AAMI TIR24 : 1999
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
ACQUISITION AND USE OF PHYSIOLOGIC WAVEFORM DATABASES FOR TESTING OF MEDICAL DEVICES
Hardcopy , PDF
09-23-2019
English
01-01-1999
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
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