AAMI TIR24 1999 RA 2019
$131.66
AAMI TIR24:1999/(R)2019 – Acquisition and use of physiologic waveform databases for testing of medical devices
| Published By | Publication Date | Number of Pages |
| AAMI | 1999 | 56 |
This report defines the nomenclature, ingredients, and principles needed to develop, annotate, evaluate, and use physiologic waveform databases in developing and testing medical devices.
PDF Catalog
| PDF Pages | PDF Title |
|---|---|
| 2 | Blank Page |
| 4 | Copyright |
| 7 | Contents |
| 9 | Committee representation |
| 10 | Foreword |
| 13 | 1 Scope 2 Normative reference 3 Definitions |
| 14 | 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 |
| 15 | 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 |
| 16 | 5.2.2 Distortion classifications 5.2.2.1 Linear distortion 5.2.2.1.1 Amplitude distortion 5.2.2.1.2 Phase distortion |
| 17 | 5.2.2.2 Nonlinear distortion 5.2.2.2.1 Nonlinear transfer characteristic 5.2.2.2.2 Coupling 5.2.2.2.3 Aliasing |
| 18 | 5.2.3 Skew 5.2.4 Duration 5.2.5 Frequency translation 5.3 System design issues and requirements |
| 19 | 5.3.1 Sampling theory considerations 5.3.1.1 Nyquist’s sampling theory 5.3.1.1.1 Periodic sampling |
| 20 | 5.3.1.1.2 Periodic spectra, aliasing, and acquisition |
| 22 | 5.3.1.2 Time series sample rate changes |
| 25 | 5.3.1.2.1 Improper methods of sample rate change (resampling) |
| 29 | 5.3.1.2.2 Decimation-interpolation methods for sample rate changes |
| 32 | 5.3.1.3 Sample rate determination and compatibility among databases 5.3.1.4 Nonideal sampling effects 5.3.1.4.1 Aperture jitter 5.3.1.4.2 Aperture delay |
| 33 | 5.3.2 Architectural issues 5.3.2.1 Asynchronous sampling 5.3.2.2 Synchronous sampling |
| 34 | 5.3.3 Channel acquisition guidelines 5.3.3.1 Analog channel frequency response requirements 5.3.3.2 Analog channel oversampling guidelines |
| 35 | 5.3.3.3 Digital data acquisition 5.4 Storage |
| 36 | 5.4.1 Raw signals—analog databases 5.4.2 Waveforms—digital databases 5.5 Archive 5.5.1 Environmental considerations |
| 37 | 5.5.2 Format 5.5.3 Data integrity 5.5.4 Applicable standards 5.6 Database annotation 5.6.1 Annotation process |
| 38 | 5.6.2 Annotation rules 5.6.3 Data presentation specifications 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 |
| 39 | 5.7 Maintenance and distribution 6 Application of waveform databases to testing 6.1 Evaluation of performance 6.2 Test objectives |
| 40 | 6.3 Algorithm versus device testing system 6.4 Sufficiency and validity 6.4.1 Sufficiency |
| 41 | 6.4.2 Validity—correct conclusions from results 6.4.3 Precautions, limitations, interpolations, and interpretations (limited scope of results) |
| 43 | Annex A: CSE ECG Reference Library (Measurement Database) A.1 Acquisition methodology A.2 Annotation methodology A.3 Storage and distribution methodology |
| 44 | A.4 Signal reconstruction methodology A.5 Strengths and weaknesses of the database A.6 References |
| 45 | Annex B: CSE ECG Reference Library (Diagnostic Database) B.1 Acquisition methodology B.2 Annotation methodology |
| 46 | B.3 Storage and distribution methodology B.4 Signal reconstruction methodology B.5 Program evaluation methodology 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 |
| 47 | B.7 References |
| 48 | Annex C: MIT-BIH Arrhythmia Database C.1 Acquisition methodology C.2 Annotation methodology C.3 Storage and distribution methodology C.4 Strengths and weaknesses of the database |
| 49 | C.5 References |
| 50 | Annex D: Noise Stress Database D.1 Acquisition methodology D.2 Storage and distribution methodology D.3 Strengths and weaknesses of the database D.4 References |
| 51 | Annex E: European ST-T Database E.1 Acquisition methodology E.2 Annotation methodology E.3 Storage and distribution methodology |
| 52 | E.4 Strengths and weaknesses of the database E.5 References |
| 53 | Annex F: American Heart Association Database for Evaluation of Automated Ventricular Arrhythmia Dectectors F.1 Acquisition methodology F.2 Annotation methodology F.3 Storage and distribution methodology, strengths, and weaknesses of the database F.4 References |
| 54 | Annex G: Massachusetts General Hospital/Marquette Foundation Waveform Database G.1 Acquisition methodology G.2 Annotation methodology G.3 Storage and distribution methodology, strengths, and weaknesses of the database G.4 Reference |
| 55 | Annex H: Creighton University Ventricular Tachyarrhythmia Database H.1 Acquisition methodology H.2 Annotation methodology H.3 Storage and distribution methodology H.4 Signal reconstruction methodology |
| 56 | H.5 Strengths and weaknesses of the database H.6 Reference |
