1、BSI Standards PublicationBS EN ISO 11073-10103:2013Health informatics Point-of-care medical devicecommunicationPart 10103: Nomenclature Implantabledevice, cardiacBS EN ISO 11073-10103:2013Incorporating corrigendum June 2014BS EN ISO 11073-10103:2013 BRITISH STANDARDNational forewordThis British Stan
2、dard is the UK implementation of EN ISO 11073-10103:2013. It is identical to ISO/IEEE 11073-10103:2014.The UK participation in its preparation was entrusted to Technical Committee IST/35, Health informatics.A list of organizations represented on this committee can be obtained on request to its secre
3、tary.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 2014. Published by BSI Standards Limited 2014ISBN 978 0 580 86986 0ICS 35.240.80Compliance with a British Standard cannot
4、 confer immunity from legal obligations.This British Standard was published under the authority of the Standards Policy and Strategy Committee on 28 February 2014.Amendments/corrigenda issued since publicationDate Text affected30 June 2014 Implementation of CEN correction notice 21 May 2014: impleme
5、nts ISO/IEEE corrected text 01 May 2014, which removes IEEE licensing text from footersEUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN ISO 11073-10103 December 2013 ICS 35.240.80 English Version Health informatics - Point-of-care medical device communication - Part 10103: Nomenclature - Implant
6、able device, cardiac (ISO/IEEE 11073-10103:2014, Corrected version 2014-05-01) Informatique de sant - Communication entre dispositifs mdicaux sur le site des soins - Partie 10103: Nomenclature - Dispositif implantable, cardiaque (ISO/IEEE 11073-10103:2014, Version corrige 2014-05-01) Medizinische In
7、formatik - Kommunikation patientennaher medizinischer Gerte - Teil 10103: Nomenklatur - Implantierbare kardiologische Gerte (ISO/IEEE 11073-10103:2014, korrigierte Fassung 2014-05-01) This European Standard was approved by CEN on 14 December 2013. CEN members are bound to comply with the CEN/CENELEC
8、 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-CENELEC Management Centre or t
9、o 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 same status as the offici
10、al 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, Luxembourg, Malta, Netherlands, N
11、orway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and United Kingdom. EUROPEAN COMMITTEE FOR STANDARDIZATION COMIT EUROPEN DE NORMALISATION EUROPISCHES KOMITEE FR NORMUNG CEN-CENELEC Management Centre: Avenue Marnix 17, B-1000 Brussels 2013 CEN All rights of ex
12、ploitation in any form and by any means reserved worldwide for CEN national Members. Ref. No. EN ISO 11073-10103:2013 EEN ISO 11073-10103:2013 (E) 3 Foreword This document (EN ISO 11073-10103:2013) has been prepared by Technical Committee ISO/TC 215 “Health informatics” in collaboration with Technic
13、al 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 August 2014, and conflicting national standards shall be withd
14、rawn at the latest by August 2014. 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 CEN-CENELEC Internal Regulations,
15、the national standards organizations 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, Hungary, Iceland, Ireland, Italy, Lat
16、via, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the United Kingdom. Endorsement notice The text of ISO/IEEE 11073-10103:2014, Corrected version 2014-05-01 has been approved by CEN as EN ISO 11073-10103:2013
17、 without any modification. BS EN ISO 11073-10103:2013EN ISO 11073-10103:2013 (E)ISO/IEEE 11073-10103:2014(E) IEEE 2012 All rights reserved iiiForeword ISO (the International Organization for Standardization) is a worldwide federation of national standards bodies (ISO member bodies). The work of prep
18、aring 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, in
19、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 IEEE S
20、tandards 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 are n
21、ot 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 contained in
22、 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 member bod
23、ies 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 therewith
24、. 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 submission
25、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 right
26、s, is entirely their own responsibility. Further information may be obtained from ISO or the IEEE Standards Association. ISO/IEEE 11073-10103 was prepared by the Substations Committee of the IEEE Power Engineering Society of the IEEE (as IEEE 11073-10103-2013). It was adopted by Technical Committee
