ISO 14708-2:2019

Overview - ISO 14708-2:2019 (Cardiac pacemakers)

ISO 14708-2:2019 is the international standard that defines particular requirements for active implantable medical devices intended to treat bradyarrhythmias, including devices that provide cardiac resynchronization therapy (CRT‑P). It supplements ISO 14708-1 and specifies type tests to be carried out on device samples (implantable pulse generators, leads, accessories and certain non‑implantable parts) to demonstrate compliance with safety and performance expectations. The standard covers traditional endocardial/epicardial lead systems and notes the emergence of leadless technologies, leaving adaptations for manufacturers to implement.

Key technical topics and requirements

• Scope and device types: Bradyarrhythmia pacemakers and CRT‑P devices; exclusions/links to ISO 14708‑6 for tachyarrhythmia functions.
• Type testing and measurements: Methods to measure pulse amplitude, pulse duration, pulse rate/interval, sensing, pacing refractory periods and lead pacing impedance.
• Packaging and marking: Requirements for sales and sterile packaging, labelling and device markings that affect safe use and traceability.
• Protection and safety: Protection from electrical harm, heat, ionizing radiation, mechanical forces, electrostatic discharge, atmospheric pressure and electromagnetic (non‑ionizing) fields.
• Non‑implantable parts & software: Requirements for programmers, accessories, software usability, data security and prevention of harm due to unauthorized tampering.
• Risk management and usability: General risk controls, misconnection prevention and documentation requirements.
• Annexes and test references: Annex C provides a coding system for pacing modes; Annex D defines pulse forms and measurement reference points.
• Notable updates in 2019 edition: Added requirements for congestive heart failure devices (CRT‑P), nomenclature for >2 channel devices, revised pulse measurement methods, removal of input‑impedance measurement, and new temporary surface‑temperature exposure criteria (outer surface > 39 °C).

Practical applications - who uses this standard

• Medical device manufacturers: Design, validation and type testing of pacemakers, CRT‑P systems, leads and related accessories.
• Test laboratories and QA teams: Implementing measurement methods and type tests to demonstrate conformity.
• Regulatory and compliance specialists / notified bodies: Preparing technical files and assessing compliance for market approval.
• Design engineers and clinical safety officers: Ensuring device protection (EMC, thermal, mechanical) and safe software/user interfaces.
• Procurement and hospital biomedical engineers: Understanding markings, packaging and accessory compatibility.

Related standards

• ISO 14708-1 (general requirements for active implantable medical devices)
• ISO 14708-6 (tachyarrhythmia devices)
• ISO 14117:2019 (nomenclature and lead/device interactions referenced in this edition)

This standard is essential for ensuring the safety, reliability and regulatory readiness of cardiac pacemakers and CRT‑P devices. Keywords: ISO 14708-2:2019, cardiac pacemaker standard, active implantable medical devices, pacemaker testing, CRT‑P, bradyarrhythmia, implantable pulse generator.