ISO/TS 22077-5:2021
(Main)Health informatics — Medical waveform format — Part 5: Neurophysiological signals
Health informatics — Medical waveform format — Part 5: Neurophysiological signals
This document specifies a heterogeneous format of neurophysiological waveform signals to support recording in a single persistent record package as well as interoperable exchange. The document focuses on electroencephalography (EEG) waveforms created during EEG examinations. Specific provision is made for sleep polysomnography examinations (PSG), brain death determination, evoked potentials (EP), and electromyography (EMG) studies. This document is intended for neurophysiology.
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TECHNICAL ISO/TS
SPECIFICATION 22077-5
First edition
2021-04
Health informatics — Medical
waveform format —
Part 5:
Neurophysiological signals
Reference number
©
ISO 2021
© ISO 2021
All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may
be reproduced or utilized otherwise in any form or by any means, electronic or mechanical, including photocopying, or posting
on the internet or an intranet, without prior written permission. Permission can be requested from either ISO at the address
below or ISO’s member body in the country of the requester.
ISO copyright office
CP 401 • Ch. de Blandonnet 8
CH-1214 Vernier, Geneva
Phone: +41 22 749 01 11
Email: copyright@iso.org
Website: www.iso.org
Published in Switzerland
ii © ISO 2021 – 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 . 1
5 General . 2
5.1 Overview of the rules . 2
5.2 Configuration of waveform data . 2
5.3 Time synchronization . 3
6 Waveform encoding . 5
6.1 General . 5
6.1.1 Application of EEG studies . 5
6.1.2 Full disclosure waveforms . 6
6.1.3 Intermittent record waveforms . 6
6.2 Waveform class . 7
6.2.1 General. 7
6.2.2 Waveform Class for EEG, PSG, EP, EMG . 7
6.3 Waveform attributes (lead names) . 9
6.3.1 Waveform code . 9
6.3.2 EEG .10
6.3.3 PSG, EOG, EMG, EP, RESP .10
6.3.4 ECG .11
6.4 Sampling attributes .12
6.4.1 General.12
6.4.2 MWF_IVL (0Bh): Sampling rate .12
6.4.3 MWF_SEN (0Ch): Sampling resolution .13
6.5 Frame attributes .13
6.6 Pointer .13
6.7 Filter .14
7 Event information .14
7.1 General .14
7.2 Measurement status – related events.15
Annex A (informative) MFER conformance statement .16
Annex B (informative) EEG electrode code .17
Annex C (informative) Example of waveform encoding .23
Bibliography .34
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
through ISO technical committees. Each member 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 Electrotechnical Commission (IEC) on all matters of
electrotechnical standardization.
The procedures used to develop this document and those intended for its further maintenance are
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).
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. ISO shall not be held responsible for identifying any or all such patent rights. Details of
any patent rights identified during the development of the document will be in the Introduction and/or
on the ISO list of patent declarations received (see www .iso .org/ patents).
Any trade name used in this document is information given for the convenience of users and does not
constitute an endorsement.
For an explanation of the voluntary nature of standards, the meaning of ISO specific terms and
expressions related to conformity assessment, as well as information about ISO's adherence to the
World Trade Organization (WTO) principles in the Technical Barriers to Trade (TBT), see www .iso .org/
iso/ foreword .html.
This document was prepared by Technical Committee ISO/TC 215, Health informatics.
A list of all parts in the ISO 22077 series can be found on the ISO website.
Any feedback or questions on this document should be directed to the user’s national standards body. A
complete listing of these bodies can be found at www .iso .org/ members .html.
iv © ISO 2021 – All rights reserved
Introduction
Neurophysiological signals are used to monitor and assess an individual’s brain activity for a wide array
of clinical examinations including sleep polysomnography (PSG), determination of brain death, evoked
potentials (EP), and electromyography (EMG).
Electroencephalography (EEG) is an electrophysiological monitoring method to record electrical
activity of the brain. It is typically non-invasive, with multiple electrodes placed along the scalp (see
Figures B.1 and B.2). Diagnostic applications generally focus on the spectral content of EEG, that is, the
type of neural oscillations (popularly called "brain waves") that can be observed in EEG signals. EEG
is most often used to diagnose epilepsy, which causes abnormalities in EEG readings. It is also used to
diagnose sleep disorders, coma, encephalopathies, and brain death.
