ISO 41064:2023

Overview

ISO 41064:2023 - Health informatics - Standard communication protocol - Computer-assisted electrocardiography (SCP‑ECG) defines a standardized ECG data interchange format for digital electrocardiography. It specifies the content, structure and encoding required to exchange patient demographics, recording conditions, ECG waveform data, metadata, measurements, annotations and interpretation results between ECG devices, ECG management systems, cloud repositories and electronic health records.

Key topics and technical requirements

• Data structure and sections: formalized file layout including pointer/index sections, patient/header metadata, lead definitions, encoded beats, rhythm segments and multiple measurement/annotation repositories (e.g., Sections 0–18).
• Supported ECG types: 12‑lead, 15‑lead, 18‑lead, Cabrera, Nehb, Frank, XYZ, Holter, exercise/stress ECGs and intracardiac electrograms from implantable devices (note: intra-cardiac/extra-cardiac mapping and real‑time monitor encoding are out of scope).
• Measurements & annotations: global and per‑lead measurements, beat‑by‑beat and selected‑beat data, pacemaker spike annotations, long‑term rhythm storage and protocol-based test metadata.
• Encoding & interoperability rules: UTF‑8 text encoding required; legacy SCP‑ECG compatibility supported; deprecated legacy compression schemes (beat subtraction, bimodal) and updated compression guidance (Annex D).
• Interpretation coding: storage of free‑text and standardized interpretive statements, including AHA/CDISC‑aligned coding schemes and universal ECG interpretation codes (Annex B).
• Normative and informative annexes: implementation recommendations, compliance definitions, compression methodology, cross‑references to other ECG/health informatics standards, glossary and revision history.

Applications and who uses it

ISO 41064:2023 is intended for:

• ECG device manufacturers (electrocardiographs, patient monitors, wearables, implantable devices) to enable vendor-neutral exports.
• Hospital IT, PACS and EMR vendors for reliable ingest, archiving and serial comparison of ECGs.
• ECG management system developers and cloud providers for secure storage, retrieval and analytics.
• Clinicians and cardiology departments for consistent interpretive reports and longitudinal patient monitoring.
• Clinical trial teams and research groups for standardized ECG data capture in stress tests and drug trials.
• Telecardiology and EMS/ambulance systems integrating remote ECG transmission.

Related standards

ISO 41064:2023 is harmonized with ISO/IEEE 11073 (Annotated ECG aECG and Nomenclature) and references other ECG and health informatics standards (see Annex E). For implementers, Annex F offers practical guidance and Annex C defines compliance criteria.

Keywords: ISO 41064:2023, SCP‑ECG, ECG data interchange, ECG metadata, ECG waveform, ECG interoperability, digital ECG, health informatics.