This Guide provides guidance to standard writers on how to include safety aspects in the development of medical device safety standards intended to be used within the risk management framework established in ISO 14971. It expands on the concepts developed in ISO/IECGuide 51 to include safety-related performance and usability.
DS/ISO/IEC Guide 63:2012 history
2012DS/ISO/IEC Guide 63:2012 Guide to the development and inclusion of safety aspects in International Standards for medical devices