PSG examinations include monitoring the condition of the body during sleep at night. Confirmed diagnosis
of sleeping disorders and sleeping respiratory disorders is supported by recording neurophysiological
signals through electrodes. By measuring brain waves, eye movements, electromyogram movements,
etc., the depth of sleep (sleep stage), quality, presence or absence of midwake arousal, respiration by
breathing, snoring, oxygen saturation, etc., can be assessed.
To correctly interpret neurophysiological changes, medical device systems need to capture
these data, along with additional waveforms such as the respiration, SpO2, EOG (eye movement).
Healthcare providers and clinical specialists who perform these examinations greatly benefit from
interoperability – having all the examination data recorded in a single standardized package or file that
can be safely and securely managed and exchanged.
The purpose of this document is to describe the heterogeneous neurophysiological waveforms and
related data that can be normalized to a standard semantic representation and format and persisted
in a single package. The specification also supports the time synchronization of these waveforms and
related parametric data so that the clinician receiving the data package is able to better assess the
patient’s condition throughout the examination period.
About Medical waveform Format Encoding Rules (MFER)
The MFER standards address several challenges that are not limited to either EEG waveforms or the
neurophysiological assessments that are the main subject of this document:
— Simple and easy implementation: application of MFER is very simple and is designed to facilitate
understanding, easy installation, trouble-shooting, and low implementation cost.
— Using with other appropriate standards: it is recommended that MFER only describes
medical waveforms. Other information can be described using appropriate standards such as
1) 2) 3)
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 data format instead of paper-based recording. For example, recorded ECG/EEG are
processed by filter, data alignment, and other parameters, so that the ECG waveform can be easily
displayed using an application viewer. However, it is not as useful for other purposes such as data
1) HL7 is the registered trademark of Health Level Seven International. This information is given for the convenience
of users of this document and does not constitute an endorsement by ISO of the product named.
2) DICOM is the registered trademark of the National Electrical Manufacturers Association for its standards
publications relating to digital communications of medical information. This information is given for the convenience
of users of this document and does not constitute an endorsement by ISO of the product named.
3) IEEE is a registered trademark of Institute of Electrical and Electronics Engin
...
TECHNICAL ISO/TS
SPECIFICATION 22077-5
First edition
2021-04
Health informatics — Medical
waveform format —
Part 5:
Neurophysiological signals
Reference number
©
ISO 2021
© ISO 2021
All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may
be reproduced or utilized otherwise in any form or by any means, electronic or mechanical, including photocopying, or posting
on the internet or an intranet, without prior written permission. Permission can be requested from either ISO at the address
below or ISO’s member body in the country of the requester.
ISO copyright office
CP 401 • Ch. de Blandonnet 8
CH-1214 Vernier, Geneva
Phone: +41 22 749 01 11
Email: copyright@iso.org
Website: www.iso.org
Published in Switzerland
ii © ISO 2021 – 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 . 1
5 General . 2
5.1 Overview of the rules . 2
5.2 Configuration of waveform data . 2
5.3 Time synchronization . 3
6 Waveform encoding . 5
6.1 General . 5
6.1.1 Application of EEG studies . 5
6.1.2 Full disclosure waveforms . 6
6.1.3 Intermittent record waveforms . 6
6.2 Waveform class . 7
6.2.1 General. 7
6.2.2 Waveform Class for EEG, PSG, EP, EMG . 7
6.3 Waveform attributes (lead names) . 9
6.3.1 Waveform code . 9
6.3.2 EEG .10
6.3.3 PSG, EOG, EMG, EP, RESP .10
6.3.4 ECG .11
6.4 Sampling attributes .12
6.4.1 General.12
6.4.2 MWF_IVL (0Bh): Sampling rate .12
6.4.3 MWF_SEN (0Ch): Sampling resolution .13
6.5 Frame attributes .13
6.6 Pointer .13
6.7 Filter .14
7 Event information .14
7.1 General .14
7.2 Measurement status – related events.15
Annex A (informative) MFER conformance statement .16
Annex B (informative) EEG electrode code .17
Annex C (informative) Example of waveform encoding .23
Bibliography .34
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
through ISO technical committees. Each member 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 Electrotechnical Commission (IEC) on all matters of
electrotechnical standardization.
