BS ISO 11073-91064-2009 Health informatics - Standard communication protocol - Computer-assisted electrocardiography《健康信息学 标准通信协议 计算机辅助心电图仪》.pdf

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1、BS ISO11073-91064:2009ICS 35.240.80NO COPYING WITHOUT BSI PERMISSION EXCEPT AS PERMITTED BY COPYRIGHT LAWBRITISH STANDARDHealth informatics StandardcommunicationprotocolPart 91064: Computer-assistedelectrocardiographyThis British Standardwas published under theauthority of the StandardsPolicy and St

2、rategyCommittee on 31 October2009 BSI 2009ISBN 978 0 580 59515 8Amendments/corrigenda issued since publicationDate CommentsBS ISO 11073-91064:2009National forewordThis British Standard is the UK implementation of ISO11073-91064:2009.The UK participation in its preparation was entrusted to TechnicalC

3、ommittee IST/35, Health informatics.A list of organizations represented on this committee can be obtained onrequest to its secretary.This publication does not purport to include all the necessary provisionsof a contract. Users are responsible for its correct application.Compliance with a British Sta

4、ndard cannot confer immunityfrom legal obligations.BS ISO 11073-91064:2009Reference numberISO 11073-91064:2009(E)ISO 2009INTERNATIONAL STANDARD ISO11073-91064First edition2009-05-01Health informatics Standard communication protocol Part 91064: Computer-assisted electrocardiography Informatique de sa

5、nt Communication entre dispositifs mdicaux sur le site des soins Partie 91064: Protocole de communication standard pour llectrocardiographie assiste par ordinateur BS ISO 11073-91064:2009ISO 11073-91064:2009(E) PDF disclaimer This PDF file may contain embedded typefaces. In accordance with Adobes li

6、censing policy, this file may be printed or viewed but shall not be edited unless the typefaces which are embedded are licensed to and installed on the computer performing the editing. In downloading this file, parties accept therein the responsibility of not infringing Adobes licensing policy. The

7、ISO Central Secretariat accepts no liability in this area. Adobe is a trademark of Adobe Systems Incorporated. Details of the software products used to create this PDF file can be found in the General Info relative to the file; the PDF-creation parameters were optimized for printing. Every care has

8、been taken to ensure that the file is suitable for use by ISO member bodies. In the unlikely event that a problem relating to it is found, please inform the Central Secretariat at the address given below. COPYRIGHT PROTECTED DOCUMENT ISO 2009 All rights reserved. Unless otherwise specified, no part

9、of this publication may be reproduced or utilized in any form or by any means, electronic or mechanical, including photocopying and microfilm, without permission in writing from either ISO at the address below or ISOs member body in the country of the requester. ISO copyright office Case postale 56

10、CH-1211 Geneva 20 Tel. + 41 22 749 01 11 Fax + 41 22 749 09 47 E-mail copyrightiso.org Web www.iso.org Published in Switzerland ii ISO 2009 All rights reservedBS ISO 11073-91064:2009ISO 11073-91064:2009(E) ISO 2009 All rights reserved iiiContents Page Foreword iv Introduction v 1 Scope . 1 2 Normati

11、ve references . 1 3 Terms and definitions. 1 4 Abbreviations 3 5 Definition of the data contents and format 4 5.1 General considerations 4 5.2 Specifications for the data structure 5 5.3 Pointer section Section 0 8 5.4 Header information Patient data/ECG acquisition data Section 1. 10 5.5 Huffman ta

12、bles Section 2 23 5.6 ECG lead definition Section 3. 24 5.7 QRS locations, reference beat subtraction zones and protected areas Section 4 . 30 5.8 Encoded type 0 reference beat data Section 5 . 32 5.9 Rhythm data Section 6 34 5.10 Global measurements Section 7 36 5.11 Storage of full text interpreti

13、ve statements Section 8 . 41 5.12 Storing manufacturer specific interpretive statements and data related to the overreading trail Section 9 . 43 5.13 Lead measurement block Section 10.43 5.14 Storage of the universal ECG interpretive statement codes Section 11 46 6 Minimum requirements for encoding

14、and compression of the ECG signal data. 48 6.1 Scope and field of application. 48 6.2 Introduction . 48 6.3 ECG compression methodology. 49 6.4 Main results from investigations on ECG data compression in the SCP-ECG Project. 50 6.5 Minimum requirements for ECG data compression 51 Annex A (normative)

