International Standard
ISO/IEC Guide 63:2019
Guide to the development and inclusion of aspects of safety in International Standards for medical devices
Reference number
ISO/IEC Guide 63:2019
Edition 3
International Standard
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ISO/IEC Guide 63:2019
Published (Edition 3, 2019)

ISO/IEC Guide 63:2019

ISO/IEC Guide 63:2019
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The electronic version of this Guide can be downloaded from the ISO/IEC Guides web page.


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.

General information

  •  : Published
     : 2019-08
    : International Standard under systematic review [90.20]
  •  : 3
     : 26
    01.120  11.040.01 
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