EN ISO 11073-10420-2012 en Health informatics - Personal health device communication - Part 10420 Device specialization - Body composition analyzer《健康信息学 个人保健装置通信设备专门化 身体成分分析仪》.pdf

1、raising standards worldwideNO COPYING WITHOUT BSI PERMISSION EXCEPT AS PERMITTED BY COPYRIGHT LAWBSI Standards PublicationBS EN ISO 11073-10420:2012Health informatics Personalhealth device communicationPart 10420: Device specialization Body composition analyzer (ISO11073-10420:2012)BS EN ISO 11073-1

2、0420:2012 BRITISH STANDARDNational forewordThis British Standard is the UK implementation of EN ISO11073-10420:2012.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 t

3、o its secretary.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 79085 0ICS 35.240.80Compliance with a British Standar

4、d cannot 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 11073-10420 November

5、2012 ICS 35.240.80 English Version Health informatics - Personal health device communication - Part 10420: Device specialization - Body composition analyzer (ISO 11073-10420:2012) Informatique de sant - Communication entre dispositifs de sant personnels - Partie 10420: Spcialisation de dispositif -

6、Analyseur de composition corporelle (ISO 11073-10420:2012) This European Standard was approved by CEN on 20 October 2012. 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 witho

7、ut any alteration. Up-to-date lists and bibliographical references concerning 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 l

8、anguage made by translation under the responsibility of a CEN member 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, Den

9、mark, Estonia, 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 United Kingdom. EUROPEAN COMMITTE

10、E FOR STANDARDIZATION COMIT EUROPEN DE NORMALISATION EUROPISCHES KOMITEE FR NORMUNG Management Centre: Avenue Marnix 17, B-1000 Brussels 2012 CEN All rights of exploitation in any form and by any means reserved worldwide for CEN national Members. Ref. No. EN ISO 11073-10420:2012: EBS EN ISO 11073-10

11、420:2012EN ISO 11073-10420:2012 (E) 3 Foreword This document (EN ISO 11073-10420:2012) 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 sh

12、all 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 conflicting 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 m

13、ay 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 CEN/CENELEC Internal Regulations, the national standards organisations of the following countries are bound to implement this European Standard: Austri

14、a, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, 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,

15、 Switzerland, Turkey and the United Kingdom. Endorsement notice The text of ISO 11073-10420:2012 has been approved by CEN as a EN ISO 11073-10420:2012 without any modification. BS EN ISO 11073-10420:2012ISO/IEEE 11073-10420:2012(E) ISO 2012 All rights reserved IEEE 2012 All rights reserved iiiConten

16、ts 1. Overview 1 1.1 Scope . 1 1.2 Purpose 2 1.3 Context 2 2. Normative references 2 3. Definitions, acronyms, and abbreviations 3 3.1 Definitions . 3 3.2 Acronyms and abbreviations . 4 4. Introduction to ISO/IEEE 11073 personal health devices 4 4.1 General 4 4.2 Introduction to IEEE 11073-20601 mod

17、eling constructs 4 5. Body composition analyzer device concepts and modalities 5 5.1 General 5 5.2 Body fat . 6 5.3 Body height . 6 5.4 Body weight. 6 5.5 Body mass index 6 5.6 Fat free mass 6 5.7 Soft lean mass 6 5.8 Body water. 6 6. Body composition analyzer domain information model. 7 6.1 Overvie

18、w . 7 6.2 Class extensions. 7 6.3 Object instance diagram 7 6.4 Types of configuration. 8 6.5 Medical device system object 9 6.6 Numeric objects. 12 6.7 Real-time sample array objects 19 6.8 Enumeration objects 19 6.9 PM-store objects 20 6.10 Scanner objects 20 6.11 Class extension objects 20 6.12 B

19、ody composition analyzer information model extensibility rules . 20 7. Body composition analyzer service model . 20 7.1 General 20 7.2 Object access services 20 7.3 Object access event report services . 21 8. Body composition analyzer communication model 22 8.1 Overview . 22 8.2 Communications chara

20、cteristics 22 8.3 Association procedure . 22 8.4 Configuring procedure. 24 8.5 Operating procedure 26 8.6 Time synchronization 27 BS EN ISO 11073-10420:2012ISO/IEEE 11073-10420:2012(E) iv ISO 2012 All rights reserved IEEE 2012 All rights reserved9. Test associations. 27 9.1 Behavior with standard co

