ISO 14708-3 Testing

Most medical device manufacturers must comply with IEC 60601-1-2 Medical EMC. This standard requires implantable medical devices to also comply with ISO 14708-3 testing, specifically Section 27 of the ISO 14708-3 standard.

ISO 14708-3 is applicable to active implantable medical devices intended for electrical stimulation of the central or peripheral nervous system. ISO 14708-3 testing is to be carried out on a sample of a device to assess device behavioral responses, and are not intended to be used for the routine testing of manufactured products.

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

Devices that use electricity to stimulate the nervous system are commonly called “neurostimulators.” They produce controlled electrical pulses that are delivered through electrodes in contact with a specific target area. Whether or not a neurostimulator is totally or partially implantable, a lead or extension is usually required to convey stimulation pulses from a form of pulse generator to the electrodes, although newer forms of devices might not utilize leads or extensions. An external programmer might be used to adjust device parameters.

Not included in the scope of ISO 14708 are non-implantable medical devices, such as external neurostimulators and RF-coupled neurostimulators, even though such devices might have implantable parts, because they are covered under the IEC 60601-1 series of standards.

ISO 14708 testing provides an assessment of a devices’ ability to protect a patient from the following hazards:

• Unintentional biological effects being caused by the active implantable medical device.
• Harm to the patient or user caused by external physical features of the active implantable medical device.
• Harm to the patient caused by electricity.
• Harm to the patient caused by heat.
• Ionizing radiation released or emitted from the active implantable medical device.
• Unintended effects caused by the active implantable medical device.

In addition to protecting the patient, the ISO 17048-3 test 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 miscellaneous medical treatments.
• Mechanical forces.
• Damage caused by electrostatic discharge.
• Damage caused by atmospheric pressure changes.
• Damage caused by temperature changes.
• Electromagnetic non-ionizing radiation.

Keystone Compliance is an experienced ISO 14708 test lab. Please complete our easy online request a quote form to receive a quote on ISO 17048-3 testing.