New International Standard for Usability of Medical Devices

ISO recently released a new standard for the usability of medical devices.  The standard "Specifies a process for a manufacturer to analyse, specify, design,
verify and validate usability, as it relates to safety of a medical
device."

For all of you device manufacturing folks out there, have you had a chance to take a look at this?  If so, how do you see this impacting your UCD process at your organization?