I want to design a a battery powered device which measures bioimpedance. It is intended to be powered only by an external battery pack (5V) via a USB cable. I want to make sure that the device is safe and fulfills the IEC 60601 safety requirements. Although the intended power supply is only 5V, I see that the use of USB cable increases the risk of misuse. e.g., the user can connect it to different USB power source. Also, the external battery pack and its charger are not medically approved.
1. Is there any special requirements for USB power supply in 60601? Or, do I have to treat it as the mains supply (240V)?
2. Will using a medically approved isolated dc-dc converter inside my device be enough for the isolation requirements?
1. Is there any special requirements for USB power supply in 60601? Or, do I have to treat it as the mains supply (240V)?
2. Will using a medically approved isolated dc-dc converter inside my device be enough for the isolation requirements?