Separate Medical Device 12V Power Source - What inspection and testing is required?

SteveK

Trusted Information Resource
#1
Planning to run a Class IIa device on a 12V external power adaptor (which drives an internal 12V pump/motor) i.e. which itself plugs into the mains. Accordingly the whole thing then becomes a ME System as per IEC 60601-1 and clause 8.2.1 specifically (Connection to a separate power source). Now this clause then indicates that “Compliance is checked by inspection and by testing as specified in 5.5f.”
Fine so far; then you go to 5.5f – “If the instructions for use specify that ME EQUIPMENT is intended to receive its power from a separate power supply, it is connected to such a power supply.”

Well the instructions supplied will say this – so where is the inspection and testing indicated?

I have separately been told (this relates to a NB but cannot say anything else) that an approved 60601-1 Power Supply does not in itself guarantee that the “ME System as a whole” will meet requirements you need to provide evidence. The specification of the CE market adaptor indicates:

Conforms to Energy-related Product Directive 2009/125/EC
Approvals: UL recognised, TUV, CCC, CB
Standards: EN 60950-1, UL 60950-1, CSA C22.2

This device provides suction, so other than showing that the amount of suction indicated on the device is a true reading (via calibrated gauges) through bench testing when connected to this adaptor etc – what other evidence am I supposed to be looking for?

Sometimes trying to get your head around standards (especially 60601-1) causes mine to hurt!

Any advice/guidance would be appreciated.

Steve
 
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Peter Selvey

Staff member
Moderator
#2
Re: Separate Medical Device 12V Power Source - What inspection and testing is require

From a regulatory point of view, when using an "off the shelf" power supply (OTSPS), you will need to consider the following areas separately:

- electrical safety
- EMC
- performance (voltage regulation, ripple, noise, surge handling etc)

For: electrical safety, compliance with IEC 60950-1 is most likely OK for your case, assuming you have some intentional separation of the fluid path (patient circuit) and the secondary circuits, rather than have special isolation in the power supply.

For EMC: as long as you test the whole system with the designated OTSPS then it's OK. If you want to use a generic power supply it may need some more detailed argument to justify compliance.

For performance, it is simply a matter of checking compatibility of the power supply specs against your equipment needs. E.g. if the power supply regulation is +/-5%, and your equipment needs +/-10% then no problems. This is no different to using any other part or component. Again if you have a specific OTSPS in mind this is easy, but if you want to use a generic power supply you probably have to build some robustness in your device so it can handle poor quality regulation, noise etc.

For IEC 60601-1:2005, the performance side is not covered except through risk management (e.g. 7.2.5). Electrical safety is covered under Clause 16, which in effect says that IEC 60950-1 is OK. EMC is covered under Clause 17.
 
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