CE Mark for Dental Imaging Software

[Micked]

Dear forum members,

I am a newborn medical device quality consultant. My background is 15 years in R&D with Siemens Medical in Sweden.

My client makes a software package for importing, viewing, enhancing and storing images from dental X-ray systems or intra oral cameras.
They have a very flexible interface scheme, so there are a lot of image sources. Everything regarding X-rays and hardware is outside of the scope.

They feel the magic date of 3/21/2010 approaching so the march to the CE mark has started.

This is a *very* small company, so I try to streamline all procedures as much as I can. My mantra is: "Cover everything, but wafer thin".

I am working with the client to cover what I call the basic package for the essential requirements:
ISO 13485 Quality system
ISO 14971 Risk management
ISO 62304 Software lifecycle
IEC 62366 Usability

After this rather long preamble comes my question:
Is there any particular standard, imaging-related, that they have to cover?

I got my eyes on these two:
IEC 60601-2-54 Particular requirements for the basic safety and essential performance of X-ray equipment for radiography and radioscopy

IEC 61223-2-5 Constancy tests - Image display devices

Are they relevant at all?

Is there anyone in the forum with experience from a similar system?

To summarize, I do not want to give my client a list of all remotely applicable standards, only what they really have to fulfil.

As a bonus, your feedback will be used as ammunition against my notified body, he didn't seem to sure about this topic either.

Thanks
Micke

[Marcelo Antunes]

60601-2-54 is a standard for the equipment, not the software. But if the software is to be used with a medical electrical equipment, it might be necessary to use portions of EN 60601-1:2006 (clause 14 on programmable medical electrical systems) or EN 60601-1-4:1996.

Series 61223 is for tests. The manufacturer can use, during development, any standard on this series that is applicable that he wishes, but keep in mind that they are no harmonized, so there´s no presumption of conformity.

There are other general harmonized standards for medical device which are applicable to all medical devices (for example, EN 1041:2008
Information supplied by the manufacturer of medical devices), but you´ll have to figure out from the list what is applicable in each particular case.

[Micked]

Marcelo,

Thanks for the feedback on the X-ray standards. I don't want to buy them just to see that they don't apply to me...

Your comment about 60601-1 is interesting. It is my, and my notified body's, opinion that a pure software product need only conform to my "basic package" listed in the first post. That is why I omitted 60601-1-4 (which I reviewed in my former life, and I was probably one of the first to apply it...), and instead opted for 62304.

62304 has, in my opinion, a very good approach to SOUP. And since it is recognized by the FDA, I am counting on using it for a 510(k) without having to go through the different FDA software validation guidelines.

I think this is a problem of general relevance to this forum:
System one (software only) interfaces to system two via a defined interface. How much of system two regulatory requirements will "spill over" to system one?

In my (dental) case there is one good example. The software manufacturers *recommend* users to use high quality monitors to view X-ray images. This is probably very rare in private dental practices due to economic reasons.

The whole dental software area seems to have lived outside the "regulated life" that at least I am used to. Any comments?

/Micke

[Marcelo Antunes]

a pure software product need only conform to my "basic package" listed in the first post

Generally, I agree with the way you´re thinking, and i think this might be the case for your software, as it seems to be a medical dvice in it´s own, not a part, for example, of a medical electrical equipment. Anyway, i just said that to remind people which reads the post. Also, take a look at my comment below.

That is why I omitted 60601-1-4 (which I reviewed in my former life, and I was probably one of the first to apply it...), and instead opted for 62304.

Please note two things: first, IEC 62304 dows not replace IEC 60601-1-4 or the PEMS requirements of IEC 60601-1:2005. In fact, they are complimentary. Also, even if your software is not used with a medical electrical equipment, it might be interesting to use these requirements for a tighter control (for example, there are some requirements for data coupling in 60601-1 which are not present in 62304 - and this is one of the exemples of the spill over you cited).

Also, and this i my own opinion..if your notified body agrees with an action, i would recommend doing more than that.

[Micked]

After having discussed with two different notified bodies, I have come to the conclusion that no particular standards apply to a dental imaging software package.

Over and out!

[Marcelo Antunes]

Great, thanks for the update.