Must meet electrical safety standards IEC 60601
| Requirement | Specification | |
| 6 | Device must meet electrical safety standards IEC 60601. | Type of material should be insulated (e.g. plastic)Leakage current cannot exceed 100 uA. |
| Justification | The device is powered and will be in contact with the userMinimize potential risk from electric shocks. | If material is not insulated, potential risk of shock increases. Leakage current limit is derived from sources & IEC 60601. |
Verification: Measuring device leakage current to ensure it is under 100uA
Reference:
[1] International Electrotechnical Commission. “Medical electrical equipment – Part 1-1: General requirements for basic safety and essential performance.” Standard No. IEC 60601-1-1: 2020. IEC, 2020. [2] Livenson, A. R. (1992). Leakage currents in medical electrical devices. Biomedical Engineering, 26(3), 113-120