International Standard
ISO/TR 24971:2020
Medical devices — Guidance on the application of ISO 14971
Reference number
ISO/TR 24971:2020
Edición 2
2020-06
© ISO 2024
International Standard
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Publicado (Edición 2, 2020)

ISO/TR 24971:2020

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Resumen

This document provides guidance on the development, implementation and maintenance of a risk management system for medical devices according to ISO 14971:2019.

The risk management process can be part of a quality management system, for example one that is based on ISO 13485:2016[24], but this is not required by ISO 14971:2019. Some requirements in ISO 13485:2016 (Clause 7 on product realization and 8.2.1 on feedback during monitoring and measurement) are related to risk management and can be fulfilled by applying ISO 14971:2019. See also the ISO Handbook: ISO 13485:2016 — Medical devices — A practical guide[25].

Informaciones generales

  • Estado
     : Publicado
    Fecha de publicación
     : 2020-06
    Etapa
    : Norma Internacional publicada [60.60]
  • Edición
     : 2
    Número de páginas
     : 87
  • Comité Técnico :
    ISO/TC 210
    ICS :
    11.040.01 
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