The new standard: IEC 62304 Medical Device Software – Software Lifecycle Processes was officially released. It is available for purchase from the IEC (copy this link http://webstore.iec.ch/webstore/webstore.nsf/searchview/?searchView=&SearchOrder=4&SearchWV=TRUE&SearchMax=1000&Submit=OK&Query=(%5BHead_Number%5D=%221%22)%20AND%20(%5BDocument_Name%5D%20CONTAINS%20%2262304%22)
to your browser to get to the order page for this standard or use the live link provided to get to the IEC webstore search page. )

This standard was based on the FDA recognized US national standard AAMI SW68 as a starting point and it is expected that this new expanded standard will be submitted for recognition by FDA.