scope:

This document is intended to define the nomenclature, ingredients, and principles to develop, annotate, evaluate, and use physiologic waveform databases for developing and testing medical devices. The TIR identifies issues that should be addressed in the design and development of a physiologic database. It discusses many major pitfalls that must be avoided. Annexes are included that describe several databases in detail. The database profiles that are presented here are intended to serve as a guide in the design, development, acquisition, and documentation of future waveform databases that may be used in the development and evaluation of medical devices and algorithms.

This report considers continuous electrophysiologic signals such as the electrocardiogram and electroencephalogram, as well as nonelectrophysiologic signals such as invasive blood pressure and respiratory tachograms. Medical devices that deal with intermittent data such as thermodilution cardiac output or oscillometric noninvasive blood pressure are not covered in this initial report, but may be included in a later report.