EN 1064:2020
(Main)Health informatics - Standard communication protocol - Computer-assisted electrocardiography
Health informatics - Standard communication protocol - Computer-assisted electrocardiography
This document specifies the common conventions required for the cart-to-host as well as cart-to-cart interchange of specific patient data (demographic, recording, ...), ECG signal data, ECG measurement and ECG interpretation results.
This document specifies the content and structure of the information which is to be interchanged between digital ECG carts and computer ECG management systems, as well as other computer systems where ECG data can be stored
Medizinische Informatik - Standardkommunikationsprotokoll - Computergestützte Elektrokardiographie
Informatique de santé - Protocole de communication standard - Électrocardiographie assistée par ordinateur
Le présent document spécifie les conventions communes nécessaires à l'échange de données spécifiques sur les patients (données démographiques, conditions d'enregistrement, etc.), de données et métadonnées relatives aux signaux ECG, des mesures et annotations d'ECG et des résultats de l'interprétation des ECG.
Le présent document spécifie le contenu et la structure des informations qui doivent être échangées entre les électrocardiographes/dispositifs ECG numériques et les systèmes de gestion informatique des ECG, ainsi qu'avec les autres systèmes informatiques ou d'information (Cloud, etc.) susceptibles de stocker des données ECG.
Le présent document définit la manière de décrire et de coder les formes d'onde d'électrocardiogramme standard et à moyen ou long terme, mesurées dans des laboratoires de physiologie, dans des services hospitaliers, dans des cliniques et dans le cadre d'examens médicaux primaires, de soins ambulatoires et de soins à domicile. Il couvre différents types d'électrocardiogrammes, notamment les ECG à 12 dérivations, à 15 dérivations, à 18 dérivations, à dérivations de Cabrera, à dérivations de Nehb, à dérivations de Frank et à dérivations XYZ, et les ECG Holter et à l'effort, qui sont enregistrés, mesurés et analysés par des équipements de type électrocardiographes, moniteurs pour patients et dispositifs portatifs. Il traite également des électrogrammes intracardiaques enregistrés par des dispositifs implantables, ainsi que des résultats d'analyse des systèmes et logiciels d'analyse et d'interprétation des ECG compatibles avec le SCP-ECG.
Le codage et l'analyse des formes d'onde ECG en temps réel utilisés pour les moniteurs physiologiques, de même que la cartographie ECG intracardiaque ou extra-cardiaque, comptent parmi les formes d'onde et les données ECG qui ne relèvent pas du domaine d'application de la présente spécification technique.
Zdravstvena informatika - Standardni komunikacijski protokol - Računalniško podprta elektrokardiografija
General Information
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Standards Content (Sample)
SLOVENSKI STANDARD
01-november-2020
Nadomešča:
SIST EN 1064:2005+A1:2008
Zdravstvena informatika - Standardni komunikacijski protokol - Računalniško
podprta elektrokardiografija
Health informatics - Standard communication protocol - Computer-assisted
electrocardiography
Medizinische Informatik - Standardkommunikationsprotokoll - Computergestützte
Elektrokardiographie; Englische Fassung EN 1064:2005+A1:2007
Informatique de Santé - Protocole de Communication Standard pour
L'Electrocardiographie Assistée par Ordinateur
Ta slovenski standard je istoveten z: EN 1064:2020
ICS:
35.240.80 Uporabniške rešitve IT v IT applications in health care
zdravstveni tehniki technology
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
EN 1064
EUROPEAN STANDARD
NORME EUROPÉENNE
August 2020
EUROPÄISCHE NORM
ICS 35.240.80 Supersedes EN 1064:2005+A1:2007
English Version
Health informatics - Standard communication protocol -
Computer-assisted electrocardiography
Informatique de santé - Protocole de communication Medizinische Informatik -
standard - Électrocardiographie assistée par Standardkommunikationsprotokoll -
ordinateur Computergestützte Elektrokardiographie
This European Standard was approved by CEN on 22 June 2020.
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 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 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 versions.
CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia,
Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway,
Poland, Portugal, Republic of North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and
United Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION
EUROPÄISCHES KOMITEE FÜR NORMUNG
CEN-CENELEC Management Centre: Rue de la Science 23, B-1040 Brussels
© 2020 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN 1064:2020 E
worldwide for CEN national Members.
