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

Status
Published
Current Stage
6060 - Definitive text made available (DAV) - Publishing
Due Date
12-Aug-2020
Completion Date
12-Aug-2020

RELATIONS

Buy Standard

Standard
EN 1064:2020
English language
240 pages
sale 10% off
Preview
sale 10% off
Preview

e-Library read for
1 day

Standards Content (sample)

SLOVENSKI STANDARD
SIST EN 1064:2020
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
SIST EN 1064:2020 en,fr,de

2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

---------------------- Page: 1 ----------------------
SIST EN 1064:2020
---------------------- Page: 2 ----------------------
SIST EN 1064:2020
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.
---------------------- Page: 3 ----------------------
SIST EN 1064:2020
EN 1064:2020 (E)
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

---------------------- Page: 4 ----------------------
SIST EN 1064:2020
EN 1064:2020 (E)
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.
---------------------- Page: 5 ----------------------
SIST EN 1064:2020
EN 1064:2020 (E)
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.
---------------------- Page: 6 ----------------------
SIST EN 1064:2020
EN 1064:2020 (E)

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 their specific needs. If more than one type of ECG

device and/or ECG management system is interconnected, the user is also advised to verify with the

manufacturers that the data from different systems and devices are compatible with each other and with

the user’s needs.

In order to understand this document, the reader needs some basic knowledge of electrocardiology,

electrocardiography and signal processing.

This document not only relates to the conventional recording of the electrocardiogram, i.e. the so-called

standard 12-lead electrocardiogram and the vectorcardiogram (VCG), but also to other types of ECG such

as Holter ECG, physiologic monitoring ECG, stress ECG, intracardiac ECG, home care ECG monitoring and

wearable self-care ECG devices. 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) and left leg (LL) were introduced

by Einthoven. The electrical variations detected by these electrode connections 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 (VR, VL, VF 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 contraction. The “augmented” limb lead potentials (aVR, aVL, aVF) are

recorded with reference to the average potential of (L+F), (R+F) and (L+R) respectively, where R, L and

F refer to the RA, LA and LL electrodes. 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 from three mutually orthogonal 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 12-Lead stress ECG recordings, the limb

electrodes are placed on the torso to reduce limb movement artefacts. The same electrode positions apply

to some Holter, emergency and home care recordings, both to limit movement artefacts and undressing.

In some research centres, so-called body surface maps are obtained by placing many (from 24 to 124 or

even more) closely spaced electrodes around 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 (electrograms) recorded

in the EP (Electrophysiology) laboratories or by cardiac implantable electronic devices (CIED), viz

pacemakers, implantable cardioverter-defibrillators (ICDs) and cardiac resynchronization therapy (CRT)

devices, although it could also be used to this intent.
ECG computer processing can be reduced to 3 principal stages:
1) data acquisition, encoding, transmission and storage;
---------------------- Page: 7 ----------------------
SIST EN 1064:2020
EN 1064:2020 (E)
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 document is confined to the first of these three stages. Quality assurance of ECG

measurement and diagnostic classification have been addressed by the CSE Working Party (see [32] and

[44] to [50]) and to some extent by IEC 60601-2-25:2011 [4]. The latter also addresses the issue of

quality assurance testing of the signal acquisition hardware and filtering.

The various data sections that shall be transmitted by means of the standard ECG communications

protocol are defined in Clause 5 of this document.

The selection and definition of ECG specific high-level syntaxes and query languages for transfer of

messages and data between devices or between devices and hosts or host-to-hosts, using for example

Bluetooth, TCP/IP, FTP, USB, Filesystem, HL7, etc., are beyond the scope of this document.

The main goal of the SCP-ECG standard is to address ECG data and related metadata structuring,

semantics and syntax, with the objective of facilitating interoperability and thus to support and promote

the exchange of the relevant information for ECG diagnosis. Indeed, as recommended by the

ACC/AHA/ACP-ASIM task force: “Electrocardiogram readers should understand the importance of

comparing a current tracing to previous tracings in order to make correct diagnoses. All abnormal

tracings should be compared with available previous tracings. The accuracy of some diagnoses may be

considerably enhanced by reviewing previous tracings.” [33]. It is thus of utmost importance to provide

a storage format enabling any device or computer program performing the analysis and interpretation of

a current ECG to perform a reliable re-analysis of the previous ECGs. For assessing serial changes between

ECG measurements it is necessary that the measurements are computed in the same way on each

recording in order to avoid any bias.

