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.
AAMI TIR66:2017/(R)2020
Original price was: $227.00.$113.00Current price is: $113.00.
Guidance for the creation of physiologic data and waveform databases to demonstrate reasonable assurance of the safety and effectiveness of alarm system algorithms
Association for the Advancement of Medical Instrumentation , 02/28/2017
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