Is IEC 61508 applicable to Medical Devices?



So, I got a note from my boss to investigate IEC61508.

IEC61508 would be very useful to us as we do have some electronic safety related systems, however it seems strange to me that I have not encountered any medical device that is IEC61508 certified (at least they do not advertise it on their brochure).

A quick look at the MDD directive in Europe makes no mention of IEC61508 and it does not seem that the standard has been harmonized by the European community.

Have you ever come across a medical device that has the IEC61508 approval ? Is 61508 mandatory for medical devices ?


Re: Is IEC61508 applicable to Medical Devices

Check the annex C of 62304 where you will find a description of how 61508 relates to this MDD harmonised standard.

Risk is handled differently but 61508 is identified as being useful for recommendations on techniques, tools and methods.


Re: Is IEC61508 applicable to Medical Devices

While 62304 does describe the relationship between 61508 and 62304, it only uses 61508 as a guide for writeup of the standard itself.

Interesting, but I still need to see if there is any regulation somewhere that mandates the use of 61508. Has to be Black on white as they say.


Re: Is IEC61508 applicable to Medical Devices

No you do not have to apply this standard.

You might want to choose to apply it if it has been requested by a customer.


Thank you for your inputs, I have a clearer idea on the regulations now.


We were asked by the notified body (TUV Sud) to submit a Functional Safety Report as per 61508 during the review of TCF, for our class 2b medical device. Wondering how to confront them?

Benjamin Weber

Trusted Information Resource
Not sure, if the problem is still relevant, but I have some input too.

Looking at the scope of IEC 61508-1:2010 in cl. 1.4:
"The horizontal safety function of this international standard does not apply to medical equipment in compliance with the IEC 60601 series."

So, formally the answer is: NO, IEC 61508 is NOT applicable for ME equipment, that is compliant with IEC 60601. (You still might want to apply it, but thats up to you).

I have already heard a few times, that TÜV Süd requires to apply IEC 61508 within testing to IEC 60601 and the manufacturers are always completely confused. Well, they also offer some interesting training and consulting in this area - maybe this is could be some little part in the puzzle ;-)
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