ISO/IEC GUIDE 63
Guide to the development and inclusion of aspects of safety in International Standards for medical devices
|Publication Date:||1 August 2019|
|ICS Code (Standardization. General rules):||01.120|
|ICS Code (Medical equipment in general):||11.040.01|
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.