{"id":198183,"date":"2024-10-19T12:36:58","date_gmt":"2024-10-19T12:36:58","guid":{"rendered":"https:\/\/pdfstandards.shop\/product\/uncategorized\/aami-tir24-1999-ra-2019\/"},"modified":"2024-10-25T05:10:09","modified_gmt":"2024-10-25T05:10:09","slug":"aami-tir24-1999-ra-2019","status":"publish","type":"product","link":"https:\/\/pdfstandards.shop\/product\/publishers\/aami\/aami-tir24-1999-ra-2019\/","title":{"rendered":"AAMI TIR24 1999 RA 2019"},"content":{"rendered":"
This report defines the nomenclature, ingredients, and principles needed to develop, annotate, evaluate, and use physiologic waveform databases in developing and testing medical devices.<\/p>\n
PDF Pages<\/th>\n | PDF Title<\/th>\n<\/tr>\n | ||||||
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2<\/td>\n | Blank Page <\/td>\n<\/tr>\n | ||||||
4<\/td>\n | Copyright <\/td>\n<\/tr>\n | ||||||
7<\/td>\n | Contents <\/td>\n<\/tr>\n | ||||||
9<\/td>\n | Committee representation <\/td>\n<\/tr>\n | ||||||
10<\/td>\n | Foreword <\/td>\n<\/tr>\n | ||||||
13<\/td>\n | 1\tScope 2\tNormative reference 3\tDefinitions <\/td>\n<\/tr>\n | ||||||
14<\/td>\n | 4\tDatabase requirements 4.1\tIntended use of database 4.2\tClinical requirements 4.2.1\tPopulation 4.2.2\tStudy design 4.3\tEngineering requirements <\/td>\n<\/tr>\n | ||||||
15<\/td>\n | 4.4\tAnnotation requirements 4.5\tArchive requirements 5\tWaveform acquisition and synthesis 5.1\tOverview 5.2\tSignal issues and requirements 5.2.1\tDistortion <\/td>\n<\/tr>\n | ||||||
16<\/td>\n | 5.2.2\tDistortion classifications 5.2.2.1\tLinear distortion 5.2.2.1.1\tAmplitude distortion 5.2.2.1.2\tPhase distortion <\/td>\n<\/tr>\n | ||||||
17<\/td>\n | 5.2.2.2\tNonlinear distortion 5.2.2.2.1\tNonlinear transfer characteristic 5.2.2.2.2\tCoupling 5.2.2.2.3\tAliasing <\/td>\n<\/tr>\n | ||||||
18<\/td>\n | 5.2.3\tSkew 5.2.4\tDuration 5.2.5\tFrequency translation 5.3\tSystem design issues and requirements <\/td>\n<\/tr>\n | ||||||
19<\/td>\n | 5.3.1\tSampling theory considerations 5.3.1.1\tNyquist\u2019s sampling theory 5.3.1.1.1\tPeriodic sampling <\/td>\n<\/tr>\n | ||||||
20<\/td>\n | 5.3.1.1.2\tPeriodic spectra, aliasing, and acquisition <\/td>\n<\/tr>\n | ||||||
22<\/td>\n | 5.3.1.2\tTime series sample rate changes <\/td>\n<\/tr>\n | ||||||
25<\/td>\n | 5.3.1.2.1\tImproper methods of sample rate change (resampling) <\/td>\n<\/tr>\n | ||||||
29<\/td>\n | 5.3.1.2.2\tDecimation-interpolation methods for sample rate changes <\/td>\n<\/tr>\n | ||||||
32<\/td>\n | 5.3.1.3\tSample rate determination and compatibility among databases 5.3.1.4\tNonideal sampling effects 5.3.1.4.1\t Aperture jitter 5.3.1.4.2\tAperture delay <\/td>\n<\/tr>\n | ||||||
33<\/td>\n | 5.3.2\tArchitectural issues 5.3.2.1\tAsynchronous sampling 5.3.2.2\tSynchronous sampling <\/td>\n<\/tr>\n | ||||||
34<\/td>\n | 5.3.3\tChannel acquisition guidelines 5.3.3.1\tAnalog channel frequency response requirements 5.3.3.2\tAnalog channel oversampling guidelines <\/td>\n<\/tr>\n | ||||||
35<\/td>\n | 5.3.3.3\tDigital data acquisition 5.4\tStorage <\/td>\n<\/tr>\n | ||||||
36<\/td>\n | 5.4.1\tRaw signals\u2014analog databases 5.4.2\tWaveforms\u2014digital databases 5.5\tArchive 5.5.1\tEnvironmental considerations <\/td>\n<\/tr>\n | ||||||
37<\/td>\n | 5.5.2\tFormat 5.5.3\tData integrity 5.5.4\tApplicable standards 5.6\tDatabase annotation 5.6.1\tAnnotation process <\/td>\n<\/tr>\n | ||||||