Contents Page
European foreword . 3
Introduction . 4
1 Scope . 9
2 Normative references . 9
3 Terms and definitions . 9
4 Symbols and abbreviated terms . 11
5 Definition of the data contents and format . 12
5.1 General considerations . 12
5.2 Specifications for the data structure . 13
5.3 Pointer section – Section 0 . 18
5.4 Header information - Patient data / ECG metadata – Section 1 . 20
5.5 Huffman tables – Section 2 . 36
5.6 ECG leads definition – Section 3 . 38
5.7 Reserved for legacy SCP-ECG versions – Section 4 . 47
5.8 Encoded type 0 reference beat data – Section 5 . 49
5.9 Short-term ECG Rhythm data – Section 6. 52
5.10 Global ECG measurements – Section 7 . 54
5.11 Storage of full text interpretive statements – Section 8 . 68
5.12 Storage of manufacturer specific interpretive statements and data related to the
overreading trail – Section 9 . 69
5.13 Per-lead ECG measurements – Section 10 . 69
5.14 Storage of the universal ECG interpretive statement codes – Section 11 . 78
5.15 Long-term ECG rhythm data – Section 12 . 82
5.16 Stress tests, Drug trials and Protocol based ECG recordings Metadata – Section 13 . 87
5.17 Selected ECG Sequences Repository – Section 14 . 98
5.18 Beat-by-Beat ECG measurements and annotations – Section 15 . 102
5.19 Selected ECG beats measurements and annotations – Section 16 . 117
5.20 Pacemaker Spikes measurements and annotations – Section 17 . 126
5.21 Additional ECG annotations – Section 18 . 140
Annex A (normative) Supplementary information and additional encoding specifications . 147
Annex B (informative) Universal ECG interpretation statements codes . 155
Annex C (informative) Definition of compliance with the SCP ECG standard . 181
Annex D (Informative) Methodology of the recommended ECG signal compression technique . 190
Annex E (informative) Cross-references to other ECG standards . 226
Annex F (informative) Implementation Recommendations . 229
Annex G (informative) Glossary . 231
Annex H (informative) Revision History . 233
Bibliography . 236
European foreword
This document (EN 1064:2020) 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 latest by February 2021, and conflicting national standards shall
be withdrawn at the latest by February 2021.
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. CEN shall not be held responsible for identifying any or all such patent rights.
This document supersedes EN 1064:2005+A1:2007.
According to the CEN-CENELEC Internal Regulations, the national standards organisations of the
following countries are bound to implement this European Standard: Austria, Belgium, Bulgaria, Croatia,
Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland,
Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Republic of North
Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the United
Kingdom.
Introduction
The electrocardiogram (ECG) is 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, extracardiac tissues may intervene and influence the ECG morphology.
Electrocardiography has been used for many years, and is increasingly used as a key, non-invasive and
low cost method in the diagnosis and early detection of coronary heart disease, which is the leading cause
of mortality worldwide [56] . Of the 56.9 million global deaths in 2016, 40.5 million (71.3 %) were due
to non-communicable diseases (NCDs) and 17.9 million (31 %) were due to cardiovascular diseases
(CVDs). Out of these 17.9 million cardiovascular deaths, ischaemic heart disease was responsible for 9.4
million and strokes were responsible for 5.8 million deaths. More than 3 million of these 17.9 million CVD
deaths occurred before the age of 60. The percentage of premature deaths from CVDs ranges from 8.8 %
in high-income countries to 26 % in low-income countries [56].
In 2018, it was estimated that, worldwide, approximatively 3 million ECGs are recorded every day [41].
The Mayo Clinic, for example, nowadays performs about 240,000 standard ECG recordings per year [57].
According to Research And Markets, the Global Electrocardiography Devices (ECG) Market accounted for
$5,122 million in 2018 and is expected to reach $9,738 million by 2027 [58]. The factors driving this
market include the increasing geriatric population, rising incidences of lifestyle diseases, technological
advancements in diagnostic ECG devices, and high growth rate in developing countries.
Almost all newer electrocardiographs nowadays use digital recording, interpretation and communication
techniques, and there is an increasing number of portable and even wearable (mobile) ECG devices that
are now used instead of the traditional ECG cart. These stand-alone, microprocessor based machines and
devices can be connected to each other, to a host computer, to the internet or to a hospital information
system for reporting, long-term storage in the Medical Electronic Record 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
features and services of different systems and devices. ECG processing is increasingly being integrated
with various other types of data processing in health care. This evolution will have considerable impact
on the storage and communication of ECG data. There are many different end-users who for different
purposes (support of patient care, management, drug trials and/or drug 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 ever developed systems for medical decision support, computerized
ECG interpretation stretches from departments of cardiology in hospitals, to general practitioners in
primary care and health care centres and to home care. In life-threatening acute myocardial infarction,
ECGs are now used in ambulances by paramedical personnel to assess the necessity for administering
thrombolytic agents or to alert cathlabs to prepare for a coronary intervention, with long-distance
monitoring whenever possible, and in self-care situations to detect ischemia or life threatening
arrhythmias as early as possible [31].
To facilitate the exchange of information between various systems, it was of utmost importance that a
standard communications protocol for computer-aided electrocardiography (SCP-ECG) was established,
as defined in this document. Its aim is to specify a data format for transferring ECG signals, metadata and
reports from any vendor's computerized ECG device to any other's vendor central ECG management
system. The same standard should also allow standardized transfer of digitised ECG data and results
between various computer and information systems, Electronic Medical Records, and ECG data
repositories.
Figures in square brackets refer to the Bibliography.
Under this standard communications protocol (SCP-ECG), the contents and format of the ECG waveform
data, metadata 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 uses of ECG records require special
attention:
— serial comparison of ECGs and interpretations;
— printout formats of ECGs;
— maintaining an audit trail of edits and annotations;
— integration into an electronic medical record;
— integration into clinical information systems and data repositories.
The users are cautioned to make sure that the data contents and format of the waveform data, metadata,
measurements, and the interpretive statements meet th
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