The procedures used to develop this document and those intended for its further maintenance are
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).
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. ISO shall not be held responsible for identifying any or all such patent rights. Details of
any patent rights identified during the development of the document will be in the Introduction and/or
on the ISO list of patent declarations received (see www .iso .org/ patents).
Any trade name used in this document is information given for the convenience of users and does not
constitute an endorsement.
For an explanation of the voluntary nature of standards, the meaning of ISO specific terms and
expressions related to conformity assessment, as well as information about ISO's adherence to the
World Trade Organization (WTO) principles in the Technical Barriers to Trade (TBT), see www .iso .org/
iso/ foreword .html.
This document was prepared by Technical Committee ISO/TC 215, Health informatics.
A list of all parts in the ISO 22077 series can be found on the ISO website.
Any feedback or questions on this document should be directed to the user’s national standards body. A
complete listing of these bodies can be found at www .iso .org/ members .html.
iv © ISO 2021 – All rights reserved
Introduction
Neurophysiological signals are used to monitor and assess an individual’s brain activity for a wide array
of clinical examinations including sleep polysomnography (PSG), determination of brain death, evoked
potentials (EP), and electromyography (EMG).
Electroencephalography (EEG) is an electrophysiological monitoring method to record electrical
activity of the brain. It is typically non-invasive, with multiple electrodes placed along the scalp (see
Figures B.1 and B.2). Diagnostic applications generally focus on the spectral content of EEG, that is, the
type of neural oscillations (popularly called "brain waves") that can be observed in EEG signals. EEG
is most often used to diagnose epilepsy, which causes abnormalities in EEG readings. It is also used to
diagnose sleep disorders, coma, encephalopathies, and brain death.
PSG examinations include monitoring the condition of the body during sleep at night. Confirmed diagnosis
of sleeping disorders and sleeping respiratory disorders is supported by recording neurophysiological
signals through electrodes. By measuring brain waves, eye movements, electromyogram movements,
etc., the depth of sleep (sleep stage), quality, presence or absence of midwake arousal, respiration by
breathing, snoring, oxygen saturation, etc., can be assessed.
To correctly interpret neurophysiological changes, medical device systems need to capture
these data, along with additional waveforms such as the respiration, SpO2, EOG (eye movement).
Healthcare providers and clinical specialists who perform these examinations greatly benefit from
interoperability – having all the examination data recorded in a single standardized package or file that
can be safely and securely managed and exchanged.
The purpose of this document is to describe the heterogeneous neurophysiological waveforms and
related data that can be normalized to a standard semantic representation and format and persisted
in a single package. The specification also supports the time synchronization of these waveforms and
related parametric data so that the clinician receiving the data package is able to better assess the
patient’s condition throughout the examination period.
About Medical waveform Format Encoding Rules (MFER)
The MFER standards address several challenges that are not limited to either EEG waveforms or the
neurophysiological assessments that are the main subject of this document:
— Simple and easy implementation: application of MFER is very simple and is designed to facilitate
understanding, easy installation, trouble-shooting, and low implementation cost.
— Using with other appropriate standards: it is recommended that MFER only describes
medical waveforms. Other information can be described using appropriate standards such as
1) 2) 3)
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 data format instead of paper-based recording. For example, recorded ECG/EEG are
processed by filter, data alignment, and other parameters, so that the ECG waveform can be easily
displayed using an application viewer. However, it is not as useful for other purposes such as data
1) HL7 is the registered trademark of Health Level Seven International. This information is given for the convenience
of users of this document and does not constitute an endorsement by ISO of the product named.
2) DICOM is the registered trademark of the National Electrical Manufacturers Association for its standards
publications relating to digital communications of medical information. This information is given for the convenience
of users of this document and does not constitute an endorsement by ISO of the product named.
3) IEEE is a registered trademark of Institute of Electrical and Electronics Engin
...
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