IEC60601-1 - Battery Charger Requirement - Home Healthcare Medical Device

A

Andy lee

Hello,

I need your advice and guidance please!

We are designing a medical device battery powered , hand-held, home health care.

The medical device should be charged from stationary battery charger.
the connector pin of stationary battery charger is exposed.

I think medical device should be complied with IEC 60601-1, IEC60601-11
so it should be IP22

Then,

What standard is applied to battery charger?
IEC 60601-1, IEC 60601-1-11?

I would like to know IP class requirement for the stationary battery charger.

I would appreciate very much if anyone could help me!
 
M

Mark Meer

Trusted Information Resource
The battery-charger is (presumably) non-transit-operable. Therefore, by IEC60601-1-11 (presuming the device is charged in the home environment), the ingress protection requirement is IPX1 (i.e. dripping water shall have no harmful effect).

You should (if you don't already) have documented in your risk analysis consideration for ingress into the charger. If this is the case, I would presume you've already got a fuse or some other control to mitigate against potential shorts or electrical hazards due to fluid ingress.

Bottom line:
- Non-transit-operable (and not body-worn or hand-held): IP21
- Risk management & controls supports "no harmful effect" due to ingress
 
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