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

Description

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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