BS EN ISO 11073-10415-2011 Health informatics Personal health device communication Device specialization Weighing scale《健康信息学 个人健康设备通信 装置专业化 体重计》.pdf

1、raising standards worldwideNO COPYING WITHOUT BSI PERMISSION EXCEPT AS PERMITTED BY COPYRIGHT LAWBSI Standards PublicationBS EN ISO 11073-10415:2011Health informatics Personal health device communicationPart 10415: Device specialization Weighing scaleIncorporating corrigendum March 2013BS EN ISO 110

2、73-10415:2011 BRITISH STANDARDNational forewordThis British Standard is the UK implementation ofEN ISO 11073-10415:2011. It is identical to ISO/IEEE 11073-10415:2010.The UK participation in its preparation was entrusted to Technical Committee IST/35, Health informatics.A list of organizations repres

3、ented 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. The British Standards Institution 2013. Published by BSI Standards Limited 2013 ISBN 978 0 5

4、80 81981 0 ICS 35.240.80 Compliance with a British 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 2011. Amendments/corrigenda issued since publicationDate Text affected31 March

5、2013 Correction to National ForewordEUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN ISO 11073-10415 March 2011 ICS 35.240.80 English Version Health informatics - Personal health device communication - Part 10415: Device specialization - Weighing scale (ISO/IEEE 11073-10415:2010) Informatique de

6、 sant - Communication entre dispositifs de sant personnels - Partie 10415: Spcialisation des dispositifs - Plateau de balance (ISO/IEEE 11073-10415:2010) Medizinische Informatik - Kommunikation von Gerten fr die persnliche Gesundheit - Teil 10415: Gertespezifikation - Waage (ISO/IEEE 11073-10415:201

7、0) This European 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 re

8、ferences 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 language made by translation under the responsibility of a

9、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, Denmark, Estonia, Finland, France, Germany, Greece, Hungary,

10、Iceland, Ireland, 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: Av

11、enue Marnix 17, 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 11073-10415:2011: EBS EN ISO 11073-10415:2011EN ISO 11073-10415:2011 (E) 3 Foreword The text of ISO/IEEE 11073-10415:2010 has been prepared by

12、 Technical Committee ISO/TC 215 “Health informatics” of the International Organization for Standardization (ISO) and has been taken over as EN ISO 11073-10415:2011 by Technical Committee CEN/TC 251 “Health informatics” the secretariat of which is held by NEN. This European Standard shall be given th

13、e status of a 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

14、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 organizations of the following countries are bound to implement this European Standard: Austria,

15、Belgium, Bulgaria, 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. Endor

16、sement notice The text of ISO/IEEE 11073-10415:2010 has been approved by CEN as a EN ISO 11073-10415:2011 without any modification. BS EN ISO 11073-10415:2011ISO/IEEE 11073-10415:2010(E) ISO 2010 All rights reserved IEEE 2010 All rights reserved iiiContents Page Foreword. v Introduction.vii 1. Overv

17、iew. 1 1.1 Scope 1 1.2 Purpose. 1 1.3 Context. 2 2. Normative references 2 3. Definitions, acronyms, and abbreviations. 2 3.1 Definitions 2 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 11073-20601 modeling const

18、ructs. 4 5. Weighing scale device concepts and modalities . 4 5.1 General. 4 5.2 Body weight . 5 5.3 Body height 5 5.4 Body mass index 5 6. Weighing scale domain information model 5 6.1 Overview 5 6.2 Class extensions . 5 6.3 Object instance diagram. 6 6.4 Types of configuration . 7 6.5 Medical devi

19、ce system object 8 6.6 Numeric objects . 11 6.7 Real-time sample array objects 15 6.8 Enumeration objects. 15 6.9 PM-store objects 15 6.10 Scanner objects 15 6.11 Class extension objects 15 6.12 Weighing scale information model extensibility rules. 15 7. Weighing scale service model. 15 7.1 General.

