ISO/IEC Guide 63:2012Withdrawn

Guide to the development and inclusion of safety aspects in International Standards for medical devices

Guide pour l'élaboration des aspects de sécurité et leur incorporation dans des Normes internationales relatives aux dispositifs médicaux

This edition has been replaced by ISO/IEC Guide 63:2019.

Abstract / scope

ISO/IEC Guide 63:2012 provides guidance to standards 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/IEC Guide 51 to include safety-related performance and usability.

ISO/IEC Guide 63:2012 is intended to be read in conjunction with ISO/IEC Guide 51 and ISO 14971.

Life cycle

Replaces

ISO/IEC Guide 63:1999WithdrawnGuide to the development and inclusion of safety aspects in International Standards for medical devicesGuide · Published 4 Feb 1999 · ISO/TMBG

Replaced by

ISO/IEC Guide 63:2019PublishedGuide to the development and inclusion of aspects of safety in International Standards for medical devicesGuide · Published 12 Aug 2019 · ISO/TMBG