FAQ: Wireless Coexistence Testing for Medical Devices

What wireless technology that is used in the medical device can E&E test? 

Eurofins E &E developed a methodology to evaluate medical devices, depending on their wireless functions (Wi-Fi, Bluetooth, ZigBee), operating up to 7.2GHz ISM bands for the following wireless technology systems:

• IEEE 802.11a/b/g/n/j/p
• Long-Term Evolution (LTE, a 4G mobile communications standard)

What standard(s) address wireless coexistence for medical devices?

The applicability of a standard or set of standards depends on the medical device’s intended purpose. The Food and Drug Administration (FDA) issued guidelines to address wireless coexistence for medical devices and recognized the following ones:

• ANSI C63.27/D1.0: American National Standards Institute – Standard for Evaluation of Wireless Coexistence (2017)

The standard specifies methods for assessing the radio frequency (RF) wireless coexistence of equipment that incorporates RF communications. This standard specifies key performance indicators (KPIs) that can be used to assess the ability of the equipment under test (EUT) to coexist with other equipment in its intended operational environment.

• AAMI TIR69:2017/(R)2020: Technical Information Report Risk management of radio-frequency wireless coexistence for medical devices and systems.

This TIR applies to medical devices and systems (also known as medical electrical equipment) that incorporate RF wireless technology used to perform or control a medical function or to communicate medical data. This includes wireless technology whose operation and function directly support the medical device’s intended use, as it relates to the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease.

• ISO 14117 (2012): Active implantable medical devices – Electromagnetic compatibility-EMC test protocols for implantable cardiac pacemakers, implantable cardioverter defibrillators and cardiac resynchronization devices

ISO 14117:2012 specifies test methodologies for the evaluation of the electromagnetic compatibility (EMC) of active implantable cardiovascular devices that provide one or more therapies for bradycardia, tachycardia, and cardiac resynchronization.