38<\/td>\n | 5.6.2\tAnnotation rules 5.6.3\tData presentation specifications 5.6.3.1\tTime resolution 5.6.3.2\tSignal synchronization 5.6.3.3\tPolarity 5.6.3.4\tSignal gain of each channel <\/td>\n<\/tr>\n | ||||||
39<\/td>\n | 5.7\tMaintenance and distribution 6\tApplication of waveform databases to testing 6.1\tEvaluation of performance 6.2\tTest objectives <\/td>\n<\/tr>\n | ||||||
40<\/td>\n | 6.3\tAlgorithm versus device testing system 6.4\tSufficiency and validity 6.4.1\tSufficiency <\/td>\n<\/tr>\n | ||||||
41<\/td>\n | 6.4.2\tValidity\u2014correct conclusions from results 6.4.3\tPrecautions, limitations, interpolations, and interpretations (limited scope of results) <\/td>\n<\/tr>\n | ||||||
43<\/td>\n | Annex A: CSE ECG Reference Library (Measurement Database) A.1\tAcquisition methodology A.2\tAnnotation methodology A.3\tStorage and distribution methodology <\/td>\n<\/tr>\n | ||||||
44<\/td>\n | A.4\tSignal reconstruction methodology A.5\tStrengths and weaknesses of the database A.6\tReferences <\/td>\n<\/tr>\n | ||||||
45<\/td>\n | Annex B: CSE ECG Reference Library (Diagnostic Database) B.1\tAcquisition methodology B.2\tAnnotation methodology <\/td>\n<\/tr>\n | ||||||
46<\/td>\n | B.3\tStorage and distribution methodology B.4\tSignal reconstruction methodology B.5\tProgram evaluation methodology B.5.1\tComparison with the \u201cclinical truth\u201d B.5.2\tComparison with the combined referee results B.6\tStrengths and weaknesses of the database <\/td>\n<\/tr>\n | ||||||
47<\/td>\n | B.7\tReferences <\/td>\n<\/tr>\n | ||||||
48<\/td>\n | Annex C: MIT-BIH Arrhythmia Database C.1\tAcquisition methodology C.2\tAnnotation methodology C.3\tStorage and distribution methodology C.4\tStrengths and weaknesses of the database <\/td>\n<\/tr>\n | ||||||
49<\/td>\n | C.5\tReferences <\/td>\n<\/tr>\n | ||||||
50<\/td>\n | Annex D: Noise Stress Database D.1\tAcquisition methodology D.2\tStorage and distribution methodology D.3\tStrengths and weaknesses of the database D.4\tReferences <\/td>\n<\/tr>\n | ||||||
51<\/td>\n | Annex E: European ST-T Database E.1\tAcquisition methodology E.2\tAnnotation methodology E.3\tStorage and distribution methodology <\/td>\n<\/tr>\n | ||||||
52<\/td>\n | E.4\tStrengths and weaknesses of the database E.5\tReferences <\/td>\n<\/tr>\n | ||||||
53<\/td>\n | Annex F: American Heart Association Database for Evaluation of Automated Ventricular Arrhythmia Dectectors F.1\tAcquisition methodology F.2\tAnnotation methodology F.3\tStorage and distribution methodology, strengths, and weaknesses of the database F.4\tReferences <\/td>\n<\/tr>\n | ||||||
54<\/td>\n | Annex G: Massachusetts General Hospital\/Marquette Foundation Waveform Database G.1\tAcquisition methodology G.2\tAnnotation methodology G.3\tStorage and distribution methodology, strengths, and weaknesses of the database G.4\tReference <\/td>\n<\/tr>\n | ||||||
55<\/td>\n | Annex H: Creighton University Ventricular Tachyarrhythmia Database H.1\tAcquisition methodology H.2\tAnnotation methodology H.3\tStorage and distribution methodology H.4\tSignal reconstruction methodology <\/td>\n<\/tr>\n | ||||||
56<\/td>\n | H.5\tStrengths and weaknesses of the database H.6\tReference <\/td>\n<\/tr>\n<\/table>\n","protected":false},"excerpt":{"rendered":" AAMI TIR24:1999\/(R)2019 – Acquisition and use of physiologic waveform databases for testing of medical devices<\/b><\/p>\n |