a normative definition of the communication between medic

42、ation monitoring devices and managers (e.g., cell phones, personal computers, personal health appliances, 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 sp

43、ecifies the use of specific term codes, 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 medication monitors. In this context, medication monitors are define

44、d as devices that have the ability to determine and communicate (to a manager) measures of a users adherence to a medication regime. BS EN ISO 11073-10472:2012BS EN ISO 11073-10472:2012IMPORTANT NOTICE: This standard is not intended to ensure safety, security, health, or environmental protection in

45、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 subject to important notices and legal disclaimers. These notices and disclaimers

46、 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 IEEE or viewed at http:/standards.ieee.org/IPR/disclaimers.html. 1 Overview 1.1 Scope

47、 Within the context of the ISO/IEEE 11073 family of standards for device communication, this standard establishes a normative definition of the communication between medication monitoring devices and managers (e.g., cell phones, personal computers, personal health appliances, set top boxes) in a man

48、ner 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, formats, and behaviors in telehealth environments restricting ambiguity in base framework

49、s in favor of interoperability. This standard defines a common core of communication functionality for medication monitors. In this context, medication monitors are defined as devices that have the ability to determine and communicate (to a manager) measures of a users adherence to a medication regime. ISO/IEEE 11073-10472:2012(E) ISO 2012 All rights reserved IEEE 2012 All rights reserved 1Health informatics Personal health device communication P