AAMI TIR66:2017(R2025)
Current
The latest, up-to-date edition.
Guidance for the creation of physiologic data and waveform databases to demonstrate reasonable assurance of the safety and effectiveness of alarm system algorithms
Hardcopy , PDF
English
21-02-2025
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.
| DocumentType |
Standard
|
| ISBN |
9781570206528
|
| Pages |
34
|
| PublisherName |
Association for the Advancement of Medical Instrumentation
|
| Status |
Current
|
| Supersedes |
| ANSI/AAMI/IEC 60601-1-8:2006 & A1:2012 | MEDICAL ELECTRICAL EQUIPMENT - PART 1-8: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - COLLATERAL STANDARD: GENERAL REQUIREMENTS, TESTS AND GUIDANCE FOR ALARM SYSTEMS IN MEDICAL ELECTRICAL EQUIPMENT AND MEDICAL ELECTRICAL SYSTEMS |
| AAMI TIR24 : 1999 | ACQUISITION AND USE OF PHYSIOLOGIC WAVEFORM DATABASES FOR TESTING OF MEDICAL DEVICES |
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