20、 15 7.2 Object access services 15 7.3 Object access event report services 17 BS EN ISO 11073-10415:2011ISO/IEEE 11073-10415:2010(E) iv ISO 2010 All rights reserved IEEE 2010 All rights reserved8. Weighing scale communication model . 17 8.1 Overview 17 8.2 Communications characteristics. 17 8.3 Assoc

21、iation procedure 18 8.4 Configuring procedure . 19 8.5 Operating procedure. 21 8.6 Time synchronization. 21 9. Test associations . 21 9.1 Behavior with standard configuration 22 9.2 Behavior with extended configurations 22 10. Conformance. 22 10.1 Applicability. 22 10.2 Conformance specification. 22

22、 10.3 Levels of conformance. 23 10.4 Implementation conformance statements. 23 Annex A (informative) Bibliography. 28 Annex B (normative) Any additional ASN.1 definitions 29 Annex C (normative) Allocation of identifiers . 30 Annex D (informative) Message sequence examples . 31 Annex E (informative)

23、Protocol data unit examples. 33 BS EN ISO 11073-10415:2011ISO/IEEE 11073-10415:2010(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 bodies (ISO member bodies). The work of

24、 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 organizations, governmental and non-governmental

25、, 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 Standards Coordinating Committees of the I

26、EEE 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 achieve the final product. Volunteers

27、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 accuracy of any of the information contain

28、ed 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 approval by at least 75 % of the membe

29、r 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 of any patent rights in connection ther

30、ewith. 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 conditions provided in connection with submis

31、sion 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, and the risk of infringement of such

32、rights, is entirely their own responsibility. Further information may be obtained from ISO or the IEEE Standards Association. ISO/IEEE 11073-10415 was prepared by the 11073 Committee of the Engineering in Medicine and Biology Society of the IEEE (as IEEE Std 11073-10415-2008). It was adopted by Tech

33、nical 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 responsible for the maintenance of this docu

34、ment. 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 10201: Domain information model Part 104

35、04: Device specialization Pulse oximeter BS EN ISO 11073-10415:2011ISO/IEEE 11073-10415:2010(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 communication) Device specialization Thermo

36、meter 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 Part 20101: (Point-of-care medical device

37、 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: (Point-of-care medical device communicati

38、on) Transport profile Infrared wireless BS EN ISO 11073-10415:2011ISO/IEEE 11073-10415:2010(E) ISO 2010 All rights reserved IEEE 2010 All rights reserved viiIntroduction ISO/IEEE 11073 standards enable communication between medical devices and external computer systems. This document uses the optimi

39、zed framework created in IEEE Std 11073-20601aand describes a specific, interoperable communication approach for weighing scales. These standards align with, and draw upon, the existing clinically focused standards to provide support for communication of data from clinical or personal health devices

40、. aFor information on references, see Clause 2. BS EN ISO 11073-10415:2011BS EN ISO 11073-10415:2011INTERNATIONAL STANDARD ISO/IEEE 11073-10415:2010(E) ISO 2010 All rights reserved IEEE 2010 All rights reserved 1IMPORTANT NOTICE: This standard is not intended to assure safety, security, health, or e

41、nvironmental 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 subject to important notices and legal disclaimers. Th

42、ese 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 IEEE or viewed at http:/standards.ieee.org/IPR/disclaimers

43、.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 communication between personal telehealth weighing scale devices and compute engines (e.g., cell phones, personal computers, persona

44、l 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, information models, application profile standards, and transport standards. It specifies the use of specific

45、 term codes, formats, and behaviors in telehealth environments restricting optionality in base frameworks in favor of interoperability. This standard defines a common core of communication functionality for personal telehealth weighing scales. 1.2 Purpose This standard addresses a need for an openly

46、 defined, independent standard for controlling information exchange to and from personal health devices and compute engines (e.g., cell phones, personal computers, personal health appliances, and set top boxes). Interoperability is the key to growing the potential market for these devices and to ena

47、bling people to be better informed participants in the management of their health. Health informatics Personal health device communication Part 10415: Device specialization Weighing scale BS EN ISO 11073-10415:2011ISO/IEEE 11073-10415:2010(E) 2 ISO 2010 All rights reserved IEEE 2010 All rights reser

48、ved1.3 Context See IEEE Std 11073-20601TMfor an overview of the environment within which this standard is written. This document, IEEE Std 11073-10415, defines the device specialization for the weighing scale, being a specific agent type, and it provides a description of the device concepts, its cap

49、abilities, and its implementation according to this standard. This standard is based on IEEE Std 11073-20601, which in turn draws information from both ISO/IEEE 11073-10201:2004 B41and ISO/IEEE 11073-20101:2004 B5. The medical device encoding rules (MDER) used within this standard are fully described in IEEE Std 11073-20601. This standard reproduces relevant portions of the nomenclature found in ISO/IEEE 11073-10101:2004 B3 and adds new nomenclature cod