15、 Encoding of alphanumeric ECG data in a multilingual environment . 53 Annex B (normative) Definition of compliance with the SCP ECG standard. 66 Annex C (normative) Methodology and conformance testing of the recommended ECG signal compression technique 74 Annex D (informative) Definition of a minimu

16、m set of control and query messages for the interchange of ECG data 106 Annex E (informative) Standard low-level ECG-Cart to host protocol 121 Annex F (informative) Universal ECG interpretation statements codes. 132 Annex G (informative) Glossary 154 Bibliography . 156 BS ISO 11073-91064:2009ISO 110

17、73-91064:2009(E) iv ISO 2009 All rights reservedForeword 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 m

18、ember 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 part in the work. ISO collaborates closely with the International

19、Electrotechnical Commission (IEC) on all matters of electrotechnical standardization. International Standards are drafted in accordance with the rules given in the ISO/IEC Directives, Part 2. The main task of technical committees is to prepare International Standards. Draft International Standards a

20、dopted 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 drawn to the possibility that some of the elements of this document may be the subject of p

21、atent rights. ISO shall not be held responsible for identifying any or all such patent rights. ISO 11073-91064 was prepared by Technical Committee ISO/TC 215, Health informatics. BS ISO 11073-91064:2009ISO 11073-91064:2009(E) ISO 2009 All rights reserved vIntroduction The electrocardiogram (ECG) is

22、a recording of voltage changes transmitted to the body surface by electrical events in the heart muscle, providing direct evidence of cardiac rhythm and conduction, and indirect evidence of certain aspects of myocardial anatomy, blood supply and function. During its propagation to the surface, extra

23、cardiac tissues may intervene and influence the ECG. Electrocardiography has been used for many years as a key, non-invasive method in the diagnosis and early detection of coronary heart disease, which is the leading cause of mortality in western countries. In 1993, it was estimated that more than 1

24、00 million standard ECGs are recorded yearly in the European Community (EC) for routine diagnostic and screening purposes at an estimated cost of more than 1,2 billion per year. Almost all newer electrocardiographs nowadays use digital recording, interpretation and communication techniques. These st

25、and-alone, microcomputer based machines can be connected to each other, and to larger minicomputer-based management servers for long-term storage and serial comparison. To this end, various manufacturers have used different techniques. It is in the general public interest for users not to be restric

26、ted in their options by incompatible technical features and services of different systems. ECG processing is increasingly being integrated with various other data processing in health care. This evolution shall have considerable impact on the storage and communication of ECG data. There are many dif

27、ferent end-users who for different purposes (support of patient care, management, research and education) want to obtain a copy of the signal data, of the interpretive report and/or measurement results. Being one of the very first systems for medical decision support, computerized ECG interpretation

28、 stretches from departments of cardiology in hospitals, to general practitioners in primary care and health care centres. In life-threatening acute myocardial infarction, ECGs are being used in ambulances by paramedical personnel to assess the necessity for administering thrombolytic agents, with lo

29、ng-distance monitoring whenever possible. To enable the exchange of information between various systems it was of utmost importance that a standard communications protocol for computer-aided electrocardiography (SCP-ECG) had to be established, as defined in this document. The primary aim of this doc

30、ument is to specify a data format for transferring ECG reports and data from any vendors computerized ECG recorder to any other vendors central ECG management system. The same standard should also allow standardized transfer of digitized ECG data and results between various computer systems. Under t

31、he standard communication protocol (SCP) the contents and format of the ECG waveform data and the measurements from ECG devices of different manufacturers are not expected to be identical. As a result, the determination of the suitability of a device and/or system for any particular application rema

32、ins with the user/purchaser. The following possible uses of ECG records require special attention: serial comparison of ECGs and interpretations; plot formats of ECGs; maintaining audit trail of edits; bi-directional communication and remote query. The user is cautioned to make sure that the data co

33、ntents and format of the waveform data, measurements, and the interpretive statements meet his or her specific needs. If more than one type of ECG device and/or database management system are interconnected, the user is also advised to verify with the manufacturers that the data from different syste