The binary encoding of ECG data within SCP-ECG and the included content self-control capabilities allow

for an efficient encoding, an encapsulation of all ECG-related parameters, and a small memory footprint

compliant with mHealth scenarios for an early detection of cardiac diseases, anywhere and anytime [31],

[39]. These features not only provide an advantage in data transmission and archiving, but also when the

data need to be encrypted (for protecting the data and the confidentiality), or signed (protection against

changes).

The present version of the SCP-ECG standard has been significantly amended, with the objective to

provide means to support the storage and interchange of almost all existing ECG recording modalities,

processing results, annotations and diagnoses, as well as precisely defined metadata enabling the

harmonization with other standards in health informatics. The main changes are summarized hereafter.

The ECG data and related metadata addressed in this document are now structured into 18 sections.

Sections 0 to 11 already existed in the previous versions of SCP-ECG and, although they have been

significantly updated, they remain almost backwards compatible with SCP-ECG V1.x and V2.x, except for

other than UTF-8 text strings encoding and beat subtraction or bimodal compression schemes which are

no longer supported. Starting with SCP-ECG V3.0, only lossless compression (difference and Huffman

encoding) of the long-term rhythm data (section 6) and of the reference beat type 0 data (section 5) are

now allowed. In addition, to simplify encoding, the present standard recommends to store all ECG signal

data uncompressed as a series of fixed length, signed integers and to reserve difference data calculation

and Huffman encoding for mobile and/or wearable devices, when they are intended to be used in poorly

served areas with limited wireless connectivity such as GPRS, where significant lossless data reduction

strategies are still of importance. Converting legacy SCP-ECG V1.x and V2.x files into SCP-ECG V3.0

compliant files would thus only require to convert non UTF-8 text strings into UTF-8 and to store ECG

2 Impacted by IEC/CD 80601-2-86 under development
---------------------- Page: 8 ----------------------
SIST EN 1064:2020
EN 1064:2020 (E)

signal data, if any, uncompressed. Sections 12 to 18, which are new, have been introduced to support the

storage of continuous, long-term ECG recordings, of selected sequences of stress tests, drug trials and

protocol-based ECG recordings, and the related metadata, measurements and annotations

All over the document, emphasis has been put on cross-referencing and providing a semantic mapping

between the terminology and the methodologies used in SCP-ECG and the ISO/IEEE 11073-10102

Annotated ECG (aECG) [9] and 11073-10101 Nomenclature (Vital signs) [8] standards and on levering

the ambiguities and inaccuracies of some of these other than SCP-ECG standards.

In section 1, SCP-ECG Drugs coding (Tag 10), Medical History codes (Tag 32) and Electrode configuration

Codes (Tag 33) have been significantly updated to take account of the evolution of the medical needs, and

two new tags have been introduced, respectively aimed at describing Implanted Cardiac Devices (Tag 36,

based on the NASPE/BPEG coding systems [28], [29]) and at specifying drugs according to the WHO

Anatomical Therapeutic Chemical Classification System (ATC code [43], Tag 37).

Section 4, formerly used to store QRS locations to allow beat subtraction for computing a “residual signal”,

has been deprecated and shall no longer be implemented. But Section 4 is still mentioned in the present

document to support decoding and conversion of legacy SCP-ECG version 1.x and 2.x files into SCP-ECG

version V3.0 files.

The global and per-lead measurements sections have been significantly extended. The terminology used

and the measurements and annotations provided have been harmonized with the aECG standard [9] and

with the different recommendations and consensus papers (viz the need for introducing new

measurements describing the early repolarization patterns) found in the scientific literature.

All measurements have been precisely defined, with the aim of unifying the way ECG measurements are

performed and of serving as a reference for scientific work. Manufacturers using methods other than

those recommended in SCP-ECG Version 3.0 are requested to specify the method they are using in the

physician's guide.

