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


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.

More AAMI Standards PDF

AAMI TIR17:1997

AAMI TIR17:1997

$55.00 $110.00

AAMI 11737-2

AAMI 11737-2

$44.00 $88.00

AAMI ST42-98

AAMI ST42-98

$55.00 $110.00

AAMI TIR15:1997

AAMI TIR15:1997

$49.00 $99.00