AAMI TIR69 PDF

AAMI TIR69 – Risk management of radio-frequency wireless coexistence for medical devices and systems

This Technical Information Report (TIR) provides a process and guidance on performing a radio-frequency (RF) wireless coexistence evaluation of a medical device as part of an overall medical device risk management approach. The process includes pre-testing activities to gather information needed to determine the tier at which to perform testing, the testing and report, and post-test analysis. The TIR also provides sample reports and additional information to aid in documenting the medical device wireless coexistence evaluation and integration into risk assessment and management.