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AAMI TIR66:2017

Guidance for the creation of physiologic data and waveform databases to demonstrate reasonable assurance of the safety and effectiveness of alarm system algorithms

Summary: 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.

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February 28, 2017
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