Can the IEC 60601 standard be applied?

Peter Selvey

Leader
Super Moderator
It's been a while but I do remember the Machinery Directive, when it was new, took everyone by surprise when medical devices were not excluded. Ultimately, I believe it worked out that if the "usual" harmonised standard (e.g. 601, 1010) includes appropriate stuff to address mechanical risks, it was basically OK and mainly ended up being an additional line in the the EU declaration of conformity. Legally, it was really up to the member states to make sure the standards took into account anything special from the Machinery Directive and communicate/clarify this through the use of Annex Z. Not sure if this is the current interpretation.
 

CharlieUK

Quite Involved in Discussions
In the old Machinery Directive 98/37, only the machinery where “the risks are mainly of electrical origin” shall be covered exclusively by Low Voltage Directive - so the decision as to whether or not a product was within scope of the Machinery Directive was dependent on the risk assessment made by the manufacturer.

The 2006/42/EC Directive does not allow this "Risk Assessment" approach to determine whether or not a product is within scope.

Of course, it is always up to the manufacturer to decide on the Directives applicable to their product and demonstrate compliance with the applicable Directives in their Technical File.
 

Al_Z1

Involved In Discussions
According to p.12 article 1 of MDR:
"Devices that are also machinery within the meaning of point (a) of the second paragraph of Article 2 of
Directive 2006/42/EC of the European Parliament and of the Council (1) shall, where a hazard relevant under that
Directive exists, also meet the essential health and safety requirements set out in Annex I to that Directive to the extent
to which those requirements are more specific than the general safety and performance requirements set out in
Chapter II of Annex I to this Regulation."
There is the same statement for MDD, I just don't remember specific point.
Well, I used gap analyse of the whole annex I of MDD (at that time it was MDD needed for CE sertificaton) with supplementing IEC 60601 etc. standards and Annex I of Machinnery directive with explanations, wether specific requirements from these annexes are applicable to my device. So, if the requirements needed, were covered by MDD and medical standards, I stated, that this is enough for the device, if no, than I used additional risk assesment or tests to supplement requirements from Machinnery directive. Happily for me, there were only two points of Machinnery directive, which were applicable to my device and not overlapped by MDD and medical standards, and I just needed to them into akkount in RMF.
This approach was ok for NB at our time of certification (late 2021).
 

Enternationalist

Involved In Discussions
@mr9000 thanks for the quick response.

It is because of the sections of the standard that you have mentioned that I am inclined to believe that it cannot be applied.

The system does not contain equipment that has a part applicable to any patient.

It basically prepares concentrate used in the dialysis fluid.

It could be argued that the system is connected to another system that performs dialysis, but it would really be this second system that would have a part applicable to the patient.
I would be careful with this interpretation. There are devices with no applied parts that fall under the scope of the standard - for instance, chemical or mechanical energy can be considered. See also NOTE 1 to 3.63, which includes accessories necessary to enable normal use of ME EQUIPMENT. I don't know enough about your device, but the reasons you've given alone wouldn't make me certain that it isn't in-scope.
 

Harol

Registered
I would be careful with this interpretation. There are devices with no applied parts that fall under the scope of the standard - for instance, chemical or mechanical energy can be considered. See also NOTE 1 to 3.63, which includes accessories necessary to enable normal use of ME EQUIPMENT. I don't know enough about your device, but the reasons you've given alone wouldn't make me certain that it isn't in-scope.

Hello again,

After acquiring and reviewing some standards, ISO 23500 and IEC 60601-2-16 I don't seem to find a justification for the use of IEC 60601. ISO 23500-4 points towards IEC 61010. However, I would like to bring back the initial question, would it be possible to certify the product under IEC 60601 by simply passing the applied regulatory tests?

Finally the system will be installed in a hospital or clinic and the concentrate liquid is connected to the patient, the installations are centralised, we could even say that it is a MEE that is connected to a MES.

What do you think?

Thank you all for the answers, at least there seems to be a topic for discussion.
 

mr9000

Involved In Discussions
Why would you want unneccessary (expensive) certification for a standard your product is not applicable to?
It is not only the applied regulatory tests regarding electrical and mechanical safety, which I'm sure can also be found in 61010 (with lower requirements) - what about the whole documentation?
 

Harol

Registered
Why would you want unneccessary (expensive) certification for a standard your product is not applicable to?
It is not only the applied regulatory tests regarding electrical and mechanical safety, which I'm sure can also be found in 61010 (with lower requirements) - what about the whole documentation?

If a customer wants his product to be certified under a specific regulation, say 60601, it is not a question of cost, the question is whether it is possible to certify products under the specific regulation, there is no problem to generate the documentation, which is cumbersome and elaborate.
 

CharlieUK

Quite Involved in Discussions
Stepping back a moment to the regulatory requirements.
The legal responsibility to determine which Directives are applicable to a product and which standards are used to demonstrate compliance with those Directives rests solely with the manufacturer.

The customer has a right to product that is compliant with appropriate Directives.
If a customer thinks a particular standard is applicable to a product, and that was different to what I determined as a manufacturer, I would ask them to explain why they think it is applicable starting with which Directives are applicable.
 
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