Medical Grade Power Supplies (IEC 60601-1)

IEC 60601-1 is the main safety standard for medical electrical equipment (ANSI/AAMI ES60601-1 in the US). If your device is a medical electrical device, its power supply normally needs to meet it, or be evaluated as part of the device.

MOPP (Means of Patient Protection) is the stricter isolation level for parts that can reach the patient; MOOP (Means of Operator Protection) is for operators only. Supplies for patient-connected devices typically need 2 × MOPP. The GSM, RPS, MPM, MPS, RPD, RPT, MPT and MPQ datasheets list 2 × MOPP primary-secondary.

Usually not without extra measures. ITE supplies are evaluated to IEC 62368-1 and do not provide the isolation and leakage limits of IEC 60601-1, so the device would need additional isolation and testing.

IEC 60601-1 sets limits for touch, earth and patient leakage current that depend on the applied part type. Each MEAN WELL datasheet lists its measured maximums, for example touch current below 100 µA on the MPM-90, below 70 µA on the RPS-400 and below 50 µA on the GSM18B.

Look for IEC 60601-1-11 on the datasheet. On this page, the GSM18B datasheet lists ANSI/AAMI HA60601-1-11 and CSA 60601-1-11, and the GSM06E and GSM12E datasheets list EN 60601-1-11.