National foreword

This British Standard is the UK implementation of ISO 22077‑2:2023. It supersedes PD ISO/TS 22077‑2:2015, which is withdrawn.

The UK participation in its preparation was entrusted to Technical Committee IST/35, Health informatics.

A list of organizations represented on this committee can be obtained on request to its committee manager.

Contractual and legal considerations

This publication has been prepared in good faith, however no representation, warranty, assurance or undertaking (express or implied) is or will be made, and no responsibility or liability is or will be accepted by BSI in relation to the adequacy, accuracy, completeness or reasonableness of this publication. All and any such responsibility and liability is expressly disclaimed to the full extent permitted by the law.

This publication is provided as is, and is to be used at the recipient’s own risk.

The recipient is advised to consider seeking professional guidance with respect to its use of this publication.

This publication is not intended to constitute a contract. Users are responsible for its correct application.

Compliance with a British Standard cannot confer immunity from legal obligations.

This British Standard was published under the authority of the Standards Policy and Strategy Committee on 30 September 2023.

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 document 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).

ISO draws attention to the possibility that the implementation of this document may involve the use of (a) patent(s). ISO takes no position concerning the evidence, validity or applicability of any claimed patent rights in respect thereof. As of the date of publication of this document, ISO had not received notice of (a) patent(s) which may be required to implement this document. However, implementers are cautioned that this may not represent the latest information, which may be obtained from the patent database available at www.iso.org/patents. ISO shall not be held responsible for identifying any or all such patent rights.

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 215, Health informatics.

This first edition of ISO 22077‑2 cancels and replaces ISO/TS 22077‑2:2015, which has been technically revised.

The main changes are as follows:

clarified references in the text for all figures and tables;
updated clause 3;
corrected Figure 4, Figure C.1 and Figure C.4;
deleted the description of "Unique identifier", "Measurement date/time", "Patient information", and "Comment" that are described in ISO 22077‑1;
added and changed the description for some items of Annex B.
deleted Annex E;

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.

Introduction

The standard 12-lead electrocardiography (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, to address the therapeutic requirements, ECG use should not be constrained to specific machine types and manufacturers. Furthermore, the various kinds of patient information contained in ECGs that are extensively studied and shared between health care providers.

This document defines the detailed rules for the electrocardiography waveform format that is encoded according to the medical waveform format encoding rules (MFER). Rules for other waveforms such as long-term ECG (Holter ECG), stress ECG, etc. are contained in other MFER documents.

About MFER

Medical waveforms such as ECG, electroencephalography (EEG), 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 typically makes diagnoses using 10 s to 15 s ECG waveform measurements; however, longer periods are sometimes required to recognize heart conditions such as arrhythmia. Also, there are many other methods using ECG such as Holter ECG, physiologic monitoring ECG, stress ECG, intracardiac ECG, vectorcardiography (VCG), EEG with ECG, blood pressure with ECG, sleep polysomnography (PSG), etc. MFER can describe not only ECG for physiological examinations conducted in intensive care unit (ICU) and operating room acute care contexts, but also EEG, respiration waveforms, and pulse.

Implementation

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.

Use with other appropriate standards

It is recommended that MFER only describes medical waveforms. Other information can be described using appropriate standards including HL7®1 CDA, XML, and DICOM®2. 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 is processed by filter, data alignment and other parameters, so that the ECG waveform can be easily displayed using an application viewer. However, the ECG recordings displayed as images are not as useful for other purposes such as data processing for research investigations. A design goal of MFER is that a waveform is described in raw format with as complete as possible recording detail. When the waveform is used, appropriate processing of the data is supported such as filtering, view alignment, etc. In this way, the medical waveform described in MFER can be used for multiple purposes.

Product capabilities are not limited

Standards often support only a minimum set of requirements, so the expansion of product features can be greatly limited. MFER can describe medical waveform information without constraining the potential features of a product. Also, medical waveform display must be very flexible, and thus MFER has mechanisms supporting not only a machine-readable coded system for abstract data, but also human-readable representations.

The MFER specification supports both present and future product implementations. MFER supports the translation of stored waveform data that was encoded using other standards, enabling harmonization and interoperability. This capability supports not only existing waveform format standards, but it can also be extended to support future formats as well.

1 Scope

This document defines the application of medical waveform format encoding rules (MFER) to describe standard electrocardiography waveforms measured in physiological laboratories, hospital wards, clinics, and primary care medical checkups. It covers electrocardiography such as 12-lead, 15-lead, 18-lead, Cabrera lead, Nehb lead, Frank lead, XYZ lead, and exercise tests that are measured by inspection equipment such as electrocardiographs and patient monitors that are compatible with MFER.

Medical waveforms that are not in the scope of this document include Holter ECG, exercise stress ECG, and real-time ECG waveform encoding used for physiological monitors.

2 Normative references

3 Terms, definitions and abbreviated terms

3.1 Terms and definitions

3.2 Abbreviated terms

4 Encoding format

4.1 Primary description

4.2 Data alignment

4.3 Abstract waveform

4.4 Lead calculation

4.5 Filter information

5 Measurement information

5.1 General

5.2 Measurement time (classification point)

5.3 Measurement value

5.4 Measurement information classification

5.5 Power supply frequency

5.6 Electrode condition

5.7 Calibration waveform

5.8 Artefact contamination

5.9 Automatic interpretation code, etc.

Bibliography

BS ISO 22077-2:2023

Health informatics. Medical waveform format - Electrocardiography

Current

Published:

30 Sep 2023