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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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Summary
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. No annex
Technical characteristics
| Publisher | Association for the Advancement of Medical Instrumentation (AAMI) |
| Publication Date | 01/01/2017 |
| Confirmation Date | 01/01/2025 |
| Page Count | 0 |
| Themes | Electromedical Equipment |
| EAN | --- |
| ISBN | --- |
| Weight (in grams) | --- |
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