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AAMI TIR66:2017 (R2020)

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 system algorithms 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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Association for the Advancement of Medical Instrumentation [aami]

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