1、Health informatics Personal health device communicationPart 00103: OverviewBS ISO/IEEE 11073-00103:2015BS EN ISO 11073-00103:2017(ISO/IEEE 11073-00103:2015)BSI Standards PublicationWB11885_BSI_StandardCovs_2013_AW.indd 1 15/05/2013 15:06BS EN ISO 11073-00103:2017 BRITISH STANDARDNational forewordThi
2、s British Standard is the UK implementation of EN ISO 11073-00103:2017. It is identical to ISO/IEEE 11073-00103:2015. It supersedes BS ISO/IEEE 11073-00103:2015.The UK participation in its preparation was entrusted to Technical Committee IST/35, Health informatics.A list of organizations represented
3、 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 2017. Published by BSI Standards Limited 2017ISBN 978 0 580 931
4、66 6ICS 11.040.55; 35.240.80Compliance 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 2015.Amendments/corrigenda issued since publicationDate Text affected30 Apri
5、l 2017 This corrigendum renumbers BS ISO/IEEE 11073-00103:2015 as BS EN ISO 11073-00103:2017.EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN ISO 11073-00103 February 2017 ICS 11.040.55; 35.240.80 English Version Health informatics - Personal health device communication - Part 00103: Overview (I
6、SO/IEEE 11073-00103:2015) Informatique de sant - Communication entre dispositifs de sant personnels - Partie 00103: Aperu gnral (ISO/IEEE 11073-00103:2015) Medizinische Informatik - Kommunikation von Gerten fr die persnliche Gesundheit- Teil 00103: berblick (ISO/IEEE 11073-00103:2015) This European
7、Standard was approved by CEN on 16 January 2017. 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, Former Yugoslav Republic of Macedonia, France, Ge
10、rmany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and United Kingdom. EUROPEAN COMMITTEE FOR STANDARDIZATION COMIT EUROPEN DE NORMALISATION EUROPISCHES
11、KOMITEE FR NORMUNG CEN-CENELEC Management Centre: Avenue Marnix 17, B-1000 Brussels 2017 CEN All rights of exploitation in any form and by any means reserved worldwide for CEN national Members. Ref. No. EN ISO 11073-00103:2017 EEN ISO 11073-00103:2017 (E) 3 European foreword The text of ISO/IEEE 110
12、73-00103:2015 has been prepared by Technical Committee ISO/TC 215 “Health informatics” of the International Organization for Standardization (ISO) and has been taken over as EN ISO 11073-00103:2017 by Technical Committee CEN/TC 251 “Health informatics” the secretariat of which is held by NEN. This E
13、uropean Standard shall be given the status of a national standard, either by publication of an identical text or by endorsement, at the latest by August 2017, and conflicting national standards shall be withdrawn at the latest by August 2017. Attention is drawn to the possibility that some of the el
14、ements 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 CEN-CENELEC Internal Regulations, the national standards organizations of the following countries are bound to implement this
15、European Standard: Austria, 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, Serbia, S
16、lovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the United Kingdom. Endorsement notice The text of ISO 11073-00103:2015 has been approved by CEN as EN ISO 11073-00103:2017 without any modification. BS EN ISO 11073-00103:2017EN ISO 11073-00103:2017 (E)ISO/IEEE 11073-00103:2015(E) IEEE 2012
17、All rights reserved iiiForeword 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
18、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, in liaison with ISO, also take part in the work. ISO collaborates closely with the International Electrotechnical Commissi
19、on (IEC) on all 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
20、, approved by 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 esta
21、blishes 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 contained in its standards. The main task of technical committees is to prepare International Standards. Draft International Standa
22、rds 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 member bodies casting a vote. Attention is called to the possibility that implementation of this standard may require the use of
23、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 therewith. ISO/IEEE is not responsible for identifying essential patents or patent claims for which a license may be required, f
24、or 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 submission of a Letter of Assurance or a Patent Statement and Licensing Declaration Form, if any, or in any licensing agreements a
25、re 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 rights, is entirely their own responsibility. Further information may be obtained from ISO or the IEEE Standards Association
26、. ISO/IEEE 11073-00103 was prepared by the 11073 Committee of the Engineering in Medicine and Biology Society of the IEEE (as IEEE 11073-00103-2012). 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 pr
27、ocedure” 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
28、informatics Personal health device communication (text in 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-car
29、e medical device communication) Nomenclature Implantable device, cardiac Part 10201: (Point-of-care medical device communication) Domain information model Part 10404: Device specialization Pulse oximeter BS ISO/IEEE 11073-00103:2015BS EN ISO 11073-00103:2017ISO/IEEE 11073-00103:2015(E)ISO/IEEE 11073
