Standard

SN-CEN ISO/TR 24971:2020

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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].

Dokumentinformasjon

  • Standard fra SN
  • Publisert:
  • Utgave: 2020-07
  • Versjon: 1
  • Varetype: TR
  • ICS 11.040.01
  • National Committee SN/K 113

Produktrelasjon

  • Adoptert fra: CEN ISO/TR 24971:2020 , 0
  • Felles standardiseringsprosjekt: NEK CEN ISO/TR 24971:2020