ISO 14708-3 Implants for Surgically-Active Implantable Medical Devices-Test Standard for Implantable Neurostimulators

ISO 14708-3 is applicable to active implantable medical devices designed for electrical stimulation of the central or peripheral nervous system. ISO 14708-3 testing will be performed on a device sample to evaluate device behavioral responses and is not intended to be used in routine testing of manufactured products.

The ISO 14708-3 standard specifies specific requirements for active implantable medical devices designed for electrical stimulation of the central or peripheral nervous system to provide basic safety assurance for both patients and users.

Devices that use electricity to stimulate the nervous system are often called "neurostimulators". They produce controlled electrical pulses that are transmitted through electrodes in contact with a specific target area. Whether or not a neurostimulator is fully or partially implantable, a lead or extension is usually required to deliver the stimulation pulses from some type of pulse generator to the electrodes, although newer types of devices may not use leads or extensions. An external programmer can be used to set device parameters.

The ISO 14708-3 test provides an assessment of a device's ability to protect the patient from the following hazards:

• Unintentional biological effects caused by an active implantable medical device.
• Harm to the patient or user of the external physical properties of an active implantable medical device.
• Damage to the patient due to electricity.
• It causes harm to the patient due to heat.
• Ionizing radiation emitted or emitted from an active implantable medical device.
• Undesirable effects caused by active implantable medical device.

In addition to protecting the patient, ISO 17048-3 testing also aims to protect the active implantable device from the following hazards:

• Damage caused by external defibrillators.
• Changes caused by electrical Fields applied directly to the patient.
• Changes caused by various medical treatments.
• Mechanical forces.
• Damage caused by electrostatic discharge.
• Damages caused by atmospheric pressure changes.
• Damages caused by temperature changes.
• Electromagnetic non-ionizing radiation.

EUROLAB assists manufacturers with ISO 14708-3 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.