DNS/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, IDT)


Status: Public comments
Start date: 20240718
End date: 20240916

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. 


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