PD ISO/IEC GUIDE 63:2019 - Page 2

Guide to the development and inclusion of aspects of safety in International Standards for medical devices. | Status: Confirmed, Current

1 Scope 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.