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
2019-08
International Standard
Read sample
ISO/IEC Guide 63:2019
67944
Published (Edition 3, 2019)

ISO/IEC Guide 63:2019

ISO/IEC Guide 63:2019
67944
Language
Format
CHF 129
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The electronic version of this Guide can be downloaded from the ISO/IEC Guides web page.

Abstract

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 published [60.60]
  •  : 3
     : 26
  • ISO/TMBG
    01.120  11.040.01 
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