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

Abstract

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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 

  • Status
     : Published
    Publication date
     : 2019-08
  • Edition
     : 3
    Number of pages
     : 26
  • Technical Committee
     : ISO/TMBG Technical Management Board - groups
  • ICS
     :
    01.120 Standardization. General rules
    11.040.01 Medical equipment in general

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