Section 11, which aims to contain the most recent interpretation and overreading data, now allows three

different coding schemes (in addition to free text): (1) according to the Universal Statement Codes and

Coding Rules defined in Annex B: (2) based on the categorized AHA statement codes [21]; (3) according

to the CDISC (Controlled Terminology. Clinical Data Interchange Standards Consortium) code [30].

The three different coding schemes may coexist, i.e. an interpretive statement encoded according to the

SCP-ECG Universal Statement Codes and Coding Rules may concomitantly also be encoded according to

the AHA and/or the CDISC code specifications.

Emphasis has also been put on extending and harmonizing the SCP-ECG Universal Statement Codes

defined in Annex A with the AHA and CDISC statement codes and specifications, and with aECG [9] and

DICOM [19].

Starting with version V3.0, in addition to the short duration resting ECG (section 6) and the corresponding

type 0 reference beat (section 5), the standard now provides means of storing long-term ECG rhythm data

in section 12, e.g. up to 40 days continuous recording of 3-Lead ECG signals sampled at 200 samples/sec

with a 16 bit resolution, in section 14 several selected short to medium duration ECG sequences, and, in

section 13, the related metadata and reference beats (or pointers to selected reference beats). These two

additional sections have been included to support protocol-based ECG recordings, viz stress tests and

drug trials procedures.

The format of section 12 is very similar to the ISHNE format [26]. In order to preserve random access to

the record’s segments, no compression or encoding is allowed in this section.

In addition to the full set of global measurements (section 7) and the per-lead measurements (section 10)

of the type 0 reference beat, starting with version V3.0 the standard now allows the storage, in section

15, of several pre-defined global and per-lead beat measurements and annotations, for all or for only

some computed or selected beats of the analysed signals (long-term and/or long-term ECGs stored in

sections 12 and 14 and/or in section 6). The beats may have been selected one by one by a physician or

---------------------- Page: 9 ----------------------
SIST EN 1064:2020
EN 1064:2020 (E)

by a beat typing algorithm (reference beats of different types, etc.), or may refer to the entire set of beats

from one or more selected time windows within the long-term ECG stored in section 12 or in the long-

term ECGs stored in sections 6 or 14.

In another scenario, one may choose to select and store the measurements and annotations for K

preselected, not necessarily consecutive beats, in as much Measurement Blocks (MB) as there are

selected beats, for thorough QT studies for example. To facilitate comparison with reference beats

measurements, the standard also allows saving, in separate MBs, the measurements and annotations

performed on the reference beats stored in sections 5 & 13.

Section 16 provides a solution for storing a different set of measurements and annotations than those

stored in section 15 and is thus complementary to section 15. Its structure and format are much the same

as for section 15, except that there is no provision for specifying analysis time windows and that there

are no reserved fields for systematically storing the PP and RR intervals (the latter can nevertheless be

stored, if need be, as optional additional measurements).

Section 16 is the preferred section for storing selected ECG beat measurements and annotations, if no

beat-by-beat measurements and annotations are required (section 15 is not present).

Section 17 has been designed to include support for pre-defining and storing (much like the way used for

storing beat-by-beat ECG measurements in section 15) large sets of global and/or per-lead spike

measurements and annotations, spike-by-spike in one or more spike measurements array(s), one

measurement array per analyzed ECG sequence (full long-term ECG record, selected ECG sequence) or

reference beat.

Section 18 “Additional ECG annotations” provides a solution for storing any type of manually or

automatically produced annotation which has not been stored in a systematic way in sections 7, 8, 10, 11

and 15 to 17, viz the onset (and end) of a bigeminal rhythm or atrial fibrillation, the identification of a

pacemaker spike that was not listed in section 17, measurements that were not foreseen in sections 15

and 16 (or a few measurements like QT intervals in drug studies in case neither section 15 nor section 16

have been implemented), manual annotation of complex cases with different types of aberrant QRS

complexes (LBBB aberrancy, etc.) and P waves (AV dissociation, etc.), noise annotations in a given lead,

etc.
---------------------- Page: 10 ----------------------
SIST EN 1064:2020
EN 1064:2020 (E)
1 Scope

This document specifies the common conventions required for the interchange of specific

...

Questions, Comments and Discussion

Ask us and Technical Secretary will try to provide an answer. You can facilitate discussion about the standard in here.