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.
Number of pages: 32
Date of approval: 2012-02-17
Date of withdrawal: 2019-08-23
International relationships: ISO/IEC Guide 63:2012 IDT