Testing a Low Current (Battery) DC Medical Device

We're looking into testing a medical device that is operated using a battery (DC) and running at a very low current level; <100 uA. Are there any standards that outline safety and risk considerations and tests to confirm this for such devices??

Re: Low current DC device

What kind of battery?

Is it re-chargeable?

Re: Low current DC device

It's a non-rechargeable button battery, silver oxide

IEC 60601-1 (plus collaterals and particulars) applies to all electrical medical devices. They may be mains powered, battery powered or both.

There is no distinction made for a low supply current but some parts (thermal risks, fire) would be less relevant due to the limited total energy available from your cell.

Pads38 said:

IEC 60601-1 (plus collaterals and particulars) applies to all electrical medical devices.

Click to expand...

Just a quick comment to avoid confusion. IEC 60601 applies to all "medical electrical equipment"as defined by the standard. There's several electrical medical devices which are not medical electrical equipment.

Anyway, even if the device from the OP is not a medical electrical equipment, he could use the requirements of IEC 60601 to show compliance with electrical safety requirements (even more so if there's no standard related to his device).