IEC 60601-1 and 60601-1-2 - Not Applicable for My Medical Device

R

rcjpedro

#21
Thanks Marcelo for your time and expertise

The auditor first approach to our TF off site review was to state that it was not a medical device and to stop the audit right there. Because the intended use did not fit the Directive definition. Fortunately I remembered that a CAPA was opened on the first submission of the TF, regarding device classification, to the notified body that mentioned a Consensus Statement that it was indeed a medical device, from here the 28 pages CAPA ensued.

Thanks for this:
If electrical safety requirements would be expected, that standard would have mentioned and required compliance with IEC 60601. It does not.

I will use it. Can you provide any example where a product standard clearly mentions 60601 compliance?
In order to strengthen the argument
 
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Marcelo

Inactive Registered Visitor
#22
I will use it. Can you provide any example where a product standard clearly mentions 60601 compliance?
In order to strengthen the argument
One example would be the ISO 14708 series on active implantable medical devices, the particular standards on that series do call for IEC 60601 regarding electrical safety.

However, I think you are approaching this the wrong way. What I mentioned above is just my experience from using standards.

The correct way to show that IEC 60601 is not applicable is to go back to what I said about the definition of medical electrical equipment and the scope of IEC 60601. This is the only way to correctly justify not applying the standard, showing that the the equipment is out of the scope.
 
R

rcjpedro

#23
Hi Marcelo and thank you for your time.

How could I reply to MDD 93/42

ER9.2
ER12.5
ER12.6?

Reparei que és brasileiro,

Abraço cá de Portugal!
 

Marcelo

Inactive Registered Visitor
#24
How could I reply to MDD 93/42

ER9.2
ER12.5
ER12.6?
This is a different discussion. Your original question was related to how to justify not applying IEC 60601. That's why I focused on the scope of the standard.

Complying with the essential requirements can be done using any option that is deemed acceptable. Using a harmonized standard is only one (but it does give presumption of conformity). You can also use any standard, or even your own standards.

For example, you "could" use the requirement of IEC 60601 to fulfill the ERs mentioned. However, I'm not sure they would be the better solution, as the device is not a medical electrical equipment. A better solution may be using IEC 61010 instead.
 
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