ANSI IEEE 11073-10102-2012 Health informatics-Point-of-care medical device communication Part 10102 Nomenclature-Annotated ECG.pdf

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1、 Part 10102: NomenclatureAnnotated ECG Sponsored 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 IEEE Std 11073

2、-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 Approved 30 September 2014 American Nation

3、al Standards Institute Abstract: The base IEEE 11073-10101 Nomenclature is extended by this standard to provide support for ECG annotation terminology. It may be used either in conjunction with other IEEE 11073 standards (e.g., ISO/IEEE 11073-10201:2001) or independently with other standards. The ma

4、jor subject areas addressed by the nomenclature 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: a

5、nnotated ECG, annotations, arrhythmias, cardiac rhythm, codes, ECG leads, ECG lead systems, ECG measurements, home monitoring, IEEE 11073-10102TM, medical device communication, nomenclature, pacemaker, patient monitoring, remote monitoring, terminology The Institute of Electrical and Electronics Eng

6、ineers, 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. Permissi

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19、natory. 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 the IEEE Standards Association. vi Copyright 2013 IEEE. All rights

20、 reserved. Participants At the time this standard was submitted to the IEEE-SA Standards Board for approval, the Engineering in Medicine and Biology (EMB/11073/EMBS_WG) Working Group had the following membership: Jan Wittenber, Chair Paul Schluter, Vice Chair Barry Brown Don Brodnick Franco Chiarugi

21、 Todd Cooper Kai Hassing Steve Kordik Harry Solomon Lars Steubesand Joel Xue The following members of the individual balloting committee voted on this standard. Balloters may have voted for approval, disapproval, or abstention. Christopher Biernacki Lyle Bullock Susan Burgess Keith Chow Malcolm Clar

22、ke Russell Davis Randall Groves Werner Hoelzl Noriyuki Ikeuchi Atsushi Ito Alexander Kraus Ahmad Mahinfallah Neal Mellen Bansi Patel Melvin Reynolds John Rhoads Bartien Sayogo Paul Schluter Gil Shultz Paul Steiner Walter Struppler John Vergis Jan Wittenber Paul Work Oren Yuen Daidi Zhong When the IE

23、EE-SA Standards Board approved this standard on 5 December 2012, it had the following membership: Richard H. Hulett, Chair John Kulick, Vice Chair Robert Grow, Past Chair Konstantinos Karachalios, Secretary Satish Aggarwal Masayuki Ariyoshi Peter Balma William Bartley Ted Burse Clint Chaplin Wael Wi

24、lliam Diab Jean-Philippe Faure Alexander Gelman Paul Houz Jim Hughes Young Kyun Kim Joseph L. Koepfinger* David J. Law Thomas Lee Hung Ling Oleg Logvinov Ted Olsen Gary Robinson Jon Walter Rosdahl Mike Seavey Yatin Trivedi Phil Winston Yu Yuan *Member Emeritus Also included are the following nonvoti

25、ng IEEE-SA Standards Board liaisons: Richard DeBlasio, DOE Representative Michael Janezic, NIST Representative Don Messina IEEE Standards Program Manager, Document Development Kathryn Bennett IEEE Standards Program Manager, Technical Program Development vii Copyright 2013 IEEE. All rights reserved.

26、Introduction This introduction is not part of IEEE Std 11073-10102-2012, Health informaticsPoint-of-care medical device communicationNomenclatureAnnotated ECG. This standard extends the base ISO/IEEE 11073-10101:2004anomenclature to provide support for electrocardiogram (ECG) annotation terminology.

27、 The major subject areas addressed by the nomenclature include ECG beat annotations, wave component annotations, rhythm annotations, and noise annotations. It also defines additional “global” and “per-lead” numeric observation identifiers, ECG lead systems, and additional ECG lead identifiers. The n

28、omenclature extensions may be used in conjunction with other IEEE 11073 standard components (e.g., ISO/IEEE 11073-10201:2004 B19b) or independently with other standards. aInformation on references can be found in Clause 2. bThe numbers in brackets correspond to those in the bibliography in Annex E.

