Is computing Hardware part of the IVD

#1
We're building a Whole Slide Scanner, intended to be used as an IVD. The scanner however operates together with a PC (On which the software runs).
The software will be classified as an IVD and needs to follow regulations pertaining to the same, my doubt however is whether the PC needs to be classified as an IVD too? If not, how do we conduct EMI/EMC and Safety Tests without the PC causing interference in those tests?
 
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Benjamin Weber

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#2
In my oppinion the computer is not part of the IVD, even though it is used together with it.

IEC 61010-1 says:

1.1.3 Computing equipment
This standard applies only to computers, processors, etc. which form part of equipment within
the scope of this standard or are designed for use exclusively with the equipment.

NOTE Computing devices and similar equipment within the scope of IEC 60950 and conforming to its
requirements are considered to be suitable for use with equipment within the scope of this standard. However,
some of the requirements of IEC 60950 for resistance to moisture and liquids are less stringent than those in this
standard (see 5.4.4 second paragraph)).
(OK, IEC 60950 is more or less obsolete, but then IEC 62368 would be the right choice.)

Your PC is an off-the-shelf device and not exclusively designed for your IVD? Do you even have the PC included or are you offering the IVD with the software and the end user can use any PC?

Regarding EMC: I would directly ask an accredited test lab for IEC 61326), if it is sufficient to have the corresponding EMC conformity proof for IT equipmnet for the PC and how the PC would be taken into account during testing of the whole slide scanner.
 
#3
Thanks Benjamin for the clarification!
The PC is an off the shelf device, but the software cannot be installed off the cloud/media sticks. There are certain hardware and operating system/environment restrictions which is why we install the software on the PC and then ship it with the scanner.

I have asked an accredited lab, but they weren't aware of the particular requirements, do you have any in mind which could provide us the right guidance?


In my oppinion the computer is not part of the IVD, even though it is used together with it.

IEC 61010-1 says:



(OK, IEC 60950 is more or less obsolete, but then IEC 62368 would be the right choice.)

Your PC is an off-the-shelf device and not exclusively designed for your IVD? Do you even have the PC included or are you offering the IVD with the software and the end user can use any PC?

Regarding EMC: I would directly ask an accredited test lab for IEC 61326), if it is sufficient to have the corresponding EMC conformity proof for IT equipmnet for the PC and how the PC would be taken into account during testing of the whole slide scanner.
 

Benjamin Weber

Trusted Information Resource
#4
I am sorry, but I cannot recommend a particular lab.

But I just had a look at scope if IEC 61326-1, which says:

Computing devices and assemblies and similar equipment within the scope of information
technology equipment (ITE) and complying with applicable ITE EMC standards can be used in
systems within the scope of this part of IEC 61326 without additional testing, if they are
suitable for the intended electromagnetic environment
I don't have the whole standard (the quote is from a preview only). But you should have a look at the electromagnetic environment definitins of the standard and than deceide wether your PC is suitable for your intented environment.
 
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