ISO/IEC GUIDE 63:2019

This document provides requirements and recommendations to writers of medical device standards on the inclusion of aspects related to safety in International Standards, based on well-established risk management concepts and methodology.
This document is applicable to any aspect related to the safety of people, property, the environment, or a combination of these.
In this document, the term 'product' includes a medical device or a system consisting of one or more medical devices, possibly combined with non-medical devices.