Overview
EN ISO/IEEE 11073-10103:2025 (ISO/IEEE 11073-10103:2025) is the international nomenclature extension for implantable cardiac devices that supports device interoperability and standardized device data exchange. Building on the ISO/IEEE 11073 base nomenclature (10101:2020), this second edition defines the discrete terms needed to convey a clinically relevant summary of information obtained during a device interrogation of pacemakers, implantable cardioverter‑defibrillators (ICDs), cardiac resynchronization therapy (CRT) devices, and implantable cardiac monitors. The standard is intended to facilitate consistent transfer of device data into Electronic Health Records (EHRs), device clinic management systems and remote monitoring workflows.
Key topics and technical requirements
- Nomenclature extensions that add new terms, discriminators, co‑constraints and enumerations specific to implantable cardiac devices.
- Device and lead advisory information and inclusion of UDI (Unique Device Identifier) fields to support traceability.
- Battery and runtime data including remaining timeframes and dates for remaining useful life (RRT).
- CRT and pacing details such as multisite pacing status, LV–LV delay, and LV multisite pacing settings.
- Therapy and episode statistics for multiple tachycardia therapies (shocks, ATPs), episode‑related data, and statistics for ventricular rates during atrial tachyarrhythmias and mode switch events.
- Algorithm and setting terms: blanking/refractory settings, AF suppression, RV pace avoidance algorithms.
- Real‑time flags and metadata: episode‑in‑progress notifications, nomenclature versioning and vendor‑specific enumerations.
- Units and coding: updated units with UCUM and MDC references; clarified reference IDs and example values.
- Implementation guidance: example reports and implementation notes (Annex G) to aid integration.
Practical applications and typical users
This nomenclature supports practical workflows where standardized device data is required:
- Cardiology and electrophysiology clinics for device follow‑up, home monitoring and remote interrogation summaries.
- EHR and clinical IT vendors for consistent ingestion and display of implantable device data.
- Medical device manufacturers to encode device interrogation outputs in a standard, interoperable format.
- Hospital IT integrators and device clinic management systems to aggregate vendor‑specific data into centralized records.
- Health information exchange and standards implementers using ISO/IEEE 11073 together with HL7 or other messaging standards.
Related standards
- ISO/IEEE 11073-10101 (base nomenclature)
- Other IEEE 11073 components (e.g., ISO/IEEE 11073-10201)
- Health Level Seven (HL7) for message exchange and EHR integration
Keywords: ISO/IEEE 11073-10103, implantable cardiac devices, nomenclature, interoperability, pacemaker, ICD, CRT, EHR integration, device interrogation, UDI, HL7.