A final draft (FDIS) of “IEC 82304-1: Health software – Part 1: General requirements for product safety” has been approved. The standard will be published after final editing. This is expected around the end of the year (2016).
The primary focus of this standard is on requirements for the developers of the software product. It is intended to be used alongside IEC 62304 and to cover aspects of the software product that are not covered in IEC 62304, such as accompanying documentation and software validation. This is for Health Software in general not just medical device software.