1、BRITISH STANDARDBS EN 1064:2005Incorporating amendment no. 1Health informatics Standard communication protocol Computer-assisted electrocardiographyThe European Standard EN 1064:2005, with the incorporation of A1:2007, has the status of a British StandardICS 35.240.80g49g50g3g38g50g51g60g44g49g42g3g
2、58g44g55g43g50g56g55g3g37g54g44g3g51g40g53g48g44g54g54g44g50g49g3g40g59g38g40g51g55g3g36g54g3g51g40g53g48g44g55g55g40g39g3g37g60g3g38g50g51g60g53g44g42g43g55g3g47g36g58BS EN 1064:2005This British Standard was published under the authority of the Standards Policy and Strategy Committee on 22 March 20
3、05 BSI 2007ISBN 0 580 45655 2National forewordThis British Standard was published by BSI. It is the UK implementation of EN 1064:2005, incorporating amendment A1:2007. It supersedes DD ENV 1064:1994 which is withdrawn.The start and finish of text introduced or altered by amendment is indicated in th
4、e text by tags !“. Tags indicating changes to CEN text carry the number of the CEN amendment. For example, text altered by CEN amendment A1 is indicated by !“.The UK participation in its preparation was entrusted to Technical Committee IST/35, Health informatics.A list of organizations represented o
5、n this committee can be obtained on request to its secretary.This publication does not purport to include all the necessary provisions of a contract. Users are responsible for its correct application.Compliance with a British Standard cannot confer immunity from legal obligations.Amendments issued s
6、ince publicationAmd. No. Date Comments17087 31 May 2007 See national forewordEUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN 1064:2005+A1 March 2007 ICS 35.240.80 Supersedes EN 1064:2005English Version Health informatics - Standard communication protocol - Computer-assisted electrocardiography
7、Informatique de sant - Protocole de communication standard - Electrocardiographie assiste par ordinateur Medizinische Informatik - Standardkommunikationsprotokoll- Computergesttzte Elektrokardiographie This European Standard was approved by CEN on 17 December 2004 and includes Amendment 1 approved b
8、y CEN on 15 January 2007. 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 lists and bibliographical references concerning such national stan
9、dards may be obtained on application to the CEN 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 under the responsibility of a CEN member into its own language and notified
10、to the CEN Management Centre has the same status as the official versions. CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta,
11、Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom. EUROPEAN COMMITTEE FOR STANDARDIZATION COMIT EUROPEN DE NORMALISATION EUROPISCHES KOMITEE FR NORMUNG Management Centre: rue de Stassart, 36 B-1050 Brussels 2007 CEN All rights of exploi
12、tation in any form and by any means reserved worldwide for CEN national Members. Ref. No. EN 1064:2005+A1:2007: EEN 1064:2005+A1:2007 (E) 2 Contents Page Foreword4 Introduction .5 1 Scope 8 2 Normative references 8 3 Terms and definitions .8 3.1 Terms specific to this document8 3.2 Other technical t
13、erms related to this document.10 4 Abbreviations.10 5 Definition of the data contents and format .11 5.1 General considerations.11 5.2 Specifications for the data structure .13 5.3 Pointer section Section 0.16 5.4 Header information Patient data / ECG acquisition data Section 118 5.5 Huffman tables
14、Section 2.39 5.6 ECG lead definition Section 341 5.7 QRS locations, reference beat subtraction zones and protected areas Section 4 47 5.8 Encoded type 0 reference beat data Section 5 49 5.9 Rhythm data Section 6 .52 5.10 Global measurements Section 7 .53 5.11 Storage of full text interpretive statem
15、ents Section 8 59 5.12 Storing manufacturer specific interpretive statements and data related to the overreading trail Section 9 61 5.13 Lead measurement block Section 10 .61 5.14 Storage of the universal ECG interpretive statement codes Section 11 64 6 Minimum requirements for encoding and compress
16、ion of the ECG signal data67 6.1 Scope and field of application67 6.2 Introduction67 6.3 ECG compression methodology68 6.4 Main results from investigations on ECG data compression in the SCP-ECG project69 6.5 Minimum requirements for ECG data compression.70 Annex A (normative) Encoding of alphanumer
17、ic ECG data in a multilingual environment.72 Annex B (normative) Definition of compliance with the SCP ECG standard 88 Annex C (normative) Methodology and conformance testing of the recommended ECG signal compression technique 97 EN 1064:2005+A1:2007 (E) 3 Annex D (informative) Definition of a minim
18、um set of control and query messages for the interchange of ECG data.133 Annex E (informative) Standard low-level ECG-Cart to host protocol.148 Annex F (informative) Universal ECG interpretation statements codes .161 Annex G (informative) Glossary 184 Bibliography186 EN 1064:2005+A1:2007 (E) 4 Forew
19、ord This document (EN 1064:2005+A1:2007) has been prepared by 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 la
20、test by September 2007, and conflicting national standards shall be withdrawn at the latest by September 2007. This document includes Amendment 1, approved by CEN on 2007-01-15. The start and finish of text introduced or altered by amendment is indicated in the text by tags ! “. This document supers
21、edes !EN 1064:2005“. According to the CEN/CENELEC Internal Regulations, the national standards organizations of the following countries are bound to implement this European Standard: Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Icel
22、and, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom. EN 1064:2005+A1:2007 (E) 5 Introduction The electrocardiogram (ECG) is a recording of voltage changes transmitted to the body
23、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, extracardiac tissues may intervene and influence the ECG. El
24、ectrocardiography 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 100 million standard ECGs are recorded yearly in the Eur
