ANSI AAMI ISO 14117-2019 PDF

Full title and description

ANSI/AAMI/ISO 14117:2019 — Active implantable medical devices — Electromagnetic compatibility — EMC test protocols for implantable cardiac pacemakers, implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy (CRT) devices. This adoption of ISO 14117:2019 provides test methods, performance limits and documentation requirements for evaluating immunity of implantable pulse generators used with transvenous (endocardial or epicardial) lead systems against electromagnetic (EM) emitters across specified frequency ranges.

Abstract

Specifies comprehensive EMC test protocols for active implantable cardiovascular devices that deliver therapies for bradycardia, tachycardia and cardiac resynchronization. The standard defines test setups, immunity criteria and required manufacturer documentation and is intended primarily for pulse generators used with endocardial or epicardial leads (leadless technologies may require adaptations). It covers interactions with EM emitters in the ranges from DC/low frequency up to 3 000 MHz and provides performance limits or reporting requirements where appropriate.

General information

• Status: Published (ISO edition confirmed/active; adopted as ANSI/AAMI/ISO 14117:2019 for the U.S. catalogue).
• Publication date: September 2019 (Edition 2, published 2019-09).
• Publisher: International Organization for Standardization (ISO); adopted/distributed in U.S. by AAMI and listed in ANSI webstore as ANSI/AAMI/ISO 14117:2019.
• ICS / categories: 11.040.40 (Implants for surgery — active implants); 33.100.01 (Electromagnetic compatibility).
• Edition / version: Edition 2 (ISO 14117:2019).
• Number of pages: 134 pages (ISO published count).

Scope

Defines EMC test methodologies and performance limits for active implantable cardiovascular devices (pacemakers, ICDs, CRT pulse generators) used with transvenous lead systems. The standard addresses device behaviour in the presence of external EM fields across the specified frequency bands (including DC/low frequencies up to 3 000 MHz), specifies immunity test setups and acceptance criteria, and requires manufacturer documentation to describe device immunity characteristics for use by healthcare providers and EM-emitter manufacturers. It is aimed at pulse generators with endocardial or epicardial leads; newer leadless technologies may need adapted procedures.

Key topics and requirements

• EMC test protocols for implanted pulse generators (pacemakers, ICDs, CRT devices) including defined test setups and signal coupling methods.
• Specified frequency ranges and exposure conditions used for immunity testing (notably ranges spanning from 0 Hz up to 3 000 MHz, with partitioning used in test methods).
• Performance limits or requirements to report device behaviour when subjected to EM disturbances; pass/fail criteria and documentation requirements.
• Guidance on protection measures and on information that manufacturers must supply (labeling and instructions) concerning EMC and expected immunity.
• Applicability notes for pulse generators using transvenous lead systems; recognition that non‑lead or leadless technologies may require adaptations.

Typical use and users

Primary users include implantable cardiac device manufacturers, EMC test laboratories, regulatory and conformity assessment bodies, clinical engineers and quality/compliance teams. Design and verification engineers use the standard to define and perform EMC type‑tests; regulatory affairs teams and notified/recognised testing labs use it to demonstrate device behaviour under EM exposure; clinical engineering and hospital procurement may use manufacturer EMC documentation produced to this standard when assessing device suitability for specific clinical environments.

Related standards

Commonly referenced and complementary standards include: ISO 14708 series (active implantable medical devices — device‑specific safety and performance requirements, incl. ISO 14708-2 for pacemakers and ISO 14708-6 for tachyarrhythmia devices); IEC/ISO 60601-1-2 (electromagnetic compatibility — medical electrical equipment); IEC technical specifications and guidance on EMC (for example IEC TS 60601-4-2); ISO 14971 (risk management for medical devices); ISO 10993 series (biological evaluation); and connector/labeling standards such as ISO 27186 / ISO 27185 and related AAMI guidance documents. These standards are typically used in combination when developing, testing and certifying implantable cardiac devices.

Keywords

electromagnetic compatibility, EMC, implantable cardiac device, pacemaker, ICD, CRT, pulse generator, immunity testing, transvenous leads, EMC test protocols, AAMI, ANSI, ISO 14117.

FAQ

Q: What is this standard?

A: ANSI/AAMI/ISO 14117:2019 is the U.S. adoption of ISO 14117:2019 that specifies EMC test protocols for active implantable cardiac devices (pacemakers, ICDs, CRT pulse generators) to evaluate immunity to electromagnetic disturbances.

Q: What does it cover?

A: It covers EMC test methods, exposure conditions, performance limits or reporting requirements, and documentation that manufacturers must supply concerning device immunity. It focuses on pulse generators used with endocardial or epicardial transvenous leads and covers interaction with EM emitters up to 3 000 MHz.

Q: Who typically uses it?

A: Device manufacturers, EMC test labs, regulatory and conformity assessment bodies, clinical engineers, and compliance/risk teams—any stakeholders involved in design verification, regulatory submission or clinical deployment of implantable cardiac rhythm management devices.

Q: Is it current or superseded?

A: ISO 14117:2019 (Edition 2) superseded ISO 14117:2012. The ISO record shows the 2019 edition as published in September 2019 and reviewed/confirmed in 2025; it is the active edition as listed in ISO and in ANSI/AAMI catalogues. Users should confirm any national adoption or later amendments before compliance testing.

Q: Is it part of a series?

A: Yes — ISO 14117 sits alongside other ISO and IEC standards for active implantable medical devices and EMC (for example the ISO 14708 series for implantable cardiac devices, IEC/ISO 60601-1-2 for medical equipment EMC, and various ISO/AAMI documents). Conformity assessment typically references multiple standards together.

Q: What are the key keywords?

A: EMC, implantable cardiac device, pacemaker, ICD, CRT, immunity testing, transvenous lead, pulse generator, ISO 14117, ANSI/AAMI.