1. Life support devices or systems are devices or systems which, (a) are intended for surgical implant into the body, or (b) support or sustain life, and (c) whose failure to perform when properly used in accordance with instructions for use provided in the labeling, can be reasonably expected to result in a significant injury of the user.
| 1/ RFI conducted | | B\1 55022, class B; FCC Part 15, level B |
| BVIC compliance | - Electrostatic discharge ESD | IEC / 61000-4-2 level 2 4 kV / 4 kV |
| - RF field susceptibility | IEC / EN 61000-4-3 level 2 3 V/ m |
| - Electrical fa st tra nsie nts/ b ursts on mainsline | IEC / B\1 61000-4-4 level 2 1 kV |
| - Surge | IEC / Bxl 61000-4-5 level 2 0.5 kV / 1 kV |
| Safety standards | | IEC/J 60950, UL/ cUL1950 (File E141988) |
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