25、opean Community (EC) for routine diagnostic and screening purposes at an estimated cost of more than 1,2 billion ECU per year. Almost all newer electrocardiographs nowadays use digital recording, interpretation and communication techniques. These stand-alone, microcomputer based machines can be conn
26、ected 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 restricted in their options by incompatible technical feat
27、ures 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 different end-users who for different purposes (suppor
28、t 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 stretches from departments of cardiology in hospit
29、als, to general practitioners in primary care and health care centers. In life-threatening acute myocardial infarction, ECGs are being used in ambulances by paramedical personnel to assess the necessity for administering thrombolytic agents, with long-distance monitoring whenever possible. To enable
30、 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 document is to specify a data format for transferring
31、ECG reports and data from any vendors computerized ECG recorder to any others vendor central ECG management system. The same standard should also allow standardized transfer of digitised ECG data and results between various computer systems. Under the standard communication protocol (SCP) the conten
32、ts 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 remains with the user/purchaser. The following possible
33、 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 contents and format of the waveform data, measurement
34、s, and the interpretive statements meet his or her specific needs. If more than one type of ECG devices and/or database management systems are interconnected, the user is also advised to verify with the manufacturers that the data from different systems are compatible with each other and with the us
35、ers needs. EN 1064:2005+A1:2007 (E) 6 In order to understand this document, the reader needs some basic understanding of electrocardiology, electrocardiography and signal processing. This document relates to the conventional recording of the electrocardiogram, i.e. the so-called standard 12-lead ele
36、ctrocardiogram and the vectorcardiogram (VCG). Initially, the electric connections used for recording the ECG were made to the limbs only. These connections to the right arm (RA), left arm (LA), left leg (LL) and right leg (RL) were introduced by Einthoven. The electrical variations detected by thes
37、e 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 right arm. The unipolar electrocardiographic leads (aVR, aVL, aVF and the precordial leads V1 to V6) were intr
38、oduced 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 contraction. The “augmented“ limb lead potentials are recorded with reference to the average potential of (L+F)
39、, (R+F) and (L+R) respectively. The unipolar chest leads are recorded with reference to the average potential of (RA+RL+LL)/3 which is called the Wilson “central terminal“ (CT). In vectorcardiography recordings are made of three mutually perpendicular leads, running parallel to one of the rectilinea
40、r 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 centers, so-called body surface maps are obtained by placing many (from 24 to 124 or even more) closely spaced electrodes around
41、the torso. This document has not been designed to handle exchange of such recordings, although future extensions could be made to this end. The standard has also not been designed to exchange specialized recordings of intracardiac potentials or of the so-called Holter or other long-term ECG recordin
42、gs made for monitoring cardiac rhythm. This document also does not address exercise ECG recordings. ECG computer processing can be reduced to 3 principal stages: 1) data acquisition, encoding, transmission and storage; 2) pattern recognition and feature extraction, i.e. ECG measurement; 3) diagnosti
43、c classification. In each of these stages there are important needs for standardization and quality assurance testing. The scope of the document is confined to the first of these three stages. The various data sections that shall be transmitted by means of the standard ECG communications protocol ar
44、e defined in Clause 5 of this document. Minimum requirements for data encoding and compression are defined in Clause 6. !The compliance categories defined in Annex B provide users and manufacturers of ECG devices and/or systems with a relatively simple codification of SCP-ECG related features and in
45、formation content that may be provided by a specific device. Two Data Format Categories have been defined based on information content as in the following table: Data Format Categories for Compliance Specifications Category Data Sections Required Content Description I 0, 1, 21, 3, 6, (7)2, (8)2, (10
46、)2Demographics, and ECG rhythm data (uncompressed or with lossless compression) II 0, 1, 21, 3, 4, 5, 6, (7)2, (8)2, (10)2Demographics, ECG rhythm data (uncompressed, with lossless compression or with high compression), and reference beats EN 1064:2005+A1:2007 (E) 7 NOTE 1 Square brackets . indicate
47、 that data section 2 is required if Huffman encoding has been used. NOTE 2 Parentheses (.) indicate that these data sections are optional for export. A further category may be added in future versions in order to fulfil the specific needs of ECG devices used in other applications (such as telemedici
48、ne or homecare). All devices stating a SCP-ECG Data Format Category shall import at minimum data sections 0, 1, 3, 6, 7, and 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
49、data blocks that have been defined in the document. Reserved, unspecified and undefined fields, bytes or data blocks shall not be used for manufacturer specific data. For a particular device, a SCP-ECG compliance statement lists Data Format Category(ies) for export (i.e. acquiring and making available a SCP-ECG record) and import (i.e. accepting, and making available to a user, a SCP-ECG record). A device may also state its ability to transfer (i.e. making available a SCP-ECG record without changing its data format, for example, expor
