ISO/IEC Guide 63:2019

Guide to the development and inclusion of aspects of safety in International Standards for medical devices ISO/IEC Guide 63:2019

Publication date:   Aug 12, 2019

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.