Overview
ISO/IEEE 11073-10103:2025 - "Health informatics - Device interoperability - Part 10103: Nomenclature, implantable device, cardiac" defines a standardized terminology for implantable cardiac devices (pacemakers, implantable cardioverter‑defibrillators (ICDs), cardiac resynchronization therapy (CRT) devices, and implantable cardiac monitors). Building on the base nomenclature in ISO/IEEE 11073-10101:2020, this second edition provides discrete terms to convey a clinically relevant summary of interrogation data so vendor systems can reliably exchange device information with EHRs and device-clinic management systems.
Key topics and requirements
- Nomenclature extensions for implantable cardiac devices to standardize coded device interrogation output.
- New and updated items introduced in this edition, including:
- Device and lead advisory information and UDI (unique device identifier) support
- Battery remaining timeframes and date of remaining runtime (RRT)
- CRT and LV multisite pacing status and settings (e.g., LVLV delay)
- Blanking and refractory settings, AF suppression and RV pace‑avoidance algorithm settings
- Therapy and episode statistics: multiple tachycardia therapy counts (shocks, ATPs), episode-related metrics, ventricular rates during atrial tachyarrhythmias and mode-switch
- Episode-in-progress flag notifications, nomenclature versioning, and vendor‑specific enumerations
- Units of measure updated with UCUM and MDC references and term codes to ensure consistent quantitative reporting.
- Implementation guidance provided in Annexes (example reports and implementation notes) to support practical adoption.
- Designed to be usable with other IEEE 11073 components (e.g., ISO/IEEE 11073-10201) or with other healthcare messaging standards such as HL7.
Applications
- Standardizing data transfer from proprietary device vendor systems to:
- Electronic Health Records (EHRs) for consolidated patient device histories
- Device clinic management and follow-up systems for remote monitoring and workflow efficiency
- Clinical decision support and population health analytics that rely on consistent device terminology
- Facilitating remote follow-up, home monitoring, and multi-vendor device aggregation in cardiology and electrophysiology practices.
Who should use this standard
- Medical device manufacturers (pacemakers, ICDs, CRT systems, implantable monitors)
- EHR and clinical systems integrators
- Cardiology/electrophysiology clinics and device clinics
- Health IT vendors, interoperability engineers, and standards implementers
- Regulators and healthcare organizations assessing device-data exchange
Related standards
- ISO/IEEE 11073-10101:2020 (base nomenclature)
- ISO/IEEE 11073-10201 and other IEEE 11073 parts
- HL7 messaging standards for healthcare data exchange
Keywords: implantable cardiac devices, nomenclature, device interoperability, ISO/IEEE 11073, pacemaker, ICD, CRT, implantable cardiac monitor, EHR integration, UDI, remote monitoring.