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ISO/IEC Guide 63:2019

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Zusammenfassung

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.

Produktspezifikationen

  • Standard von ISO/IEC
  • Ausgabedatum:
  • Edition: 3
  • Dokumenttyp: GUIDE
  • Seiten
  • Herausgeber: ISO/IEC
  • Lieferant: ISO/IEC
  • ICS: 01.120
  • ICS: 11.040.01
  • Internationales Komitee: ISO/TMBG

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