EN 62304:2006/AC:2008 vs IEC 62304:2006/Amd 1:2015

[lennsy]

Hello,

I would like to ask you for support when it comes to understanding EN and IEC standards. Since we have IEC 62304:2006/Amd 1:2015, how does it correspond to EN standard which is already obligatory (EN 62304:2006/AC:2008)? The mentioned IEC standard is the most updated version of this standard and generally EN revision should implement relevant changes which appeared in revision from 2015?

Thank you in advance.

 

[Ronen E]

Hello,

I would like to ask you for support when it comes to understanding EN and IEC standards. Since we have IEC 62304:2006/Amd 1:2015, how does it correspond to EN standard which is already obligatory (EN 62304:2006/AC:2008)? The mentioned IEC standard is the most updated version of this standard and generally EN revision should implement relevant changes which appeared in revision from 2015?

Thank you in advance.

EN 62304:2006/AC:2008 (or any other EN standard, for that matter) is not obligatory. It's not even harmonized under the MDR yet (IEC 62304:2006/Amd 1:2015 is mandated to be harmonized by 27 May 2024, in the M/575 Decision); for what it's worth, it's harmonized under the MDD though.

More generally, there's no blanket "should" about EN standards. It's a mix of specific circumstances surrounding each standard, and a good pinch of politics. Whatever any given standard version ends up being done with is highly specific - you should look at what the actual update contents are and what consequences they carry, to try to understand what's going on between the Commission and CEN/CENELEC around it.

In the specific case you brought up, A1:2015 to IEC 62304:2006 added provisions for dealing with Legacy Software = software already legally placed on the market, yet lacking sufficient objective evidence of IEC 62304-compliant development (software predating the standard); and introduced a risk-based approach to the software safety classification to enable these added provisions. If your SW doesn't fall in this category, just write off A1:2015 changes as N/A and declare compliance with EN 62304:2006/AC:2008 if it assists your cause.