IEC/EN 60601 Testing and CE Marking for a Non Medical Device

[Eamon]

Hello.

I am working at a medical device company.

We are planning to release some products similar to some of our existing medical products, for non-medical use (i.e. for research and education). These products are a set of physiological (mostly electrophysiological) sensors, plus a module that passes the signal from these sensors while isolating them from the (potentially mains-connected) data acquisition system.

The main purpose and the initial motivation for non-medical labelling is to simplify things in the US market, where it's hard to imagine how to pass the device through 510(k) since it has no medical purpose in and of itself. The US market also has rules that ostensibly require some of these kinds of equipment to be sold only under the authority of a health care practitioner, a restriction that is not appropriate for this market.

Since the product in question has electrical connection to a live subject (applied part) and since it includes isolation between the applied part and the mains connected part, we think the most relevant standard to apply is IEC 60601-1. This is as opposed to IEC 61010, which might be another possibility. However, the device is engineered to 60601-1 standards, and if for no other reason than reassuring customers, we would like to show testing to 60601-1. Also, there are competing products which show testing to 60601-1 but are not marketed as medical products.

I would be interested in any helpful comments on this situation, but my immediate questions pertain to CE marking:

• If it is tested to IEC or EN 60601-1, and if the text explaining the CE mark specifies this, does this necessarily imply that it is considered a medical device and therefore falls under MDD?
• If it doesn't have to fall under MDD, what European regulatory scheme would it fall under (having dealt with nothing but medical devices, I know nothing about non-medical CE marking)?
• What else regarding CE marking might I need to look into, in this situation?

Thanks in advance to anyone who can help me with answers, or give me pointers on where to look for them.

Eamon Egan

 

[Marcelo]

If it is tested to IEC or EN 60601-1, and if the text explaining the CE mark specifies this, does this necessarily imply that it is considered a medical device and therefore falls under MDD?

The way that the new approach directives such as the MDD are designed is to rely on the information supplied by the manufacturer regarding the products.

So, MDD is applicable to medical devices, and

medical device means any instrument, apparatus, appliance, software, material or other article, whether used alone or in combination, including the software intended by its manufacturer to be used specifically for diagnostic and/or therapeutic purposes and necessary for its proper application, intended by the manufacturer.....

So, in principle, if you do not intend your device to be used for medical purposes, yor device does not fall under the MDD.

This same "directive design" has a built-in function of using standards to provide conformance. Although harmonized standards can be used to provide presumption of conformity, in fact you can use any standard that you see fit (but they do not give presumption so you need some kind of justification).

This is to say that being in conformance with a standard does not mean the product fall under a directive.....so no, there´s no implication here....in truth, it´s the other way, equipment under a directive CAN be in conformance with a particular standard harmonized to this directive.

This is all true from a theoretical point of view, but keep please in mind that interpretations on this could vary.

If it doesn't have to fall under MDD, what European regulatory scheme would it fall under (having dealt with nothing but medical devices, I know nothing about non-medical CE marking)?

You need to take a look at the directives of the EU, in lists such as the one from the New Approach website and the EU website (more complete).

Things for a fresh start: EMC directive, RoHS, WEEE, General product safety directive, Low Voltage directive

What else regarding CE marking might I need to look into, in this situation?

I think it would be best to have an official position, for example, from a notified body or the regulatory authority of your country, due to this being an unusual situation.

 

[TamTom]

Hello,

CE marking is independ from medical devices.

Every "machine" whit "moving" parts, must have such a marking.

I attached, the EU legal text for this, it is not easy to read.

Regards,

TamTom

 

[chris1price]

Hi

We are in a similar position of having a "Medical Device" which is not covered by the MDD. I would suggest the EMC and LVD directives as a start. Check the Machinery Directive is applicable as well.

Chris

 

[Eamon]

Thanks to all who replied. I will read through the LV and and EMC directives to see how they are structured, and to be sure I understand how 60601 compliance can generate a presumption of conformity to these directives (versus the MDD).

- Eamon Egan

 

[Marcelo]

I understand how 60601 compliance can generate a presumption of conformity to these directives

IEC 60601 cannot give presumption of conformity to those directives as it´s not harmonized under them.

But that does not mean you cannot use it to show conformity to the essential principles of those directives.

 

[Eamon]

IEC 60601 cannot give presumption of conformity to those directives as it´s not harmonized under them.

But that does not mean you cannot use it to shoe conformity to the essential principles of those directives.

Thank you for this distinction.

What I take this to mean is that the Technical File should contain some justificatory language as to why our 60601 test results results imply conformity with LVD and EMC. For example, list the different areas, note that the requirements are at least as stringent...

Does this sound like a reasonable approach?

- Eamon

 

[Marcelo]

What I take this to mean is that the Technical File should contain some justificatory language as to why our 60601 test results results imply conformity with LVD and EMC. For example, list the different areas, note that the requirements are at least as stringent...

Does this sound like a reasonable approach?

Yes, that´s what i think you need to do. Note that another good justification is that, even not being intented to be used as a medical device, IEC 60601 seems to be the closest standard to use in terms of engineering design (at least from what you told us)...and surely is more stringest in general than other electrical devices standards.

 

[schwatzi]

Hi I was wanting to know if you knew any websites that could help me, I was wanting to set up IEC 60601 testing and wanted to know the equipment required for leakage current measurements and HV tests etc, I do have other equipment as I work in a Test lab.

 

[TamTom]

Hey, testet

this kind of stuff:

http://www.601help.com or this

http://iec60601.com/

Greetings

TamTom