IEC EN 60601-1-4 vs. IEC EN 62304:2006 Gap Analysis?

Hi All,

Hoping that someone out there has had the same dilema as I currently have...?

Our medical device is powered by an RF Generator with software that was developed in accordance with 60601-1. Our Audior (BSI Technical Audit) stated that we should be in accordance with "62304:2006.

I have a copy of 62304 and in the back, there is a Table(C.4) that states the relationship between 60601-1-4 and 62304...but, it just sites numbers...

So, has anyone actually gone through and actually compared one to the other? It appears to me, just by running down the list, that the old Std. 60601-1-4 is more inclusive than the new one. Why would the new Std. be less than the old one??

Any help, especially a gap analysis of any sort, would be greatly appreciated!

The table in 62304 will guide you. Have you looked at the list of 62304 sections missing from the comparison to 60601-1-4? That's what you need to add and may already be in your work.

glork98 said:

The table in 62304 will guide you. Have you looked at the list of 62304 sections missing from the comparison to 60601-1-4? That's what you need to add and may already be in your work.

Click to expand...

Thanks Glork98!

Ok, so... where do I find that list of sections missing from 62304? Did I state that correctly?
What I mean is... Is 60601-1-4 MORE inclusive or less? If the device was designed and built to 60601-1-4 then, by default, it already complies to 62304? I think I have this backward?
Anyway, I need the list...?!!
Thanks again!

peter_traina said:

Ok, so... where do I find that list of sections missing from 62304?\

Click to expand...

You think this would be commonly needed and "out there" for loading.

The problem is that there's overlap but one is not a proper subset of the other.

Take this checklist and mark off each row that's listed as being in 60601. Then classify your software (A, B or C) and the un-marked rows for that class are the ones you need to cover. 62304 is mostly common practices so chances are you'll have it covered or can with a modest amount of additional work.

One key difference is that IEC 60601-1-4 is focused primarily on critical safety systems, while IEC 62304 is applicable to all software no matter how simple the function.

For an RF generator, it's likely that you will have two or three key safety systems: e.g. the protection system which prevents excess power in fault condition, for monopolar systems neutral electrode monitoring circuit, and protection against faulty or unintended release of RF energy. Such protection systems would be the focus IEC 60601-1-4.

Such safety systems should be carefully specified, broken down into modules (units), with unit verification, integration and system testing according to both IEC 60601-1-4 and IEC 62304, with no excuses.

But, under IEC 62304, all software functions have to be included. It's possible that many software functions can be treated simply, if they are not so critical. Even so, you cannot avoid at least a high level spec and high level verification of all software related functions, even something as simple as turning on the blue light when the operator selects the cut mode, or the software function that prevents the operator from selecting more than 120W in coag mode.

Just to be clear, 62304 is not a replacement for 60601-1-4 (now clause 14 of 60601-1: 2005). 62304 addresses the details of the software development lifecycle. 60601-1-4/Clause 14 of 60601-1 addresses the development of Programmable Electrical Medical Systems (PEMS). The PEMS standard is a systems development document and applies only to hardware/software integration (systems). 62304 only addresses the development and post production support of software. There is currently an Amenedment to 60601-1: 2005 under development that will require the use of 62304 to address the softaware lifecycle.

The original -1-4 did provide some very general descriptions of the aspects a software development lifecycle should have but implementing 62304 in replacement of the PEMS requirements will leave significant gaps unaddressed. The annex referred to shows how the two sets of requirements overlap and a close examination will clearly indicate the areas of -1-4/Clause 14 that 62304 does not address.

Hello Peter, I am interested in the final results of your 60601-1-4 versus 62304 GAP Analysis and how you were able to successfully resolve the BSI Technical Audit with respect to your RF Generator software being compliant with 62304. I am working with a client (I am a consultant), collecting options for them (they are in the same boat with another type of device) and would like to understand how you resolved this. Thank you.