ILT-U-1590
Medical electrical equipment
V1:
DETERMINATIONS | STANDARD |
| Safety requirements Except the chapters if applicable: – biocompatibility, software validation, electromagnetic compatibility, usability and measurement accuracy | IEC 60601 |
V2:
DETERMINATION | METHOD |
| Leakage Current test | IEC 60601-1 |
V3:
DETERMINATION | METHOD |
| Temperature measurement (resistance method) | IEC 60601-1 11.1.3 cl. |
| Clearances and creepages measurement | IEC 60601-1 |
| Leakage current measurement | IEC 62368-1 IEC 61010-1 |
V4:
DETERMINATION | METHOD |
| Power input measurement | 60601-1: 2006+A1:2013+A12:2015+A2:2021 |
| Hydraulic pressure test | EN 60601-1: 2006+A1:2013+A12:2015+A2:2021 |
V5:
DETERMINATION | METHOD |
| Ball pressure test | EN 60601-1:2006 + A1:2013 + A2:2021 (cl. 8.8.4.1) |
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ILT-U-2103
Electrical determinations. 1B
