IEC 60601-1 Cl. 14 - Report changes in Software after Testing to Test Lab?

S

Spazz

#1
Hello!

Regarding Cl. 14 PEMS in 60601-1 3rd Ed., I'm confused as to what would happen if the software is modified or improved upon after testing is done (and a test report is issued). If we follow the requirements, the documentation would be revved up from ones that were inspected.

What sort of changes, if any, need to be reported to the test lab? And what would trigger a retest or re-review of documentation?

I can't seem to find any guidances on this. Has anyone encountered this situation before? I'm assuming that everyone continues working on software after product is released (though I may be wrong :D)...

Thanks,
B
 
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W

wally4u

#3
Assuming by testing you mean external test house:

In my experience any changes that are made that change the functionality (for better or worse) of the device require retesting.
Cosmetic changes would not require retesting, with the exception if the human interaction changes (i.e. major changes in the IEC 60601-1-6 USABILITY ENGINEERING PROCESS)

Changing a typo in the text would require retesting internally to verify and validate the system again, but IMHO no external lab retesting
Also take a look at the IEC 62304 since you are talking about software, in chapter C there is a good explanation how software relates to the IEC 60601-1.

Any changes you made would require you to update the Risk Management Plan with the accompanying Risk analysis to see if your change have any effect on the safety of the device. Hence software changes will always require you to do a documentation review/update.

We retest our entire device every time we create an software update that goes outside of the company, with the accompanying load of paperwork, hence it doesn't happen very often.
 
S

Spazz

#4
Thanks for your insight, wally4u.

I think the confusing thing is that it seems the IEC 60601-1 requirements for PEMS software are based on a development process rather than actual product. I understand the need to retest if, say, I change a safety critical component, but software is constantly being improved upon even after test and release. So even if the software changes drastically, as long as the software development process is still in place, I can't see the test lab finding fault as per Clause 14...which doesn't sound right to me.

We have standalone software as well, so we're working within IEC 62304. I'll reread it more carefully.

Happy spring (in the Northern Hemisphere)!
 
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Peter Selvey

Staff member
Super Moderator
#5
A test report is a one time snap shot of a the sample provided to the lab, it is not on its own a the full evidence of compliance in design and production.

On the regulatory side, if a manufacturer includes a test report in a technical file, there is always a supplementary requirement to ensure that the results are representative of the actual product that goes to market. Many changes can happen between the test and product release, and also after release. Change handling is complex subject, and very much case by case decision depending on the change. In most modern regulations there is no requirement for third party testing, so the change evaluation can be handled in-house. You can seek outside help if that makes sense (e.g. your company lacks the equipment or know how for the particular tests), but it is entirely up to the manufacturer to decide.

For PEMS requirement, it is quite possible that the test house did not add much value anyway, just rubber stamping your documents without any sense of responsibility. This is not the test lab's fault: they are being basically forced to write reports covering PEMS, and the engineers involved would happily exclude it if they could. In this case, it makes little sense ask for an updated test report. However, if the test lab really looked into the critical areas and provided value added assessment (with true responsibility and technical competence), you certainly leverage that capacity as a double check before going to market.

In product certification (e.g. NRTL mark) the agency's responsibility also extends to regular production. However, NRTL marks are usually restricted to "shock, fire, mechanical", i.e. basic safety. If the PEMS is used as a risk control for basic safety (e.g. a software controlled interlock to prevent mechanical injury) , and a change is made, then reporting to the certification agency would be required. However, if the PEMS is out of the scope of the NRTL evaluation, then no reporting is required.

If your product certification covers full scope (e.g. an Annex III certificate in Europe) then reporting of all changes is required, unless it is obviously cosmetic and has no effect for performance, intended purpose, clinical application or safety in anyway.
 
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