IEC 62304:2006/AMD1:2015 Changes for Class A Software

blah01

Involved In Discussions
#1
My company is just starting to implement IEC 62304 for a Class A stand alone software, and I noticed that there was an amendment released in June 2015. Would anyone know if any of the Class A requirements were modified/added?

Thanks in advance.
 
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Pads38

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#2
INTRODUCTION to Amendment 1
The first edition of IEC 62304 was published in 2006. This amendment is intended to add requirements to deal with LEGACY SOFTWARE, where the software design is prior to the existence of the current version, to assist manufacturers who must show compliance to the standard to meet European Directives. Software safety classification changes needed for this amendment include clarification of requirements and updating of the software safety classification to include a risk-based approach. Work is continuing in parallel to develop the second edition of IEC 62304.
From here:
https://webstore.iec.ch/publication/22794

Select "Preview" for a look at the first 20 or so pages of the 'redline' version, with changed text being highlighted in red.

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yodon

Staff member
Super Moderator
#4
Thanks for the info. Would you know if a more detailed summary is availabel somewhere?
Sure! You can purchase the amendment. :)

What I see, they added the requirements for pretty much all of 5.7 (software system testing), 5.8 (software release0, and 6.2.4 (analyze change requests) for class A. Lots of other tweaks but those are, I believe, the substantive ones.
 
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