standard by International Organization for Standardization/International Electrotechnical Commission, 08/01/2019
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.
