DIN EN 62304

[hanna rotermund]

This year the software norm DIN EN 62304 is required for our product.
Is there any effort on your side to fulfill this?
Greetings, Hanna

[Jörg Riesmeier]

DCMTK is a free and open source software that is available under a BSD-style license. If you are using it for medical products, it's up to you to fulfill the legal requirements. Of course, the DCMTK can be used and is actually used by various companies both for medical products and for other purposes.

If you need more details, you should probably send us an email (dicom/at/offis/dot/de).

[Per]

You would typically classify DCMTK as a SOUP item under EN/IEC 62304. See 3.29, 5.3.3/4, 7.1.3 and 8.1.2 in the standard. It is the responsibility of the manufacturer to validate a SOUP item. There are things, though, that Offis could do that would help immensely for such validation, such as publishing an updated list of known issues and allow public access to DCMTK's version control history.

[Michael Onken]

Hi Per,

indeed we have a list of known issues, though it is not very up-to-date regarding the snapshot (e. g. the current problem in OFString). We could/should extend that to the snapshot versions.

Right, we don't have our version control logs publicly available, but any change to DCMTK is listed in the CHANGES file shipping with the source code; however, this is not sufficient because you would have to do manual diffs to see what exactly changed?

Regards,
Michael

[Per]

I did not know about that list. Well, at least that is a good start. Thanks

The list is incomplete, though. Several other issues have been discovered, for instance on this forum. I currently maintain my own list of known issues for 3.5.4 relevant for our own use of DCMTK that is based on public discussions. See https://gna.org/projects/pdcmtk/ for that list and fixes for them. It would be nice if we could merge those lists.

[Jörg Riesmeier]

With regard to "public access to DCMTK's version control history" there is an update: We are currently testing a mechanism that would make the DCMTK repository publicly available (read-only access). As soon as it is available, we'll post an announcement and also add a description to the Wiki.

[Oliver Nix]

There are two downloadable reports that deal with the use of SOUPs in medical / critcal software.

"Justifying the use of software of uncertain pedigree (SOUP) in safety-related applications"
and
"Methods for assessing the safety integrity of safety-related software of uncertain pedigree (SOUP)"

They can be found here:
http://www.adelard.com/web/hnav/resourc ... _soup.html

For a start they provide some useful thoughts.
In the end the question whether it makes sense or even if it is possible to use a certain SOUP depends on the SOUP and the risk classification of the software components involved.