27、ISO/TC 215, Lung ventilators, 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. IEEE is responsible for the maintenance of this document with participation and
28、 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 parentheses gives a variant of subtitle): Part 00103: Overview Part 10101: (Point-of-care medical device communication) Nomenclature
29、 Part 10102: (Point-of-care medical device communication) Nomenclature Annotated ECG Part 10103: (Point-of-care medical device communication) Nomenclature Implantable device, cardiac Part 10201: (Point-of-care medical device communication) Domain information model Part 10404: Device specialization P
30、ulse oximeter BS EN ISO 11073-10103:2013ISO/IEEE 11073-10103:2014(E)ISO/IEEE 11073-10103:2014(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 specializa
31、tion Thermometer Part 10415: Device specialization Weighing scale Part 10417: Device specialization Glucose meter Part 10418: Device specialization International Normalized Ratio (INR) monitor Part 10420: Device specialization Body composition analyzer Part 10421: Device specialization Peak expirato
32、ry flow monitor (peak flow) Part 10441: Device specialization Cardiovascular fitness and activity monitor Part 10471: Device specialization Independant living activity hub Part 10472: Device specialization Medication monitor Part 20101: (Point-of-care medical device communication) Application profil
33、es 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: (Point-of-care medical devi
34、ce 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) Encoding rules This correct
35、ed version of ISO 11073-10417:2014 incorporates the following correction: the text “Authorized licensed use limited to: IEEE Standards Staff and authorized IEEE Sponsor Ballot Participants. Downloaded on May 28,2013 at 14:27:23 UTC from IEEE Xplore. Restrictions apply.“ has been deleted from the foo
36、ter. BS EN ISO 11073-10103:2013ISO/IEEE 11073-10103:2014(E)Part 10103: NomenclatureImplantable device, cardiac Sponsored by the IEEE 11073 Standard Committee IEEE 3 Park Avenue New York, NY 10016-5997 USA 27 August 2012 IEEE Engineering in Medicine and Biology Society IEEE Std 11073-10103-2012Health
37、 informaticsPoint-of-care medical device communication BS EN ISO 11073-10103:2013BS EN ISO 11073-10103:2013,(6WG70+HDOWKLQIRUPDWLFV3RLQWRIFDUHPHGLFDOGHYLFHFRPPXQLFDWLRQ 3DUW1RPHQFODWXUH,PSODQWDEOHGHYLFHFDUGLDF6SRQVRU,(706WDQGDUGV +1 978 750 8400. Permission to photocopy portions of any individual st
38、andard for educational classroom use can also be obtained through the Copyright Clearance Center. BS EN ISO 11073-10103:2013IEEE Std 11073-10103-2012iv Copyright 2012 IEEE. All rights reserved. Notice to users Laws and regulations Users of IEEE Standards documents should consult all applicable laws
39、and regulations. Compliance with 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
40、its standards, intend to urge action 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 referenc
41、e, in laws and regulations, and 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. U
42、pdating of IEEE documents Users 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
43、 consists of the current edition 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 Webs
44、ite at http:/standards.ieee.org/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
45、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 EN ISO 11073-10103:2013IEEE Std 11073-10103-2012v Copyright 2012 IEEE. All rights reserved. Patents Attention is called to the
46、 possibility that implementation of this standard may require use of subject matter covered by patent rights. By publication of this standard, no position is taken by the IEEE with respect to the existence or validity of any patent rights in connection therewith. If a patent holder or patent applica
47、nt has filed a statement of assurance via an Accepted Letter of Assurance, then the statement is listed on the IEEE-SA Website at http:/standards.ieee.org/about/sasb/patcom/patents.html. Letters of Assurance may indicate whether the Submitter is willing or unwilling to grant licenses under patent ri
48、ghts without compensation or under reasonable rates, with reasonable terms and conditions that are demonstrably free of any unfair discrimination to applicants desiring to obtain such licenses. Essential Patent Claims may exist for which a Letter of Assurance has not been received. The IEEE is not responsible for identifying Essential Patent Claims for which a license may be required, for conducting inquiries into the legal validity or scope of Patents Claims, or determining whether an
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