30、-00103:2015(E) iv IEEE 2012 All rights reserved Part 10406: Device specialization Basic 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: Devi
31、ce specialization Glucose meter Part 10418: Device specialization International Normalized 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 fitne
32、ss and activity monitor Part 10442: (Point-of-care medical device communication) Device specialization Strength fitness equipment Part 10471: Device specialization Independent living activity hub Part 10472: Device specialization Medication monitor Part 20101: (Point-of-care medical device communica
33、tion) 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 wireless Part 30400: (Po
34、int-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 waveform format) Enc
35、oding rules BS ISO/IEEE 11073-00103:2015Part 00103: Overview Sponsored by the IEEE 11073 Standard Committee IEEE 3 Park Avenue nullw nullorknull null 1001nullnullnull nullA 31 Aunullst null1null IEEE Ennullineerinnull in nulldinullne and nullonullnull Sonullety IEEE Std 11073null00103nullnull01nulln
36、ulleanullth InnullormatinullsnullPersonanull heanullth devinulle nullommuninullationBS ISO/IEEE 11073-00103:2015BS EN ISO 11073-00103:2017ISO/IEEE 11073-00103:2015(E)Part 00103: Overview Sponsored by the IEEE 11073 Standard Committee IEEE 3 Park Avenue nullw nullorknull null 1001nullnullnull nullA 3
37、1 Aunullst null1null IEEE Ennullineerinnull in nulldinullne and nullonullnull Sonullety IEEE Std 11073null00103nullnull01nullnulleanullth InnullormatinullsnullPersonanull heanullth devinulle nullommuninullationBS ISO/IEEE 11073-00103:2015BS EN ISO 11073-00103:2017ISO/IEEE 11073-00103:2015(E)IEEE Std
38、 1173-00103TM-2012 Health informaticsPersonal health device communication Part 00103: Overview Sponsor IEEE 11073TMStandards Committee of the IEEE Engineering in Medicine and Biology Society Approved 14 May 2012 IEEE-SA Standards Board BS ISO/IEEE 11073-00103:2015Abstract: Within the context of the
39、ISO/IEEE 11073 family of standards for device communication, the landscape of transport-independent applications and information profiles for personal telehealth devices is described in this guide. Defined in these profiles are data exchange, data representation, and terminology for communication be
40、tween personal telehealth devices and compute engines (e.g., health appliances, set top boxes, cell phones, and personal computers). A definition of personal telehealth devices as devices used for life activity, wellness monitoring, and/or health monitoring in domestic home, communal home, and/or mo
41、bile applications is provided in this guide. Use cases relevant to these scenarios and environments are also presented. Keywords: IEEE 11073-00103, medical device communication, personal health devices The Institute of Electrical and Electronics Engineers, Inc. 3 Park Avenue, New York, NY 10016-5997
42、, USA Copyright 2012 by The Institute of Electrical and Electronics Engineers, Inc. All rights reserved. Published 31 August 2012. Printed in the United States of America. IEEE is a registered trademark in the U.S. Patent +1 978 750 8400. Permission to photocopy portions of any individual standard f
43、or educational classroom use can also be obtained through the Copyright Clearance Center. BS ISO/IEEE 11073-00103:2015iv Copyright 2012 IEEE. All rights reserved. Notice to users Laws and regulations Users of IEEE Standards documents should consult all applicable laws and regulations. Compliance wit
44、h the provisions of any IEEE Standards document does not imply compliance to any applicable regulatory requirements. Implementers of the standard are responsible for observing or referring to the applicable regulatory requirements. IEEE does not, by the publication of its standards, intend to urge a
45、ction that is not in compliance with applicable laws, and these documents may not be construed as doing so. Copyrights This document is copyrighted by the IEEE. It is made available for a wide variety of both public and private uses. These include both use, by reference, in laws and regulations, and
46、 use in private self-regulation, standardization, and the promotion of engineering practices and methods. By making this document available for use and adoption by public authorities and private users, the IEEE does not waive any rights in copyright to this document. Updating of IEEE documents Users
47、 of IEEE Standards documents should be aware that these documents may be superseded at any time by the issuance of new editions or may be amended from time to time through the issuance of amendments, corrigenda, or errata. An official IEEE document at any point in time consists of the current editio
48、n of the document together with any amendments, corrigenda, or errata then in effect. In order to determine whether a given document is the current edition and whether it has been amended through the issuance of amendments, corrigenda, or errata, visit the IEEE-SA Website at http:/standards.ieee.org
49、/index.html or contact the IEEE at the address listed previously. For more information about the IEEE Standards Association or the IEEE standards development process, visit IEEE-SA Website at http:/standards.ieee.org/index.html. Errata Errata, if any, for this and all other standards can be accessed at the following URL: http:/standards.ieee.org/findstds/errata/index.html. Users are encouraged to check this URL for errata periodically. BS ISO/I
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