Overview
ISO 22077-2:2023 - "Health informatics - Medical waveform format - Part 2: Electrocardiography" specifies how to apply the Medical waveform Format Encoding Rules (MFER) to describe standard electrocardiography (ECG) waveforms. It defines structured encoding for ECG recordings taken in physiological labs, hospital wards, clinics and primary care, enabling machine-readable, device‑neutral waveform storage and exchange. The standard is the first edition (2023) and replaces ISO/TS 22077-2:2015.
Key topics
- Scope of ECG types covered: encoding rules for 12‑lead, 15‑lead, 18‑lead, Cabrera lead, Nehb lead, Frank lead, XYZ lead and certain exercise tests recorded by electrocardiographs and MFER‑compatible patient monitors.
- Exclusions: Holter ECG, exercise stress ECG and real‑time ECG waveform encoding for physiological monitors are explicitly out of scope.
- Encoding format elements: primary description (sampling attributes, frame attributes, waveform and channel descriptions), data alignment, abstract waveform representation and lead calculation rules.
- Signal processing metadata: standardized description of filter‑processed data and filter use information to preserve provenance of processed waveforms.
- Measurement information: measurement time/classification, measurement values, observation/event classification, electrode condition, calibration waveform, artifact contamination and automatic interpretation codes (MFER interpretation and heartbeat codes).
- Normative and informative annexes: conformance statement, waveform alignment guidance, encoding of recognition points and measurement values, plus reference coding tables and bibliography.
Applications
ISO 22077-2:2023 supports practical interoperability and reuse of ECG data for:
- Medical device manufacturers - implement standardized waveform export for ECG machines and patient monitors.
- EHR/EMR and PACS vendors - ingest and archive ECG waveforms in a structured, interoperable format.
- Clinical sites and cardiology labs - ensure consistent recording metadata (filters, calibration, electrode status) for diagnostic accuracy and legal traceability.
- Health IT integrators and software developers - build viewers, analytics, and AI models that rely on well‑described, device‑neutral ECG inputs.
- Research and registries - harmonize multicentre ECG datasets for studies and quality assurance.
Related standards
- ISO 22077-1 (MFER encoding rules) - normative reference for format rules.
- Integrations recommended with HL7 CDA, XML and DICOM for richer clinical documents and imaging workflows.
Keywords: ISO 22077-2:2023, MFER, electrocardiography, ECG format, medical waveform format, health informatics, ECG interoperability, 12‑lead ECG, waveform encoding.
