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AAMI TIR24:1999/(R)2019 - Acquisition and use of physiologic waveform databases for testing of medical devices, 1999
- TIR24, Acquisition and use of physiologic waveform databases for testing of medical devices
- Copyright
- Contents
- Committee representation
- Foreword
- 1 Scope
- 2 Normative reference
- 3 Definitions
- 4 Database requirements [Go to Page]
- 4.1 Intended use of database
- 4.2 Clinical requirements [Go to Page]
- 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 [Go to Page]
- 5.1 Overview
- 5.2 Signal issues and requirements [Go to Page]
- 5.2.1 Distortion
- 5.2.2 Distortion classifications [Go to Page]
- 5.2.2.1 Linear distortion [Go to Page]
- 5.2.2.1.1 Amplitude distortion
- 5.2.2.1.2 Phase distortion
- 5.2.2.2 Nonlinear distortion [Go to Page]
- 5.2.2.2.1 Nonlinear transfer characteristic
- 5.2.2.2.2 Coupling
- 5.2.2.2.3 Aliasing
- 5.2.3 Skew
- 5.2.4 Duration
- 5.2.5 Frequency translation
- 5.3 System design issues and requirements [Go to Page]
- 5.3.1 Sampling theory considerations [Go to Page]
- 5.3.1.1 Nyquist’s sampling theory [Go to Page]
- 5.3.1.1.1 Periodic sampling
- 5.3.1.1.2 Periodic spectra, aliasing, and acquisition
- 5.3.1.2 Time series sample rate changes [Go to Page]
- 5.3.1.2.1 Improper methods of sample rate change (resampling)
- 5.3.1.2.2 Decimation-interpolation methods for sample rate changes
- 5.3.1.3 Sample rate determination and compatibility among databases
- 5.3.1.4 Nonideal sampling effects [Go to Page]
- 5.3.1.4.1 Aperture jitter
- 5.3.1.4.2 Aperture delay
- 5.3.2 Architectural issues [Go to Page]
- 5.3.2.1 Asynchronous sampling
- 5.3.2.2 Synchronous sampling
- 5.3.3 Channel acquisition guidelines [Go to Page]
- 5.3.3.1 Analog channel frequency response requirements
- 5.3.3.2 Analog channel oversampling guidelines
- 5.3.3.3 Digital data acquisition
- 5.4 Storage [Go to Page]
- 5.4.1 Raw signals—analog databases
- 5.4.2 Waveforms—digital databases
- 5.5 Archive [Go to Page]
- 5.5.1 Environmental considerations
- 5.5.2 Format
- 5.5.3 Data integrity
- 5.5.4 Applicable standards
- 5.6 Database annotation [Go to Page]
- 5.6.1 Annotation process
- 5.6.2 Annotation rules
- 5.6.3 Data presentation specifications [Go to Page]
- 5.6.3.1 Time resolution
- 5.6.3.2 Signal synchronization
- 5.6.3.3 Polarity
- 5.6.3.4 Signal gain of each channel
- 5.7 Maintenance and distribution
- 6 Application of waveform databases to testing [Go to Page]
- 6.1 Evaluation of performance
- 6.2 Test objectives
- 6.3 Algorithm versus device testing system
- 6.4 Sufficiency and validity [Go to Page]
- 6.4.1 Sufficiency
- 6.4.2 Validity—correct conclusions from results
- 6.4.3 Precautions, limitations, interpolations, and interpretations (limited scope of results)
- Annex A: CSE ECG Reference Library (Measurement Database) [Go to Page]
- A.1 Acquisition methodology
- A.2 Annotation methodology
- A.3 Storage and distribution methodology
- A.4 Signal reconstruction methodology
- A.5 Strengths and weaknesses of the database
- A.6 References
- Annex B: CSE ECG Reference Library (Diagnostic Database) [Go to Page]
- B.1 Acquisition methodology
- B.2 Annotation methodology
- B.3 Storage and distribution methodology
- B.4 Signal reconstruction methodology
- B.5 Program evaluation methodology [Go to Page]
- B.5.1 Comparison with the “clinical truth”
- B.5.2 Comparison with the combined referee results
- B.6 Strengths and weaknesses of the database
- B.7 References
- Annex C: MIT-BIH Arrhythmia Database [Go to Page]
- C.1 Acquisition methodology
- C.2 Annotation methodology
- C.3 Storage and distribution methodology
- C.4 Strengths and weaknesses of the database
- C.5 References
- Annex D: Noise Stress Database [Go to Page]
- D.1 Acquisition methodology
- D.2 Storage and distribution methodology
- D.3 Strengths and weaknesses of the database
- D.4 References
- Annex E: European ST-T Database [Go to Page]
- E.1 Acquisition methodology
- E.2 Annotation methodology
- E.3 Storage and distribution methodology
- E.4 Strengths and weaknesses of the database
- E.5 References
- Annex F: American Heart Association Database for Evaluation of Automated Ventricular Arrhythmia Dectectors [Go to Page]
- F.1 Acquisition methodology
- F.2 Annotation methodology
- F.3 Storage and distribution methodology, strengths, and weaknesses of the database
- F.4 References
- Annex G: Massachusetts General Hospital/Marquette Foundation Waveform Database [Go to Page]
- G.1 Acquisition methodology
- G.2 Annotation methodology
- G.3 Storage and distribution methodology, strengths, and weaknesses of the database
- G.4 Reference
- Annex H: Creighton University Ventricular Tachyarrhythmia Database [Go to Page]
- H.1 Acquisition methodology
- H.2 Annotation methodology
- H.3 Storage and distribution methodology
- H.4 Signal reconstruction methodology
- H.5 Strengths and weaknesses of the database
- H.6 Reference
- Blank Page [Go to Page]