ISO 22077-2-2023 PDF

Full title and description

Health informatics — Medical waveform format — Part 2: Electrocardiography. This International Standard specifies the application of the Medical Waveform Format Encoding Rules (MFER) to represent standard electrocardiography (ECG) waveforms and their associated metadata for use in clinical and healthcare information systems.

Abstract

This document defines how MFER encoding rules are applied to describe standard ECG recordings (for example 12‑lead, 15‑lead, 18‑lead, Cabrera, Frank, XYZ and similar lead configurations) produced by electrocardiographs and patient monitors used in physiological laboratories, wards, clinics and primary care. It explicitly excludes long‑term Holter recordings, exercise stress real‑time monitor encoding and other waveform types out of scope for this part.

General information

• Status: Published
• Publication date: August 2023
• Publisher: International Organization for Standardization (ISO)
• ICS / categories: 35.240.80 (Health informatics — healthcare information systems)
• Edition / version: Edition 1 (ISO 22077-2:2023)
• Number of pages: 34 (ISO published document)

Scope

Specifies the application of MFER encoding rules to standard electrocardiography waveforms recorded in clinical settings. The scope covers representation of multi‑lead standard ECGs measured by electrocardiographs and compatible patient monitors and provides rules for waveform samples, lead identification, timing, annotations and related metadata needed for storage and exchange. The standard excludes Holter/long‑term ambulatory recordings and certain real‑time monitor encodings, which are addressed in other parts of the series.

Key topics and requirements

• Application of MFER encoding rules to ECG waveform data (file structure and record encoding).
• Support for multiple lead systems (12‑lead, 15‑lead, 18‑lead, Cabrera, Frank, XYZ, etc.).
• Specification of sampling, resolution and timing metadata to preserve diagnostic fidelity.
• Standardized annotations and markers for events, measurements and interpretation aids.
• Rules for lead identification, patient and recording metadata to enable interoperable exchange.
• Conformance and validation requirements for implementers to ensure compatibility with MFER consumers.

Typical use and users

Used by medical device manufacturers (electrocardiographs, patient monitors), healthcare IT vendors (EHR/EMR systems, cardiology information systems), clinical engineering teams, standards implementers, and integrators working on waveform data exchange and archiving. It is also referenced by clinical informaticians and regulatory bodies concerned with interoperable ECG data formats.

Related standards

Part of the ISO 22077 series (Medical waveform format / MFER). Related documents include ISO 22077-1 (MFER encoding rules / framework) and ISO 22077-3 (Long‑term electrocardiography). The 2023 edition of Part 2 replaces the earlier ISO/TS 22077-2:2015 technical specification.

Keywords

MFER, medical waveform format, ECG, electrocardiography, health informatics, waveform encoding, interoperability, ISO 22077, ECG metadata

FAQ

Q: What is this standard?

A: ISO 22077-2:2023 is an International Standard that specifies how to encode and exchange standard electrocardiography waveform data using the Medical Waveform Format Encoding Rules (MFER).

Q: What does it cover?

A: It covers the representation of standard clinical ECG recordings (e.g., 12‑lead and other multi‑lead configurations), associated timing and metadata, annotations and conformance rules for storage and exchange. It does not cover long‑term Holter recordings or some real‑time monitor encodings (addressed in other parts of ISO 22077).

Q: Who typically uses it?

A: Medical device manufacturers, healthcare software and EHR vendors, clinical engineering and interoperability specialists, and standards implementers who need a consistent, interoperable ECG waveform format.

Q: Is it current or superseded?

A: ISO 22077-2:2023 is the current published version (issued August 2023). It supersedes the earlier technical specification ISO/TS 22077-2:2015.

Q: Is it part of a series?

A: Yes — it is Part 2 of the ISO 22077 series (Medical waveform format / MFER). Other parts include ISO 22077-1 (encoding rules/framework) and ISO 22077-3 (long‑term electrocardiography), among related documents in the series.

Q: What are the key keywords?

A: MFER, ECG, electrocardiography, medical waveform, interoperability, health informatics, waveform encoding, ISO 22077.