The ones about ergonomicsįDA recognized recently the ANSI/AAMI HE75 on Human factors engineering in the Design of medical devices. I don't have the schedule, but I don't think I will be published before 2013. The draft of part 1 - General Requirements, was approved. More, a new standard on standalone software medical devices: IEC 82304, Health Software Systems, is on the tracks. IEC 62304:2006 is currently being revised by IEC working groups. We do exactly the same with software! The ones about software Of course, this is their job to sell new versions. New ISO standards: ISO 13485:2012 and ISO 14971:2012 are expected to be published before the end of 2012. ISO members think that these standards are perfectible.
