ISO 14117 Active Implantable Medical Devices - Electromagnetic Compatibility - Implantable Pacemakers - EMC Test Protocols for Implantable Cardioverter Defibrillators and Cardiac Resynchronization Devices

This standard specifies test methodologies for the evaluation of electromagnetic compatibility (EMC) of active implantable cardiovascular devices providing one or more treatments for bradycardia, tachycardia, and cardiac resynchronization in conjunction with transvenous lead systems.

This standard is designed for pulse generators used with endocardial or epicardial leads. At the time of this edition, the authors recognized that technologies that do not use endocardial leads or epicardial leads were emerging and would require adaptation of this part. Such adaptations are left to the discretion of manufacturers using these technologies.

This standard also specifies the requirements for the protection of these devices from EM fields encountered in a therapeutic setting and defines the necessary accompanying documentation, providing EM emitter manufacturers with information on expected immunity levels.

EUROLAB assists manufacturers with ISO 14117 test compliance. Our test experts, with their professional working mission and principles, provide you, our manufacturers and suppliers, the best service and controlled testing process in our laboratories. Thanks to these services, businesses receive more effective, high-performance and quality testing services and provide safe, fast and uninterrupted service to their customers.