IEC 60601-1 and Essential Performance

[Kunal Deshpande]

Hi All,

I refer the some of the test reports of IEC 60601-1 they mention as ESSENTIAL PERFORMANCE (clause no. 4.3) is Not applicable. how its possible that ESSENTIAL PERFORMANCE is not applicable.

 

[yodon]

Essential performance does not equate to functional performance.

The definition of essential performance in 60601-1 terms is:

performance necessary to achieve freedom from unacceptable RISK

They include a follow-on note:

ESSENTIAL PERFORMANCE is most easily understood by considering whether its absence or degradation would result in an unacceptable RISK.

If a device fails to meet one of its functional specification but in doing so it does not result in an unacceptable risk, it's not essential performance.

 

[Kunal Deshpande]

Thanks Yodon for the reply, but still i am not understand correctly for e.g. if any ECG lead failed in functional performance the diagnose will not be correct in this case ESSENTIAL PERFORMANCE is applicable or N/A.

 

[Kunal Deshpande]

Essential performance does not equate to functional performance.

The definition of essential performance in 60601-1 terms is:

performance necessary to achieve freedom from unacceptable RISK

They include a follow-on note:

ESSENTIAL PERFORMANCE is most easily understood by considering whether its absence or degradation would result in an unacceptable RISK.

If a device fails to meet one of its functional specification but in doing so it does not result in an unacceptable risk, it's not essential performance.

Thanks Yodon for the reply, but still i am not understand correctly for e.g. if any ECG lead failed in functional performance the diagnose will not be correct in this case ESSENTIAL PERFORMANCE is applicable or N/A.

 

[yodon]

It's up to you to decide. If the lead fails, does it lead to unacceptable risk (by however you define that)?

(To be perfectly honest, I struggle with this as well so I understand your frustration.)

It sounds like your test lab agreed that there was none. They usually push back (quite hard) if they believe otherwise.

 

[gyiszu]

Hello Kunal!

Lot of Time it happens that the device does not have EP. When it has EP it is usually associated with the output or a measured value, which usually covered by clause 12. If you have a particular standard it might define EPs, in my opinion it helps a lot if you check few particular standard for EPs so they will help
You identify functions the absence of which result in a hazardous situation. If you find such than you can cross-check with the manufacturer so he will give you explanation if it is EP or not.

If you have ECG -2-25 or -2-27 or -2-47 will define you EP so N/A is not correct verdict.

BR

Gyiszu