Recognition Standards – Radio-frequency Wireless Coexistence for Medical Devices and Systems

The Food and Drug Administration (FDA) is announcing the publication of the standards-recognition notice (Recognition List #47) that includes: American National Standards Institute (ANSI) American National Standard for Evaluation of Wireless Coexistence C63 and Association for the Advancement of Medical Instrumentation (AAMI) Technical Information Report (TIR) 69: Risk management of radio-frequency wireless coexistence for medical devices and systems. This C63.27 standard provides basic wireless coexistence test methods that coordinate with the AAMI Technical Information Report (TIR) 69: Risk Management of Radio-frequency Wireless Coexistence for Medical Devices and Systems. This is the first standard available that specifically addresses wireless coexistence testing that can be used to assess the ability of wireless equipment to coexist with other wireless equipment in its intended use environment. The FDA regularly updates the list of national and international voluntary consensus standards recognized for use in satisfying portions of device premarket review submissions or other requirements.  If you have any questions about these standards, please contact the CDRH Standards Program at CDRHStandardsStaff@fda.hhs.gov. Thank you. Center for Devices and Radiological Health Food and Drug Administration