BS EN ISO 11073-10103-2013 Health informatics Point-of-care medical device communication Nomenclature Implantable device cardiac《健康信息学 床旁检测医疗设备通信 命名 心脏可植入器械》.pdf

1、BS EN ISO 11073-10103:2013Health informatics Point-of-care medical devicecommunicationPart 10103: Nomenclature Implantabledevice, cardiacCopyright British Standards Institution Provided by IHS under license with BSI - Uncontrolled Copy Not for ResaleNo reproduction or networking permitted without li

2、cense from IHS-,-,-BS EN ISO 11073-10103:2013 BRITISH STANDARDNational forewordThis British Standard is the UK implementation of EN ISO11073-10103:2013. It is identical to ISO/IEEE 11073-10103:2014.The UK participation in its preparation was entrusted to TechnicalCommittee IST/35, Health informatics

3、.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 correctapplication. The British Standards Institution 2014. Published by BSI Standar

4、dsLimited 2014ISBN 978 0 580 83438 7ICS 35.240.80Compliance with a British Standard cannot confer immunity fromlegal obligations.This British Standard was published under the authority of theStandards Policy and Strategy Committee on 28 February 2014.Amendments issued since publicationDate Text affe

5、ctedCopyright British Standards Institution Provided by IHS under license with BSI - Uncontrolled Copy Not for ResaleNo reproduction or networking permitted without license from IHS-,-,-EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN ISO 11073-10103 December 2013 ICS 35.240.80 English Version H

6、ealth informatics - Point-of-care medical device communication - Part 10103: Nomenclature - Implantable device, cardiac (ISO/IEEE 11073-10103:2014) Informatique de sant - Communication entre dispositifs mdicaux sur le site des soins - Partie 10103: Nomenclature - Dispositif implantable, cardiaque (I

7、SO/IEEE 11073-10103:2014) This European Standard was approved by CEN on 14 December 2013. 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 li

8、sts and bibliographical references 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 unde

9、r 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 versions. CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, Former Y

10、ugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and United Kingdom. EUROPEAN COMMITTEE FOR STANDARDIZATION COMIT EURO

11、PEN DE NORMALISATION EUROPISCHES KOMITEE FR NORMUNG CEN-CENELEC Management Centre: Avenue Marnix 17, B-1000 Brussels 2013 CEN All rights of exploitation in any form and by any means reserved worldwide for CEN national Members. Ref. No. EN ISO 11073-10103:2013 ECopyright British Standards Institution

12、 Provided by IHS under license with BSI - Uncontrolled Copy Not for ResaleNo reproduction or networking permitted without license from IHS-,-,-BS EN ISO 11073-10103:2013EN ISO 11073-10103:2013 (E) 3 Foreword This document (EN ISO 11073-10103:2013) has been prepared by Technical Committee ISO/TC 215

13、“Health informatics” in collaboration 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 August 2014,

14、 and conflicting national standards shall be withdrawn 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. A

15、ccording to the CEN-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, Germ

16、any, Greece, Hungary, 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 11073-10103:2014 has been approved by CEN as EN

17、ISO 11073-10103:2013 without any modification. Copyright British Standards Institution Provided by IHS under license with BSI - Uncontrolled Copy Not for ResaleNo reproduction or networking permitted without license from IHS-,-,-BS EN ISO 11073-10103:2013ISO/IEEE 11073-10103:2014(E) IEEE 2012 All ri

18、ghts 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 a subj

19、ect 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 Commission (IE

20、C) 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, appr

21、oved 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 establishe

22、s 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 Standards ad

23、opted 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 subjec

24、t 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, for con

25、ducting 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 are rea

26、sonable 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. ISO/

27、IEEE 11073-10103 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 parallel with its approval by the ISO member bodies, under the “fast-track procedure” defined in th

28、e 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 informatics Personal h

29、ealth 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-care medical device commu

30、nication) Nomenclature Implantable device, cardiac Part 10201: (Point-of-care medical device communication) Domain information model Part 10404: Device specialization Pulse oximeter Copyright British Standards Institution Provided by IHS under license with BSI - Uncontrolled Copy Not for ResaleNo re

31、production or networking permitted without license from IHS-,-,-BS EN ISO 11073-10103:2013ISO/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 10

32、408: Device specialization 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 specia

33、lization Peak expiratory 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 communicati

34、on) 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: (Poin

35、t-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) Encod

36、ing rules Copyright British Standards Institution Provided by IHS under license with BSI - Uncontrolled Copy Not for ResaleNo reproduction or networking permitted without license from IHS-,-,-BS EN ISO 11073-10103:2013Part 10103: NomenclatureImplantable device, cardiac Sponsored by the IEEE 11073 St

37、andard 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 informaticsPoint-of-care medical device communication Authorized licensed use limited to: IEEE Standards Staff and authorized IEEE Sponsor B

38、allot Participants. Downloaded on May 28,2013 at 14:27:23 UTC from IEEE Xplore. Restrictions apply. Copyright British Standards Institution Provided by IHS under license with BSI - Uncontrolled Copy Not for ResaleNo reproduction or networking permitted without license from IHS-,-,-BS EN ISO 11073-10

39、103:2013Authorized 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. Copyright British Standards Institution Provided by IHS under license with BSI - Uncontrolled Copy Not for

40、 ResaleNo reproduction or networking permitted without license from IHS-,-,-BS EN ISO 11073-10103:2013IEEE Std 11073-10103TM-2012 Health informaticsPoint-of-care medical device communication Part 10103: NomenclatureImplantable device, cardiac Sponsor IEEE 11073TMStandards Committee of the IEEE Engin

41、eering in Medicine and Biology Society Approved 14 May 2012 IEEE-SA Standards Board 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. Copyright British Standards In

42、stitution Provided by IHS under license with BSI - Uncontrolled Copy Not for ResaleNo reproduction or networking permitted without license from IHS-,-,-BS EN ISO 11073-10103:2013Abstract: The base nomenclature provided in IEEE 11073 to support terminology for implantable cardiac devices is extended

43、in this standard. Devices within the scope of this nomenclature are implantable devices such as pacemakers, defibrillators, devices for cardiac resynchronization therapy, and implantable cardiac monitors. The discrete terms necessary to convey a clinically relevant summary of the information obtaine

44、d during a device interrogation are defined in this nomenclature. To improve workflow efficiencies, cardiology and electrophysiology practices require the management of summary interrogation information from all vendor devices and systems in a central system such as an Electronic Health Records (EHR

45、) system or a device clinic management system. To address this requirement, the Implantable Device, Cardiac (IDC) Nomenclature defines a standard-based terminology for device data. The nomenclature facilitates the transfer of data from the vendor proprietary systems to the clinic EHR or device clini

46、c management system. Keywords: cardiac resynchronization therapy (CRT), codes, follow-up, home monitoring, IEEE 11073-10103, implantable cardioverter defibrillator (ICD), implantable devices, medical device communication, nomenclature, pacemaker, remote follow-up, remote monitoring, terminology The

47、Institute of Electrical and Electronics Engineers, Inc. 3 Park Avenue, New York, NY 10016-5997, USA Copyright 2012 by The Institute of Electrical and Electronics Engineers, Inc. All rights reserved. Published 27 August 2012. Printed in the United States of America. IEEE is a registered trademark in

48、the U.S. Patent +1 978 750 8400. Permission to photocopy portions of any individual standard for educational classroom use can also be obtained through the Copyright Clearance Center. 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. Copyright British Standards Institution Provided by IHS under license with BSI - Uncontrolled Copy Not for ResaleNo reproduction or netw