AAMI TIR66:2017/(R)2020

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Provides guidance to manufacturers that change existing or create new alarm systemalgorithms as to how to create evidence that demonstrates a reasonable assurance of the safety and efficacy of the algorithm. This document also provides guidance to authorities having jurisdiction for the assessment of such evidence.

Product Details

Published:
02/28/2017
ISBN(s):
9781570206528
Number of Pages:
34
File Size:
1 file , 480 KB

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