Standard

ISO/IEC Guide 63:2019

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Note: This standard has a new edition: ISO/IEC Guide 63:2019

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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.

Document information

  • Standard from ISO
  • Published:
  • Expires:
  • Edition: 3
  • Version: 1
  • Document type: GUIDE
  • ICS 01.120
  • ICS 11.040.01
  • ISO TC ISO/TMBG

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