34、ms are compatible with each other and with the users needs. BS ISO 11073-91064:2009ISO 11073-91064:2009(E) vi ISO 2009 All rights reservedIn order to understand this document, the reader needs some basic understanding of electrocardiology, electrocardiography and signal processing. This part of ISO

35、11073 relates to the conventional recording of the electrocardiogram, i.e. the so-called standard 12-lead electrocardiogram and the vectorcardiogram (VCG). Initially, the electrical connections used for recording the ECG were made to the limbs only. These connections to the right arm (RA), left arm

36、(LA), left leg (LL) and right leg (RL) were introduced by Einthoven. The electrical variations detected by these leads are algebraically combined to form the bipolar leads I, II and III. Lead I, for example, records the difference between the voltages of the electrodes placed on the left arm and the

37、 right arm. The unipolar electrocardiographic leads (aVR, aVL, aVF and the precordial leads V1 to V6) were introduced much later, starting in 1933. In these leads, potentials are recorded at one location with respect to a level which does not vary significantly in electrical activity during cardiac

38、contraction. The “augmented” limb lead potentials are recorded with reference to the average potential of (L+F), (R+F) and (L+R) respectively. The unipolar chest leads are recorded with reference to the average potential of ( )RA+RL+LL3which is called the Wilson “central terminal” (CT). In vectorcar

39、diography, recordings are made of three mutually perpendicular leads, running parallel to one of the rectilinear coordinate axes of the body. The axes are the X-axis going right to left, the Y-axis with a top to bottom orientation and the Z or front to back axis. In some research centres, so-called

40、body surface maps are obtained by placing many (from 24 to 124 or even more) closely-spaced electrodes around the torso. This part of ISO 11073 has not been designed to handle exchanges of such recordings, although future extensions could be made to this end. This part of ISO 11073 has also not been

41、 designed to exchange specialized recordings of intracardiac potentials or of the so-called Holter or other long-term ECG recordings made for monitoring cardiac rhythm. This part of ISO 11073 also does not address exercise ECG recordings. ECG computer processing can be reduced to three principal sta

42、ges: 1) data acquisition, encoding, transmission and storage; 2) pattern recognition and feature extraction, i.e. ECG measurement; 3) diagnostic classification. In each of these stages there are important needs for standardization and quality assurance testing. The scope of this part of ISO 11073 is

43、 confined to the first of these three stages. The various data sections that shall be transmitted by means of the standard ECG communications protocol are defined in Clause 5. Minimum requirements for data encoding and compression are defined in Clause 6. The compliance categories defined in Annex B

44、 provide users and manufacturers of ECG devices and/or systems with a relatively simple codification of SCP-ECG related features and information content that may be provided by a specific device. Two data format categories have been defined based on information content as in Table 1. Table 1 Data fo

45、rmat categories for compliance specifications Category Data sections required Content description I 0, 1, 2, 3, 6, (7), (8), (10) Demographics, and ECG rhythm data (uncompressed or with lossless compression) II 0, 1, 2, 3, 4, 5, 6, (7), (8), (10) Demographics, ECG rhythm data (uncompressed, with los

46、sless compression or with high compression), and reference beats NOTE 1 Square brackets indicate that data section 2 is required if Huffman encoding has been used. NOTE 2 Parentheses ( ) indicate that these data sections are optional for export. BS ISO 11073-91064:2009ISO 11073-91064:2009(E) ISO 200

47、9 All rights reserved viiA further category may be added in future versions in order to fulfil the specific needs of ECG devices used in other applications (such as telemedicine or homecare). All devices stating an SCP-ECG data format category shall import at minimum data sections 0, 1, 3, 6, 7 and

48、8. All categories may have additional sections added (e.g. 9, 10, 11). Manufacturer-specific data shall be optionally included only in manufacturer-specific fields, bytes and data blocks that have been defined in the document. Reserved, unspecified and undefined fields, bytes or data blocks shall no

49、t be used for manufacturer-specific data. For a particular device, an SCP-ECG compliance statement lists data format category(ies) for export (i.e. acquiring and making available an SCP-ECG record) and import (i.e. accepting, and making available to a user, an SCP-ECG record). A device may also state its ability to transfer (i.e. making available an SCP-ECG record without changing its data format, for example, exporting a record that was previously imported). (These terms are precisely defined in