AAMI EC12 2000 RA2020
$77.96
ANSI/AAMI EC12:2000/(R)2020 Disposable ECG electrodes
| Published By | Publication Date | Number of Pages |
| AAMI | 2020 |
This standard contains minimum labeling, safety, and performance requirements; test methods; and terminology for disposable electrocardiographic (ECG) electrodes.
PDF Catalog
| PDF Pages | PDF Title |
|---|---|
| 1 | ANSI/AAMI EC12:2000/(R)2020, Disposable ECG electrodes |
| 3 | Title Page |
| 4 | AAMI Standard Copyright |
| 5 | Contents |
| 6 | Committee representation |
| 7 | Foreword |
| 8 | 1 Scope 1.1 Inclusions 1.2 Exclusions 2 Normative references 3 Definitions and abbreviations |
| 9 | 4 Requirements 4.1 Labeling requirements 4.2 Performance requirements 4.2.1 Packaging and shelf life |
| 10 | 4.2.2 Electrical performance 4.2.2.1 AC impedance 4.2.2.2 DC offset voltage 4.2.2.3 Combined offset instability and internal noise 4.2.2.4 Defibrillation overload recovery 4.2.2.5 Bias current tolerance |
| 11 | 4.3 Safety requirements 4.3.1 Biological response 4.3.2 Pre-attached leadwire safety 4.4 Adhesive performance (duration of use) 5 Tests 5.1 Labeling 5.2 Performance 5.2.1 Packaging and shelf life 5.2.2 Tests for electrical performance 5.2.2.1 AC impedance |
| 12 | 5.2.2.2 DC offset voltage 5.2.2.3 Combined offset instability and internal noise 5.2.2.4 Defibrillation overload recovery |
| 13 | 5.3 Safety 5.3.1 Biological response evaluation 5.3.1.1 Cytotoxicity 5.3.1.2 Sensitization 5.3.1.3 Irritation 5.3.1.4 Intracutaneous reactivity 5.3.2 Pre-attached leadwire safety |
| 14 | 5.4 Adhesive performance (duration of use) |
| 15 | Annex A: Rationale for the development and provisions of this standard A.1 Need for standard |
| 16 | A.1.1 Inclusions A.1.2 Exclusions A.2 Normative references A.3 Definitions A.4 Rationale for the specific provisions of this standard A.4.1 Rationale for the labeling requirements |
| 17 | A.4.2 Rationale for the performance requirements A.4.2.1 Packaging and shelf life A.4.2.2 Electrical performance A.4.2.2.1 AC Impedance A.4.2.2.2 DC offset voltage |
| 18 | A.4.2.2.3 Combined offset instability and internal noise A.4.2.2.4 Defibrillation overload recovery |
| 19 | A.4.2.2.5 Bias current tolerance A.4.3 Rationale for safety requirements A.4.3.1 Biological response |
| 20 | A.4.3.2 Pre-attached leadwire safety A.4.4 Electrode adhesiveness |
| 21 | Annex B: Cited references |
