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AAMI TIR66:2017/(R)2025

Guidance for the creation of physiologic data and waveform databases to demonstrate reasonable assurance of the safety and effectiveness of alarm system algorithms
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AAMI TIR66:2017/(R)2025

Guidance for the creation of physiologic data and waveform databases to demonstrate reasonable assurance of the safety and effectiveness of alarm system algorithms

PUBLISH DATE 2017
AAMI TIR66:2017/(R)2025
This Technical Information Report (TIR) 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.
SDO AAMI: Assoc. for the Advancement of Medical Instrumentation
Document Number TIR66
Publication Date Jan. 1, 2017
Language en - English
Page Count
Revision Level
Supercedes
Committee
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