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.
Document identifier
AAMI TIR69:2017
Title
Risk Management of Radio-Frequency Wireless Coexistence for Medical Devices and Systems
AAMI Category
Diagnostic and Monitoring
Publication date
2017-04-28
International Relationship
| Price |
243 vnd |
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