ISO 14117-2019 PDF

Full title and description

Active implantable medical devices — Electromagnetic compatibility — EMC test protocols for implantable cardiac pacemakers, implantable cardioverter defibrillators and cardiac resynchronization devices. This International Standard (ISO 14117:2019, 2nd edition) specifies test methods, performance limits and documentation requirements used to evaluate electromagnetic compatibility (EMC) of implantable cardiovascular pulse generators used with transvenous or epicardial lead systems.

Abstract

ISO 14117:2019 defines EMC test methodologies and performance limits for active implantable cardiovascular devices that provide therapies for bradycardia, tachycardia and cardiac resynchronization. The document addresses interactions with electromagnetic emitters across defined frequency bands, sets immunity/performance criteria, describes protection requirements in clinical/therapeutic environments and specifies required manufacturer documentation to inform users and other equipment manufacturers of expected device immunity and limitations.

General information

• Status: Published (confirmed at review).
• Publication date: September 2019 (2nd edition).
• Publisher: International Organization for Standardization (ISO).
• ICS / categories: 11.040.40; 33.100.01.
• Edition / version: Edition 2 (2019).
• Number of pages: 134.

Scope

Specifies EMC test protocols for active implantable cardiovascular pulse generators (pacemakers, implantable cardioverter‑defibrillators and cardiac resynchronization devices) used with endocardial or epicardial leads. It sets the electromagnetic frequency ranges and associated test approaches (injected‑voltage and radiated testing), performance limits or required disclosures, and documentation obligations. The standard is intended for type testing to demonstrate device immunity in the presence of typical and foreseeable electromagnetic emitters encountered in therapeutic environments.

Key topics and requirements

• Defined EMC frequency ranges and test breakpoints: the document distinguishes test regimes across the low and radiofrequency bands (notably covering approximately 0 Hz up to 3 000 MHz with a breakpoint for injected vs radiated tests around 385 MHz).
• Test methodologies for injected‑voltage and radiated immunity specific to implantable pulse generators and their lead systems, including lead‑injection configurations and test fixtures.
• Performance limits and criteria for temporary, transient and permanent malfunction; requirements for reporting and labeling where immunity limits are exceeded.
• New / clarified topics introduced in the 2019 edition: definitions for “interference mode” and “transient exposure,” revised frequency breakpoint (450 MHz → 385 MHz), new coverage of transient low‑frequency exposures, minimum separation distances from hand‑held transmitters, and annexes addressing multi‑electrode lead connections and methods for evaluating transient/permanent malfunction.
• Requirements for manufacturer documentation (accompanying information for users and for manufacturers of EM emitters) describing expected immunity and safe‑use guidance in electromagnetic environments.

Typical use and users

Used by medical device manufacturers (design and compliance engineers) developing implantable cardiac devices and lead systems, EMC test laboratories performing type and pre‑market EMC testing, regulatory and notified bodies reviewing device conformity, clinical engineers assessing device environment risks, and product safety / standards teams preparing device documentation and labeling.

Related standards

ISO 14117 is part of the active implantable medical device ecosystem and is commonly used alongside other device‑specific and EMC standards, for example ISO 14708 (active implantable medical devices — cardiac pacemaker and related parts), IEC 60601‑1‑2 (medical electrical equipment — EMC collateral standard for ME equipment and systems), and ISO 14971 (risk management for medical devices). These related standards address device‑specific safety/performance, general EMC requirements for medical electrical equipment, and risk management practices used to evaluate EMC‑related hazards.

Keywords

Active implantable medical devices; implantable pacemaker; ICD; cardiac resynchronization; electromagnetic compatibility; EMC testing; immunity testing; radiated immunity; injected voltage testing; leads; medical device standards; ISO 14117:2019.

FAQ

Q: What is this standard?

A: ISO 14117:2019 is an international standard that defines EMC test protocols and performance expectations for active implantable cardiovascular devices (pacemakers, ICDs and CRT devices) used with transvenous or epicardial leads.

Q: What does it cover?

A: It covers specific test methods (injected and radiated tests), frequency ranges of concern, performance limits, handling of transient and permanent malfunctions, required manufacturer information and protective measures to reduce EMC‑related risks in clinical environments.

Q: Who typically uses it?

A: Device manufacturers, EMC test laboratories, regulatory reviewers, clinical/biomedical engineers and standards compliance teams use ISO 14117 when designing, testing and documenting implantable cardiac devices and their electromagnetic safety claims.

Q: Is it current or superseded?

A: ISO 14117:2019 is the current (2nd) edition published in September 2019; it supersedes ISO 14117:2012 and the 2019 edition has been reviewed/confirmed in subsequent ISO reviews.

Q: Is it part of a series?

A: Yes — ISO 14117 is one standard within the broader body of active implantable medical device standards (for example the ISO 14708 series for implantable devices) and is commonly referenced together with general EMC and safety standards (IEC 60601‑1‑2) and risk management standards (ISO 14971).

Q: What are the key keywords?

A: Implantable device EMC, pacemaker EMC testing, ICD EMC, CRT devices, radiated immunity, injected voltage testing, transient exposure, lead systems, manufacturer documentation, EMC performance limits.