AAMI TIR24 : 1999

Committee representation
Acknowledgments
Foreword
Introduction
1 Scope
2 Normative reference
3 Definitions
4 Database requirements
  4.1 Intended use of database
  4.2 Clinical requirements
      4.2.1 Population
      4.2.2 Study design
  4.3 Engineering requirements
  4.4 Annotation requirements
  4.5 Archive requirements
5 Waveform acquisition and synthesis
  5.1 Overview
  5.2 Signal issues and requirements
      5.2.1 Distortion
      5.2.2 Distortion classifications
      5.2.3 Skew
      5.2.4 Duration
      5.2.5 Frequency translation
  5.3 System design issues and requirements
      5.3.1 Sampling theory considerations
      5.3.2 Architectural issues
      5.3.3 Channel acquisition guidelines
  5.4 Storage
      5.4.1 Raw signals-analog databases
      5.4.2 Waveforms-digital databases
  5.5 Archive
      5.5.1 Environmental considerations
      5.5.2 Format
      5.5.3 Data integrity
      5.5.4 Applicable standards
  5.6 Database annotation
      5.6.1 Annotation process
      5.6.2 Annotation rules
      5.6.3 Data presentation specifications
  5.7 Maintenance and distribution
6 Application of waveform databases to testing
  6.1 Evaluation of performance
  6.2 Test objectives
  6.3 Algorithm versus device testing system
  6.4 Sufficiency and validity
      6.4.1 Sufficiency
      6.4.2 Validity-correct conclusions from results
      6.4.3 Precautions, limitations, interpolations, and
            interpretations (limited scope of results)
Annexes
A - CSE ECG Reference Library (Measurement Database)
B - CSE ECG Reference Library (Diagnostic Database)
C - MIT-BIH Arrhythmia Database
D - Noise Stress Database
E - European ST-T Database
F - American Heart Association Database for Evaluation of
    Automated Ventricular Arrhythmia Detectors
G - Massachusetts General Hospital/Marquette Foundation
    Waveform Database
H - Creighton University Ventricular Tachyarrhythmia Database

Covers the nomenclature, ingredients, and principles to develop, annotate, evaluate, and use physiologic waveform databases for developing and testing medical devices.