Recognized standard
TIR66: 2017/(R)2020
FDA recognition 5-138 · AAMI · General I (QS/RM)
Key facts
| Recognition number | 5-138 |
|---|---|
| Designation | TIR66: 2017/(R)2020 |
| Title | Guidance for the creation of physiologic data and waveform databases to demonstrate reasonable assurance of the safety and effectiveness of alarm system algorithms |
| Standards developer | Association for the Advancement of Medical Instrumentation |
| Specialty area | General I (QS/RM) |
| Date of entry | Dec 19, 2022 |
| Scope (excerpt) | This document is intended to define the nomenclature, ingredients, and principles for the development, annotation and use of physiologic waveform databases for developing and testing the performance of INTELLIGENT ALARM SYSTEM algorithms, and to test ALARM SYSTEMS incorporating such algorithms. This… |
At a glance
- None Product codes
- 1–9 FDA guidance documents
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About FDA-recognized consensus standards
The FDA recognizes voluntary consensus standards that manufacturers can cite in premarket submissions to show conformity with specific requirements.
Source: U.S. Food and Drug Administration (FDA), Recognized Consensus Standards database · Source date: