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

Published by	Publication Date	Number of Pages
AAMI	02/28/2017	34

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Category: AAMI

Description

AAMI TIR66 – Guidance for the creation of physiologic data and waveform databases to demonstrate reasonable assurance of the safety and effectiveness of alarm system algorithms

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.