AAMI TIR66 2017 RA2020
$115.49
AAMI TIR66: 2017/(R)2020, Guidance for the creation of physiologic data and waveform databases to demonstrate reasonable assurance of the safety and effectiveness of alarm system algorithms
| Published By | Publication Date | Number of Pages |
| AAMI | 2020 |
Reaffirmation
PDF Catalog
| PDF Pages | PDF Title |
|---|---|
| 1 | AAMI TIR66:2017/(R)2020; Guidance for the creation of physiologic data and waveform databases to demonstrate reasonable assurance of the safety and effectiveness of alarm system algorithms |
| 3 | Title page |
| 4 | AAMI Technical Information Report Copyright information |
| 5 | Contents |
| 6 | Glossary of equivalent standards |
| 7 | Committee representation |
| 9 | Foreword |
| 10 | Introduction |
| 11 | 1 Scope 2 Normative references 3 * Terms and definitions |
| 17 | 4 Database requirements 4.1 General 4.2 Database alignment with the intended application of the algorithm |
| 18 | 4.3 Population 4.4 * Study design 4.5 Engineering requirements 4.6 Annotation requirements |
| 19 | 4.7 * Archive requirements 5 Waveform acquisition and synthesis 5.1 Data integrity 5.2 Handling missing values |
| 20 | 5.3 * Defining excluded values 5.4 Database annotation process |
| 21 | 5.5 * Annotators and adjudicators 5.6 Annotation rules for human annotation |
| 23 | 6 Application of waveform databases to testing |
| 24 | 7 Use of a database for algorithm development 8 Alarm system algorithm optimization and tuning |
| 26 | Figure 1 — Example of an ROC analysis plot |
| 27 | Annex A (informative) Rationale and additional guidance |
| 29 | Annex B (informative) Known data sets (either publically available free of charge, or available at a cost) |
| 30 | Bibliography |
| 33 | Terminology—Alphabetized index of defined terms |
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