1、BSI Standards PublicationBS EN ISO 11073-10102:2014Health informatics Point-of-care medical devicecommunicationPart 10102: Nomenclature AnnotatedECGBS EN ISO 11073-10102:2014 BRITISH STANDARDNational forewordThis British Standard is the UK implementation of EN ISO11073-10102:2014.The UK participatio
2、n 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 secretary.This publication does not purport to include all the necessaryprovisions of a contract. Users are responsible for its c
3、orrectapplication. The British Standards Institution 2014. Published by BSI StandardsLimited 2014ISBN 978 0 580 83437 0ICS 35.240.80Compliance with a British Standard cannot confer immunity fromlegal obligations.This British Standard was published under the authority of theStandards Policy and Strat
4、egy Committee on 31 March 2014.Amendments issued since publicationDate Text affectedEUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN ISO 11073-10102 March 2014 ICS 35.240.80 English Version Health informatics - Point-of-care medical device communication - Part 10102: Nomenclature - Annotated ECG
5、 (ISO/IEEE 11073-10102:2014) Informatique de sant - Communication entre dispositifs mdicaux sur le site des soins - Partie 10102: Nomenclature - ECG annot (ISO/IEEE 11073-10102:2014)This European Standard was approved by CEN on 14 December 2013. CEN members are bound to comply with the CEN/CENELEC I
6、nternal 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 to
7、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 official
8、 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, Nor
9、way, 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 2014 CEN All rights of expl
10、oitation in any form and by any means reserved worldwide for CEN national Members. Ref. No. EN ISO 11073-10102:2014 EBS EN ISO 11073-10102:2014EN ISO 11073-10102:2014 (E) 3 Foreword This document (EN ISO 11073-10102:2014) has been prepared by Technical Committee ISO/TC 215 “Health informatics” in co
11、llaboration 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 September 2014, and conflicting nation
12、al standards shall be withdrawn at the latest by September 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-
13、CENELEC Internal Regulations, 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
14、, 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/IEEE 11073-10102:2014 has been approved by CEN as EN ISO 11073-10102:2014
15、 without any modification. BS EN ISO 11073-10102:2014ISO/IEEE 11073-10102:2014(E) IEEE 2013 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 Standar
16、ds 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 liaison with ISO, also take
17、 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 Standards Association (IEEE-
18、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 not necessarily members of t
19、he 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 its standards. The main ta
20、sk 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 bodies casting a vote. Attenti
21、on 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. ISO/IEEE is not responsib
22、le 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 of a Letter of Assurance or
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24、sponsibility. Further information may be obtained from ISO or the IEEE Standards Association. ISO/IEEE 11073-10102 was prepared by the Substations Committee of the IEEE Power Engineering Society of the IEEE (as IEEE 1686-2007). It was adopted by Technical Committee ISO/TC 215, Lung ventilators, in p
25、arallel 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 input from ISO member bodies. ISO
26、/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 Part 10102: (Point-of-care medica
27、l 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 Pulse oximeter BS EN ISO 11073-1010
28、2:2014ISO/IEEE 11073-10102:2014(E) iv IEEE 2013 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 sc
29、ale 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 expiratory flow monitor (peak flow) Part 10441: Device specialization
30、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 profiles Base standard Part 20601: Application profile Optimized exc
31、hange 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) Interface profile Cabled Ethernet Part 90101
32、: (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 BS EN ISO 11073-10102:2014Part 10102: NomenclatureAnnotated ECG Sponsored
33、by the IEEE 11073 Standards Committee IEEE 3 Park Avenue New York, NY 10016-5997 USA 15 February 2013 IEEE Engineering in Medicine and Biology Society IEEE Std 11073-10102-2012Health informaticsPoint-of-care medical device communication BS EN ISO 11073-10102:2014BS EN ISO 11073-10102:2014IEEE Std 11
34、073-10102TM-2012 Health informaticsPoint-of-care medical device communication Part 10102: NomenclatureAnnotated ECG Sponsor IEEE 11073TMStandards Committee of the IEEE Engineering in Medicine and Biology Society Approved 5 December 2012 IEEE-SA Standards Board ISO/IEEE 11073-10102:2014(E)BS EN ISO 1
35、1073-10102:2014Abstract: The base IEEE 11073-10101 Nomenclature is extended by this standard to provide support for ECG annotation terminology. It ma y be used eit her in conjunction with other IEEE 11073 standards (e.g., ISO/IEEE 11073-10201:2001) or independently with other standards. The major su
36、bject areas addressed by the no menclature include ECG beat annotations, wave component annotations, rhythm annotations, and noise annotations. Additional “global” and “per-lead” numeric observation identifiers, ECG lead systems, and additional ECG lead identifiers also are defined. Keywords: annota
37、ted ECG, annotations, arrhythmias, cardiac rhythm, codes, ECG leads, ECG lead systems, ECG m easurements, home monitori ng, IEEE 11073-10102TM, medical device communication, nomenclature, pacemaker, patient monitoring, remote monitoring, terminology The Institute of Electrical and Electronics Engine
38、ers, Inc. 3 Park Avenue, New York, NY 10016-5997, USA Copyright 2013 by The Institute of Electrical and Electronics Engineers, Inc. All rights reserved. Published 15 February 2013. Printed in the United States of America. IEEE is a registered trademark in the U.S. Patent +1 978 750 8400. Permission
39、to photocopy portions of any individual standard for educational classroom use can also be obtained through the Copyright Clearance Center. ISO/IEEE 11073-10102:2014(E)iii Copyright 2013 IEEE. All rights reserved. BS EN ISO 11073-10102:2014iv Copyright 2013 IEEE. All rights reserved. Notice to users
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