ISO 14708-6:2019

Overview

ISO 14708-6:2019 - Implants for surgery - Active implantable medical devices - Part 6 specifies particular requirements for active implantable medical devices intended to treat tachyarrhythmia, including implantable cardioverter defibrillators (ICDs) and combined CRT‑D devices. It supplements the general safety and information requirements in ISO 14708-1 and focuses on type testing, device characteristics, packaging, markings, and protection measures to ensure patient and user safety for tachyarrhythmia therapies.

Key topics and technical requirements

This standard addresses technical and safety topics relevant to ICDs and CRT‑Ds, including:

• Scope and applicability: Requirements apply to implantable pulse generators, leads (endocardial and epicardial), some non‑implantable parts and accessories, and emerging leadless technologies (manufacturers to adapt where necessary).
• Type tests and measurement: Defines type tests and measurement clauses for pulse generator and lead characteristics - e.g., ICD output voltage, delivered capacitor discharge (CD) pulse energy, antitachyarrhythmia pacing (ATP) pulse amplitude, sensitivity (including automatic sensitivity control), charge time and capacitor formation, and electrical lead characteristics.
• Packaging and labelling: General arrangement, sales packaging, sterile pack and non‑reusable pack construction, and mandatory markings on devices and packaging.
• Electrical, thermal and mechanical protection: Protection from unintended biological effects, electrical hazards, heat (including temporary exposure criteria for outer surface temperatures exceeding 39 °C), ionizing and non‑ionizing radiation, electrostatic discharge, atmospheric pressure and temperature changes, and external defibrillator exposure.
• Software, data security and usability: General requirements for non‑implantable parts and software, usability, risk management, and data protection against unauthorized tampering.
• Ancillary topics: Requirements for test accuracy, risk management priorities, and notes on coding modes for implantable pulse generators.

Practical applications and who uses ISO 14708-6:2019

ISO 14708-6:2019 is used by:

• Medical device manufacturers - for design inputs, verification and type testing of ICDs and CRT‑Ds, and packaging/label decisions.
• Regulatory and quality teams - to prepare technical files and conformity evidence for approvals and CE/market submissions.
• Test laboratories and notified bodies - to perform standardized type tests and evaluate compliance.
• Clinical engineers and hospital procurement - to assess device safety, labeling, and compatibility with clinical workflows.
• R&D and product managers - to align product roadmaps with international safety and performance expectations.

Practical outcomes include safer device design, consistent testing methods, clearer labeling and packaging, and implementation of software and cybersecurity best practices for tachyarrhythmia implantable devices.

Related standards

• ISO 14708-1 - General requirements for active implantable medical devices
• ISO 14708-2 - Requirements for bradyarrhythmia and cardiac resynchronization pacing
• ISO 14117 - Electromagnetic immunity tests (referenced for some requirements)
• ISO/TR 14283 - Essential principles of safety and performance

Keywords: ISO 14708-6:2019, implantable cardioverter defibrillators, ICD, CRT-D, tachyarrhythmia, active implantable medical devices, type tests, device safety, medical device standards.