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

Abstract Preview

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
  • :
    ISO/TMBG
    Technical Management Board - groups
  • 01.120
    Standardization. General rules
    11.040.01
    Medical equipment in general

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