Can the IEC 60601 standard be applied?

Harol

Registered
Hello again colleagues,

Do you know if it is possible to certify a product under IEC 60601 without it being a medical product?

I mean, the product has no patient applicable parts, nor is it connected to a patient, should we use another standard, maybe IEC 61010 seems more appropriate?

The equipment has a single 230V main power connection and has a motor running at this voltage. The electronics run at 24V.

The initial thought is that as long as the equipment is able to pass all the tests in IEC 60601, it should be certifiable to IEC 60601.

Your comments would be much appreciated.

Thanks in advance,

Merry Christmas!
 

mr9000

Involved In Discussions
IEC 60601-1 is applicable to
electrical equipment having an APPLIED PART or transferring energy to or from the PATIENT or
detecting such energy transfer to or from the PATIENT and which is:
a) provided with not more than one connection to a particular SUPPLY MAINS; and
b) intended by its MANUFACTURER to be used:
1) in the diagnosis, treatment, or monitoring of a PATIENT; or
2) for compensation or alleviation of disease, injury or disability

It is not applicable to NON ME-Equipment AND
– in vitro diagnostic equipment that does not fall within the definition of ME EQUIPMENT, which
is covered by the IEC 61010 series [61];
– implantable parts of active implantable medical devices covered by the ISO 14708
series [69]; or
– medical gas pipeline systems covered by ISO 7396-1 [68].

I can have a stopwatch which 60601-1 is applicable to, when I say its purpose is to measure the time between inhaling and exhaling to determine a breathing rate. I can have the same product which is 60601-1 is not applicable to, when I say its purpose is to measure the time of a race.
What is the intended purpose of your device?
 

Harol

Registered
@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.
 

Swimming In The Soup

Involved In Discussions
61010 is better for your device. It will most likely be used in a laboratory setting.

Look at 1.1.1.c in the second image for your device.
 

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Peter Selvey

Leader
Super Moderator
It not unusual for companies and even agencies to use IEC 60601-1 even though it is not the correct standard, partly due to familiarity and partly due to concerns that it will be better for sales and marketing (since purchasers often don't know the scope details, and often assume if it's used in a hospital near patients, it should IEC 60601-1).

However, there are risks in this approach, in particular associated with insurance and liability. Even if an incident has nothing to do with using the wrong standard, insurers may refuse to pay out if they find out. Any kind of contract or agreement that may include a standards compliance as a condition could be challenged if the wrong standard is used. And the correct standards e.g. IEC 61010-1 or IEC 62368-1 may be better suited and cover special aspects that are not covered by IEC 60601-1.
 

CharlieUK

Quite Involved in Discussions
Before looking at the standard you must consider the Directive as compliance must be done "top down" from the Directive and Regulations

The equipment has a motor, so will fall under the Machinery Directive unless exempted as per Article 1(2) and from what you've said so far, I don't think it will be.
 

DanMann

Quite Involved in Discussions
61010 is better for your device. It will most likely be used in a laboratory setting.

Look at 1.1.1.c in the second image for your device.
And in case it comes up - even if it is not used in a lab environment, IEC 61010 can be applied (look at attachment 2, part c).
 

Benjamin Weber

Trusted Information Resource
Before looking at the standard you must consider the Directive as compliance must be done "top down" from the Directive and Regulations

The equipment has a motor, so will fall under the Machinery Directive unless exempted as per Article 1(2) and from what you've said so far, I don't think it will be.
I would challenge the conclusion that every motor in a device will make machinery directive applicable. What about a device with an internal motor driving a cooling fan?
 

CharlieUK

Quite Involved in Discussions
I would challenge the conclusion that every motor in a device will make machinery directive applicable. What about a device with an internal motor driving a cooling fan?
It depends on the overall product - if the product is not included in the list of exemptions in MD article 1(2), then strictly speaking it's within scope of the machinery directive as it's not exempt.
 
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