AAMI TIR24:1999/(R)2025

This report defines the nomenclature, ingredients, and principles needed to develop, annotate, evaluate, and use physiologic waveform databases in developing and testing medical devices. The objective of this report is to provide an integrated overview of the methodology, technology, and potential pitfalls of acquiring, annotating, reconstructing, and using databases for the testing of medical devices and algorithms. It reflects the conscientious efforts of a group of concerned health care professionals, biomedical engineers, device manufacturers, and government representatives to develop a reference document for those involved in developing medical instrumentation. No annex