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AAMI TIR66:2017
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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
standard by Association for the Advancement of Medical Instrumentation, 02/28/2017
Full Description
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.Product Details
Published: 02/28/2017 ISBN(s): 9781570206528 Number of Pages: 33File Size: 1 file , 290 KB
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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
standard by Association for the Advancement of Medical Instrumentation, 02/28/2017