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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