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ISO/IEC Guide 63:2019

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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.

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  • Standard de ISO/IEC
  • Publié:
  • Version: 3
  • Type de document: GUIDE
  • Pages
  • Editeur: ISO/IEC
  • Distributeur: ISO/IEC
  • ICS: 01.120
  • ICS: 11.040.01
  • Comité international: ISO/TMBG

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