ISO/TS 22077-2:2015

TECHNICAL ISO/TS
SPECIFICATION 22077-2
First edition
2015-08-01
Health informatics — Medical
waveform format —
Part 2:
Electrocardiography
Informatique de santé — Forme d’onde médicale —
Partie 2: Electrocardiographie
Reference number
©
ISO 2015
© ISO 2015, Published in Switzerland
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ii © ISO 2015 – All rights reserved

Contents Page
Foreword .iv
Introduction .v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Symbols and abbreviated terms . 2
5 Encoding format . 2
5.1 Primary description. 2
5.1.1 Sampling attributes . 3
5.1.2 Frame attributes . 3
5.1.3 Waveform . 4
5.1.4 Channel . 6
5.2 Data alignment . 7
5.3 Abstract waveform. 7
5.4 Lead calculation . 8
5.5 Filter information . 9
5.5.1 Description of filter-processed data . 9
5.5.2 Description of filter use information . 9
5.6 Unique identifier . 9
6 Measurement information .10
6.1 Measurement date/time .10
6.2 Measurement time (classification point) .10
6.3 Measurement value .11
6.4 Measurement information classification .11
6.4.1 Observation event .11
6.4.2 Waveform ancillary information .11
6.4.3 Recording/display condition . .11
6.5 Power supply frequency .12
6.6 Electrode condition .12
6.7 Calibration waveform .12
6.8 Artefact contamination .12
6.9 Automatic interpretation code, etc. .13
6.9.1 MFER interpretation code and heart beat code encoding rules .13
6.10 Patient information .14
6.10.1 Patient name .14
6.10.2 Patient ID .14
6.10.3 Age and date of birth .14
6.10.4 Gender .14
6.11 Comment .15
Annex A (informative) MFER Conformance statement .16
Annex B (informative) Waveform alignment .17
Annex C (informative) Encoding of waveform recognition point and measurement values .26
Annex D (informative) Reference table of coding scheme .33
Annex E (informative) Waveform verification rule between ECG provider and user .37
Bibliography .38
Foreword
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
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electrotechnical standardization.
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described in the ISO/IEC Directives, Part 1. In particular the different approval criteria needed for the
different types of ISO documents should be noted. This document was drafted in accordance with the
editorial rules of the ISO/IEC Directives, Part 2 (see www.iso.org/directives).
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The committee responsible for this document is ISO/TC 215, Health informatics.
ISO/TS 22077 consists of the following parts, under the general title Health informatics — Medical
waveform format:
— Part 1: Encoding rules
— Part 2: Electrocardiography
— Part 3: Long term electrocardiography
iv © ISO 2015 – All rights reserved

Introduction
The standard 12-lead electrocardiogram (ECG) is one of the most widely used medical waveforms in
clinical sites. In particular, the increased usage of electronic medical records provides the environment
in which these ECGs can be accurately utilized; however, it is essential that to address the therapeutic
requirements, ECG use is not constrained to specific machine types and manufacturers. Furthermore,
there is great interest in the various kinds of patient information contained in ECGs that are extensively
studied and shared between health care providers.
This Technical Specification defines the detailed rules for electrocardiogram waveform format
that is encoded according to the medical waveform format encoding rules (MFER). In addition to
electrocardiogram waveform format encoding, there are rules for other waveforms such as long-term
ECG (Holter ECG), stress ECG, etc. that are contained in other MFER technical specifications. Please
refer to those specifications for additional information.
About MFER
Medical waveforms such as electrocardiogram, electroencephalogram, and blood pressure waveforms
are widely utilized in clinical areas such as physiological examinations, electronic medical records,
medical investigations, research, education, etc. Medical waveforms are used in various combinations
and document types according to the intended diagnostic purpose. For example, ECG waveforms are
utilized extensively in the clinical arena, with resting 12-lead ECG being used the most. A cardiologist
makes diagnoses using 10 s to 15 s ECG waveform measurements; however, longer periods are
sometimes required to recognize patient heart conditions such as arrhythmia. Also, there are many
other methods using ECG such as Holter ECG, physiologic monitoring ECG, stress ECG, intracardiac ECG,
VCG, EEG with ECG, blood pressure with ECG, PSG, etc. MFER can describe not only ECG for physiological
examinations conducted in ICU and operating room acute care contexts, but also EEG, respiration
waveform, and pulse.
Simple and easy
MFER is a specialized representation for medical waveforms that removes unnecessary coded elements
(“tags”) for waveform description. For example, a standard 12-lead ECG can be described simply only
using a common sampling condition and the lead condition, making waveform synchronization and
correct lead calculation much easier.
Using with other appropriate standards
It is recommended that MFER only describes medical waveforms. Other information can be described
using appropriate standards such as HL7, DICOM, IEEE, etc. For example, clinical reports that include
patient demographics, order information, medication, etc. are supported in other standards such as
HL7 Clinical Document Architecture (CDA); by including references to MFER information in these
documents, implementation for message exchange, networking, database management that includes
waveform information becomes simple and easy.
Separation between supplier and consumer of medical waveforms
The MFER specification concentrates on da
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