ISO 14117:2019

Overview

ISO 14117:2019 - Active implantable medical devices - Electromagnetic compatibility - EMC test protocols for implantable cardiac pacemakers, implantable cardioverter defibrillators and cardiac resynchronization devices - specifies standardized test methods and documentation for the electromagnetic compatibility (EMC) of implantable cardiovascular pulse generators used with endocardial or epicardial transvenous leads. The standard defines performance limits and immunity requirements across the electromagnetic spectrum from 0 Hz up to 3 000 MHz, with a breakpoint at 385 MHz to distinguish injected (conducted) test methods from radiated-field testing. It also addresses protection in therapeutic environments (surgical high‑frequency exposure, external defibrillators) and required accompanying documentation for manufacturers and transmitter suppliers.

Key technical topics and requirements

• Frequency coverage and test bands: EMC requirements and test procedures for 0 Hz ≤ f ≤ 3 000 MHz, with radiated testing emphasized above the 385 MHz breakpoint.
• Induced lead current: Methods to measure and limit lead currents induced by external electromagnetic fields to prevent inappropriate sensing or therapy.
• Protection against malfunctions:
  • Persistent and transient malfunctions from ambient EM fields, continuous‑wave (CW) sources, and transient low‑frequency fields.
  • Specific requirements for sensing EMI as cardiac signals across subranges (16.6 Hz–150 kHz; 150 kHz–10 MHz; 10 MHz–385 MHz).
• Magnetic field immunity: Requirements for static magnetic flux densities up to 1 mT and up to 50 mT, and AC magnetic fields in the 1 kHz to 140 kHz range.
• Therapeutic environment protections: Tests for damage or malfunction due to surgical high‑frequency exposure and external defibrillator discharges.
• Documentation and labeling: Required disclosure of programmable sensitivity settings, reversion modes, known hazardous behaviors, and minimum separation distances for hand‑held transmitters.
• Normative and informative test fixtures: Annexes provide interface circuits, injection network calibration, torso simulator, dipole antennas, programming settings, simulated cardiac signals, loop area calculations and a sample transient‑exposure evaluation method (Annex O).

Practical applications and users

• Medical device manufacturers use ISO 14117:2019 for design verification, EMC compliance testing, risk assessment, and to produce required user/training documentation.
• Independent EMC test laboratories implement the specified test setups (injection networks, radiated field tests, torso simulators) to validate device immunity and deliver test reports for regulatory submissions.
• Regulators and notified bodies review test evidence based on the standard for market approval.
• Hospitals, clinical engineers and transmitter manufacturers use the standard’s guidance to understand device immunity levels, safe separation distances, and potential hazards in clinical environments.

Related standards

ISO 14117:2019 is used alongside general EMC standards, implantable device safety and ISO/IEC directives. Manufacturers should coordinate EMC testing with applicable regulatory guidance and other medical device standards when preparing submissions.