Is IEC 60601 compliance possible when only generic power-supply is specified?

M

Mark Meer

Trusted Information Resource
#1
#1
I'm looking at a medical device (on market in EU and USA), that is chargeable via USB.

Included in the system-kit is simply the device and a USB cable. The charging instructions in the accompanying documents says simply to connect it to "any reliable USB connection" in order to charge the internal battery.

My question is: is this acceptable by IEC 60601-1 or 60601-1-2?

The User Instructions say that it is IEC 60601-1 & 60601-1-2 compliant (as does their 510(k) statement).

Is there a clause that I'm missing that allows for such a generic power-source to be specified? If so, how on earth are the other tests (e.g. emissions) reliably tested without a standard power-supply?

Feedback much appreciated!
MM.
 
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M

Marcelo

Inactive Registered Visitor
#4
#4
It's acceptable (but you probably will need more information than only "any reliable USB connection"because you need to define what is a safe and "reliable" connection), but I'm not sure if it will comply.

The generic requirements are in 5.5, 7.2.5 (if an ME system), 7.9.2.3, 7.9.2.14 (if an ME system) and 8.2.1.

This will also affect some of the tests, in particular some electrical tests.
 
P

Peter Selvey

Staff member
Moderator
#5
#5
In principle you can assess the charger under the system requirements in Clause 16. There are a few references to this e.g. 7.9.2.3, 8.2.1. Search the standard for the phrase "separate power supply" to find related requirements. Keep in mind Clause 16 might take a bit of work though.

For safety and EMC, in principle it is OK to assume other regulations take care of the USB supply.

In risk management, you could review the situation from two sides:
a) are the EMC / safety standards enough for the situation
b) the risk of using a non-approved power supply

For this it is case by case, and depends on the medical device, patient interface, duration of contact, patient condition (conscious, capable), possibility for interference with sensitive measurements etc.

Some might argue (b) is not required but recently there were incidents UK and Australia (maybe elsewhere) with $5 USB chargers found in street markets, they were non-approved, with reports of shock, fire and at least one death. If the medical device has say an ECG or electrode connection the patient, it might be prudent to add more insulation and or special warnings as a risk control.
 
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