Reference number
ϲʿ/TR 24971:2020
Technical Report
ϲʿ/TR 24971:2020
Medical devices — Guidance on the application of ϲʿ 14971
Edition 2
2020-06
Technical Report
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ϲʿ/TR 24971:2020
74437
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ϲʿ/TR 24971:2020

ϲʿ/TR 24971:2020
74437
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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 ϲʿ 14971:2019.

The risk management process can be part of a quality management system, for example one that is based on ϲʿ 13485:2016[24], but this is not required by ϲʿ 14971:2019. Some requirements in ϲʿ 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 ϲʿ 14971:2019. See also the ϲʿ Handbook: ϲʿ 13485:2016 Medical devices A practical guide[25].

In bundle

ϲʿ 13485:2016 + ϲʿ 13485:2016 - Medical devices - A practical guide + ϲʿ 14971:2019 + ϲʿ/TR 24971:2019
ϲʿ 13485:2016 ϲʿ 13485:2016 59752 173 ϲʿ 13485:2016 - Medical devices - A practical guide ϲʿ 13485:2016 - Medical devices - A practical guide pub100484 96 ϲʿ 14971:2019 ϲʿ 14971:2019 72704 173 ϲʿ/TR 24971:2020 ϲʿ/TR 24971:2020 72704 216
Bundle
Medical devices - the basics

This bundle combines essential ϲʿ standards to provide a robust framework for quality management and risk management in the medical device industry.

  • ϲʿ 13485:2016
  • ϲʿ 13485:2016 A practical guide
  • ϲʿ 14971:2019
  • ϲʿ/TR 24971:2020

Informaciones generales

  •  : Publicado
     : 2020-06
    : Norma Internacional publicada [60.60]
  •  : 2
     : 87
  • ϲʿ/TC 210
    11.040.01 
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