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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

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

Publisher: AAMI

File Format: PDF

$113.00$227.00


Standard By:Association for the Advancement of Medical Instrumentation , 02/28/2017
Published:02/28/2017
Pages:34
ISBN(s):9781570206528
File Size:1 file , 480 KB
Language:English
Note:This product is unavailable in Belarus, Russia, Ukraine
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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