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IEC 62304:2015 vs IEC 62304:2006 + AMD1


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I currently have IEC 62304:2006 plus IEC 62304:AMD1 and wondering if I need to purchase IEC 62304:2015 at all given it's not cheap. Therefore would anyone know if 62304:2015 has anything additional/different compared to 62304:2006 + 62304:AMD1?

Thanks in advance.


Staff member
Super Moderator
Probably the biggest single change is the addition of how to handle legacy software.

Many of the changes are just wording tweaks but there are a lot of other changes that are more substantial but far too detailed to list.

If I recall, you may be able to buy a copy of just the changes at less cost.

Ronen E

Problem Solver
Staff member
Super Moderator
There is actually no "IEC 62304:2015" as such; only IEC 62304:2006/Amd1:2015. You can buy a consolidated version though, which is ridiculously expensive, and that's probably what you were referring to. But it's not a new standard and doesn't have any content beyond Amd1.
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