29、viii Copyright 2013 IEEE. All rights reserved. Contents 1. Overview 1 1.1 Scope . 1 1.2 Purpose 1 1.3 Audience 2 1.4 Context 2 2. Normative references 3 3. Definitions, acronyms, and abbreviations 3 3.1 Definitions . 3 3.2 Acronyms and abbreviations . 4 4. Introduction to IEEE Std 11073-10102 5 4.1

30、Clinical background . 5 5. Nomenclature requirements 7 5.1 Overview . 7 5.2 Scope requirements 7 5.3 Organizational structure requirements . 7 5.4 Semantic requirements. 7 5.5 Distribution format requirements . 7 6. Nomenclature structure 8 7. Conformance 8 8. Extensibility and versioning . 10 Annex

31、 A (normative) Base terms . 11 Annex B (normative) Expanded terms and numeric codes 68 Annex C (informative) Schema and XML for annotated ECG nomenclature 92 Annex D (informative) Cross-references to other ECG standards .169 Annex E (informative) Bibliography 175 1 Copyright 2013 IEEE. All rights re

32、served. Health informaticsPoint-of-care medical device communication Part 10102: NomenclatureAnnotated ECG IMPORTANT NOTICE: IEEE Standards documents are not intended to ensure safety, health, or environmental protection, or ensure against interference with or from other devices or networks. Impleme

33、nters of IEEE Standards documents are responsible for determining and complying with all appropriate safety, security, environmental, health, and interference protection practices and all applicable laws and regulations. This IEEE document is made available for use subject to important notices and l

34、egal disclaimers. These 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

35、.org/IPR/disclaimers.html. 1. Overview 1.1 Scope This standard extends the base ISO/IEEE 11073-10101:20041to provide support for ECG annotation terminology. Major subject areas addressed by the nomenclature include ECG beat annotations, wave component annotations, rhythm annotations, and noise annot

36、ations. It also defines additional “global” and “per-lead” numeric observation identifiers, ECG lead systems, and additional ECG lead identifiers. The nomenclature extensions may be used in conjunction with other IEEE 11073 standard components (e.g., ISO/IEEE 11073-10201:2004 B192) or independently

37、with other standards. 1.2 Purpose This standard provides a unified and comprehensive terminology for ECG annotation semantics, making it suitable for medical device data exchange that requires inclusion of ECG annotations. This standard consolidates numerous other standard and nonstandard terminolog

38、ies that are in current use, resulting in the harmonization of how ECG annotation information is identified, enabling interoperability, and providing information exchange at the application level. 1Information on references can be found in Clause 2. 2The numbers in brackets correspond to those of th

39、e bibliography in Annex E. IEEE Std 11073-10102-2012 Health informaticsPoint-of-care medical device communication Part 10102: NomenclatureAnnotated ECG 2 Copyright 2013 IEEE. All rights reserved. Currently, many terminologies and protocols, both standard and vendor specific, are used to manage and e

40、xchange ECG annotation information. As a result, protocol converters and translators are required to integrate systems and applications, typically with some degree of semantic loss and noninteroperability. This standard provides a single terminology that is capable of supporting applications that re

41、quire ECG annotations, including evaluation of patient condition (e.g., reviewing ECG data at the point-of-care or remotely) as well as clinical research (e.g., electronically submitting clinical drug trial evidence supporting the efficacy of a new medication). In addition to incorporating ECG annot

42、ations into an ISO/IEEE 11073-based information stream acquired at the bedside, the underlying nomenclature can also be used in other persistent and communication standards e.g., Health Level Seven International (HL7) V2 and V3, and Digital Imaging and Communications in Medicine (DICOM) for use by v

43、arious applications, including clinical information systems, electronic patient records, and clinical research. 1.3 Audience The audience for this document is those who work with monitoring and diagnostic ECG information in the context of systems integration. This may include but is not limited to t

44、he following roles: Cardiologist or electrophysiologist physicians Heart and device clinic specialists or staff Primary care physicians Clinic information technologists Clinic information system vendor engineers Academic and clinical research scientists Regulatory and quality management agencies Cli

45、ncal trial and research results reporting Medical device and system development engineers The following clinical applications are facilitated by this interoperability enabled by this standard. This may include but is not limited to the following activities: Clinical trial and research results report

46、ing HL7 annotated electrocardiogram (aECG), Clinical Data Interchange Standards Consortium (CDISC), and others Transfer of ECG data in an interoperable manner DICOM, HL7, IEEE 11073, Integrating the Healthcare Enterprise Patient Care Devices (IHE PCD), and other communication protocols Algorithm dev

47、elopment and performance evaluation Sophisticated real-time data exchange with option to retrospectively review and correct data 1.4 Context This nomenclature has been developed within the context of the broader ISO/IEEE 11073 Health InformaticsPoint-of-Care Medical Device Communication standards. I

48、ts goal is to be consistent with existing 11073 standards and information models. IEEE Std 11073-10102-2012 Health informaticsPoint-of-care medical device communication Part 10102: NomenclatureAnnotated ECG 3 Copyright 2013 IEEE. All rights reserved. 2. Normative references The following referenced

49、documents are indispensable for the application of this document (i.e., they must be understood and used, so that each referenced document is cited in text and its relationship to this document is explained). For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments or corrigenda) applies. ANSI/AAMI EC71-2001, Standard Communications Protocol for Computer Assisted-Electrocardiography.3ISO/IEEE 11073-10101:2004, Health infor