Wireless Testing

More and more manufacturers incorporate wireless technology such as Wi-Fi, Bluetooth, ZigBee, radio-frequency-identification (RFID) readers and cellular/mobile phone into medical device. Wireless medical device increases patient mobility, allows health care professionals to remotely program devices, enables physicians to remotely access and monitor patient data in real time, thereby significantly improve patient outcomes. However, unique risks related to wireless medical device should be addressed.

STEMart provide necessary wireless testing to help manufacturer comply with regulatory requirements and improve product performance.

Wireless Testing

• FDA wireless coexistence testing

Wireless coexistence is the compatibility of a wireless device with other wireless systems performing tasks may, or may not, be using the same set of rules in a given shared environment.

According to IEEE/ANSI C63.27 and AIM 7351731, STEMart provides wireless coexistence testing to help manufacturer qualify the ability of wireless medical device to reliably, safely and effectively transmit data and information in a shared environment.

• 5G compliance testing

In accordance with various national and regional regulatory requirements, as well as special 5G industry requirements based on conformance, interoperability and field testing defined by Global Certification Forum (GCF) and PCS Type Certification Review Board (PTCRB), STEMart provides state-of-the-art 5G compliance testing to ensure the safety, security, interoperability and market compliance of devices using 5G technology.

• Radio frequency (RF) testing

STEMart provides RF testing for medical devices incorporating Wi-Fi, Zigbee, PMR radio, RFID, NFC, GPS, cellular technologies, etc., to verify whether they can effectively use the radio spectrum without interfering with other users of the radio frequency spectrum.

RF testing capabilities:

• Transmitter tests
• Output Power
• Adjacent Channel Leakage Power Ratio
• Power Spectral Density
• Spectrum Emission Mask
• Occupied Channel Bandwidth
• Frequency Stability / Error
• Radiated Band Edge
• Duty Cycle
• Modulation Bandwidth
• Transmitter unwanted emissions in the out-of-band or spurious Domain
• Receiver tests
• Sensitivity
• Adjacent Channel / Frequency Band Selectivity
• Receiver Spurious Emissions
• Receiver Intermodulation
• Blocking
• Electromagnetic field (EMF) testing

EMF testing measures the amount of electric, magnetic and electromagnetic exposure a product emits to its users to.

STEMart can help manufacturers to ensure the EMF emissions of their wireless product are compliant with regulatory requirements with the following EMF testing:

• Magnetic field measurement
• Electric field measurement
• Electromagnetic field measurement
• Magnetic flux density measurement
• Specific absorption rate (SAR) testing
• Bluetooth qualification testing

In order to display the Bluetooth® trademarks on the product, manufacturers are required to become an adopter member of the Bluetooth Special Interest Group (SIG), and then make their product successfully complete the Bluetooth Qualification Process.

STEMart can help manufacturer complete regulatory compliance and certification process with our:

• Advisory services
• Bluetooth Low Energy RF PHY
• Profile conformance
• Debugging faults
• Interoperability testing
• Bluetooth® qualification testing

SETMart provides a one-stop testing service for wireless medical device. If you want to learn more detail about our wireless testing service, or would like to consult with the experts at STEMart, please feel free to contact us.