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IEC 62304:2015 vs IEC 62304:2006 + AMD1

blah01

Involved In Discussions
#1
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.
Dave
 

yodon

Staff member
Super Moderator
#2
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
#3
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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