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AAMI TIR66:2017/(R)2020

M00010982

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AAMI TIR66:2017/(R)2020 Guidance for the creation of physiologic data and waveform databases to demonstrate reasonable assurance of the safety and effectiveness of alarm system algorithms

standard by Association for the Advancement of Medical Instrumentation, 02/28/2017

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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.

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