Technical Standard

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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.

Product Details

Published:

04/28/2017

ISBN(s):

9781570206566

Number of Pages:

61

File Size:

1 file , 460 KB