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.
Document identifier
AAMI TIR66:2017
Title
Guidance for the creation of physiologic data and waveform databases to demonstrate reasonable assurance of the safety and effectiveness of alarm system algorithms
AAMI Category
Diagnostic and Monitoring
Publication date
2017-02-28
International Relationship
| Price |
200 vnd |
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