IEC 60601 for Non-Medical Research Purpose Devices

Q

Qara5

#1
Hello! This is my first post so I hope someone can help me.

At my company we sell a medical device into many markets including the EU and US. We are CE marked in the EU and FDA approved in the US. We tested to 60601 on the recommendation of our NB (As an aside I'm not 100% convinced this was correct as whilst we are definitely medical equipment we are never in the vicinity of the patient so maybe 61010 would have been more appropriate).

We are now looking to sell the same device into the life sciences market. Outside a medical setting our device would appear to be laboratory equipment. So my question is this - does our 60601 testing cover our medical device for non-medical research purposes or do we need to retest it against 61010?
 
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K

KTcons

#3
I think that a comparative analysis between the two standards could be sufficient: requirements of EN 60601 should be more restrictive...
:cfingers:
Katia
 
S

Spazz

#4
I agree with KTcons that a comparative analysis between the two standards should be enough. Essentially you'd be performing a gap analysis on data that's missing for 61010.

But before you get that far...

At my company we sell a medical device into many markets including the EU and US. We are CE marked in the EU and FDA approved in the US.
...
We are now looking to sell the same device into the life sciences market. Outside a medical setting our device would appear to be laboratory equipment.
For CE Marking at least, I'd double check which directive(s) would apply now that the market (and intended use, I assume) has changed. 61010 may not be applicable for that directive.
 
Q

Qara5

#5
Many thanks both for your replies.

I'd double check which directive(s) would apply now that the market (and intended use, I assume) has changed. 61010 may not be applicable for that directive.
Good point! I shall look into that.

Whilst we are in the topic - we have a lot of circular discussions in our company about whether we even need 60601 or if 61010 would be sufficient for our MDs. Some people's opinion is that it is a medical device therefore must have 60601. Others feel that 60601 should only apply to a device that is in the vicinity of the patient which ours is definitely not. The information online seems to mirror this - I can't find anything definitive and it seems very open to interpretation. Our notified body sent us down the route of 60601 but I notice that competitors products are only 61010! Would be interested in the opinions of other forum users.
 
S

Spazz

#6
Whilst we are in the topic - we have a lot of circular discussions in our company about whether we even need 60601 or if 61010 would be sufficient for our MDs.
We were in a similar situation not long ago at my company and the participants on this forum were very helpful in pointing out that it all depends on whether or not the device met the scope of the standards (Sec. 1 which usually is available for free preview). That said, if your NB is asking for a specific standard, you probably have very little choice...
 

Pads38

Trusted Information Resource
#7
Directives versus standards!

EN 60601 is a harmonised standard under the medical device directive EEC/93/42 (MDD).

EN 61010 is not.

That means that you would have a very difficult time in persuading a notified body that testing to EN61010 shows that the Essential Requirements of the MDD have been met.

Notified Bodies assess your device and Technical Files to the requirements of the MDD, not standards.
 
Q

Qara5

#8
Directives versus standards!

EN 60601 is a harmonised standard under the medical device directive EEC/93/42 (MDD).

EN 61010 is not.
Thank you! That is very helpful. I think I am starting to understand after reading these responses and some similar posts on this forum. So for our medical devices we must conform to the MDD. 60601 is the harmonised standard under that so shows that me meet the essential requirements of the MDD. For our non-medical devices the MDD no longer applies so 60601 will no longer imply compliance but we can still use it with some justification. Please correct me if I've misinterpreted and thanks again for all the help!
 
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