21、nfiguration 27 9.2 Behavior with extended configurations . 28 10. Conformance 28 10.1 Applicability 28 10.2 Conformance specification 28 10.3 Levels of conformance 28 10.4 Implementation conformance statements 29 Annex A (informative) Bibliography 34 Annex B (normative) Any additional ASN.1 definiti

22、ons . 35 Annex C (normative) Allocation of identifiers. 36 Annex D (informative) Message sequence examples. 37 Annex E (informative) Protocol data unit examples 39 E.1 General 39 E.2 Association information exchange 39 E.3 Configuration information exchange. 42 E.4 GET MDS attributes service . 47 E.

23、5 Data reporting 48 E.6 Disassociation . 49 Annex F (informative) IEEE list of particpants . 51 BS EN ISO 11073-10420:2012ISO/IEEE 11073-10420:2012(E) ISO 2012 All rights reserved IEEE 2012 All rights reserved vForeword ISO (the International Organization for Standardization) is a worldwide federati

24、on 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 the right to be represented on that committee

25、. 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 Standards documents are developed within the I

26、EEE 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 together volunteers representing varied vi

27、ewpoints 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 process, the IEEE does not independently evaluate

28、, test, or verify the accuracy of any of the information or the soundness of any judgments 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 fo

29、r 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 standard, no p

30、osition 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 or patent

31、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 expressly advi

32、sed 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 11073-10420 was prepared by the IEEE 11073 Standards Comittee of th

33、e IEEE Engineering in Medicine and Biology Society (as IEEE Std 11073-10420-2010). 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 procedure” defined in the Partner Standards Development Organization

34、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 parenthes

35、es 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 Part 10407: Device specialization Blood pressure monitor Part 1040

36、8: Device specialization Thermometer Part 10415: Device specialization Weighing scale BS EN ISO 11073-10420:2012ISO/IEEE 11073-10420:2012(E) vi ISO 2012 All rights reserved IEEE 2012 All rights reserved Part 10417: Device specialization Glucose meter Part 10420: Device specialization Body compositio

37、n 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 medical device communication) Application profiles Base standard Par

38、t 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 wireless Part 30400: (Point-of-care medical device communication) In

39、terface 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 waveform format) Encoding rulesBS EN ISO 11073-10420:2012ISO/IEE

40、E 11073-10420:2012(E) ISO 2012 All rights reserved IEEE 2012 All rights reserved viiIntroduction This introduction is not part of IEEE Std 11073-10420-2010, Health InformaticsPersonal health device communication Part 10420: Device specializationBody composition analyzer. ISO/IEEE 11073 standards ena

41、ble 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 medication monitoring devices and managers (e.g., cell phones,

42、 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 specifies the use of specific term codes, formats, and beha

43、viors in telehealth environments restricting ambiguity in base frameworks in favor of interoperability. This standard defines a common core of communication functionality for personal telehealth body composition analyzer devices. In this context, body composition analyzer devices are being used broa

44、dly to cover body composition analyzer devices that measure body impedances, and compute the various body components including body fat from the impedance. BS EN ISO 11073-10420:2012BS EN ISO 11073-10420:2012IMPORTANT NOTICE: This standard is not intended to ensure safety, security, health, or envir

45、onmental protection. 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 disclaime

46、rs 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 Sco

47、pe Within the context of the ISO/IEEE 11073 family of standards for device communication, this standard establishes a normative definition of the communication between personal body composition analyzing devices and managers (e.g. cell phones, personal computers, personal health appliances, set top

48、boxes) in a manner that enables plug-and-play interoperability. It leverages appropriate portions of existing standards including ISO/IEEE 11073 terminology and IEEE Std 11073-20601-20081information models. It specifies the use of specific term codes, formats, and behaviors in telehealth environment

49、s restricting optionality in base frameworks in favor of interoperability. This standard defines a common core of communication functionality for personal telehealth body composition analyzer devices. In this context, body composition analyzer devices are being used broadly to cover body composition analyzer devices that measure body impedances, and compute the various body components including body fat from the impedance. 1Information on references can be found