ISO 14708-2-2019 PDF

Full title and description

St ISO 14708-2-2019 — Implants for surgery — Active implantable medical devices — Part 2: Cardiac pacemakers. This international standard specifies particular requirements and type tests applicable to active implantable devices intended to treat bradyarrhythmias and devices providing cardiac resynchronization therapy (pulse generators and associated leads, plus some non‑implantable parts and accessories).

Abstract

The standard defines type tests and measurement methods to demonstrate compliance for bradyarrhythmia pulse generators used with endocardial or epicardial leads; it recognises emerging leadless technologies (leaving adaptations to manufacturers) and states that electrical characteristics shall be determined by the methods in the standard or by methods demonstrated to be of equal or better accuracy. Features intended to treat tachyarrhythmias are covered in ISO 14708‑6.

General information

• Status: Published — confirmed current (last reviewed/confirmed in 2025).
• Publication date: September 2019 (Edition 3, 2019).
• Publisher: International Organization for Standardization (ISO).
• ICS / categories: 11.040.40 (Implants for surgery, prosthetics and orthotics).
• Edition / version: Edition 3 (2019).
• Number of pages: 71 pages (typical ISO publication length for this part).

Scope

Specifies particular requirements and type tests for active implantable cardiac pacemakers intended to treat bradyarrhythmias and for devices that provide therapies for cardiac resynchronization. Applies primarily to pulse generators used with endocardial or epicardial leads and, where relevant, to non‑implantable parts and accessories that can affect safety or performance. The standard leaves adaptations for emerging leadless technologies to manufacturers.

Key topics and requirements

• Type testing requirements to demonstrate performance and safety of pacemaker systems (pulse generators and leads).
• Electrical characteristic measurements and specified test methods (or equivalent validated methods).
• Requirements covering compatibility with endocardial and epicardial leads and some accessories; guidance on leadless device adaptations.
• Performance requirements for therapies addressing bradyarrhythmias and cardiac resynchronization (CRT).
• References to related parts of the ISO 14708 series where functions for tachyarrhythmia therapy (ICDs) and other device types are covered.

Typical use and users

Used by medical device manufacturers (design and verification teams), test laboratories performing type testing, regulatory and conformity assessment bodies, clinical engineers, and procurement specialists to specify, test and verify cardiac pacemaker products and related accessories against internationally accepted requirements.

Related standards

Key related parts of the ISO 14708 series and other relevant standards include: - ISO 14708‑1 (general requirements for active implantable medical devices: safety, marking and manufacturer information). - ISO 14708‑3 (implantable neurostimulators — related requirements for another device family in the same series). - ISO 14708‑4 (implantable infusion pumps — particular requirements). - ISO 14708‑5 (circulatory support devices). - ISO 14708‑6 (particular requirements for devices intended to treat tachyarrhythmia, e.g., ICDs/CRT‑D).

Keywords

cardiac pacemaker; active implantable medical device; pulse generator; bradyarrhythmia; cardiac resynchronization therapy (CRT); type testing; leads; implantable device requirements; ISO 14708.

FAQ

Q: What is this standard?

A: ISO 14708‑2:2019 is the part of the ISO 14708 series that sets out particular requirements and type tests for cardiac pacemakers (active implantable pulse generators and associated leads) intended to treat bradyarrhythmias and provide CRT.

Q: What does it cover?

A: It covers performance and type test requirements, methods for measuring electrical characteristics, applicability to endocardial and epicardial leads, and applicability to some non‑implantable parts and accessories; it also notes the need for manufacturer adaptation for leadless technologies. Features for tachyarrhythmia therapy are covered in ISO 14708‑6.

Q: Who typically uses it?

A: Device manufacturers (design, verification and regulatory teams), independent test laboratories, regulatory/approval agencies, clinical engineers, and standards/quality professionals use this standard when specifying, testing and assessing pacemaker systems.

Q: Is it current or superseded?

A: ISO 14708‑2:2019 (Edition 3, published September 2019) replaced the 2012 edition; the ISO record shows this edition was last reviewed and confirmed as current in 2025, so it remains the current edition.

Q: Is it part of a series?

A: Yes — ISO 14708 is a multipart series on active implantable medical devices. Part 1 provides general requirements; Parts 2, 3, 4, 5, 6, etc., cover particular device families (pacemakers, neurostimulators, infusion pumps, circulatory support devices, ICDs/tachyarrhythmia devices). Users should consult the relevant part(s) for device‑specific requirements.

Q: What are the key keywords?

A: Cardiac pacemaker; bradyarrhythmia; CRT; active implantable medical device; pulse generator; leads; type testing; electrical characteristics; ISO 14708.