FD CEN ISO/TR 24971

FD CEN ISO/TR 24971

September 2020
Published document Current

Medical devices - Guidance on the application of ISO 14971

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].

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Main informations

Collections

National standards and national normative documents

Thematics

QSE, Qualité - audit - lean

Publication date

September 2020

Number of pages

97 p.

Reference

FD CEN ISO/TR 24971

ICS Codes

03.100.70   Management systems
03.120   Quality
11.040.01   Medical equipment in general

Classification index

S99-124

Print number

1

International kinship

ISO/TR 24971:2020

European kinship

CEN ISO/TR 24971:2020
Sumary
Medical devices - Guidance on the application of ISO 14971

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].

Table of contents
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  • 1 Domaine d'application
  • 2 Références normatives
  • 3 Termes et définitions
  • 4 Exigences générales relatives au système de gestion des risques
  • 5 Analyse des risques
  • 6 Évaluation des risques
  • 7 Maîtrise des risques
  • 8 Évaluation du risque résiduel global
  • 9 Revue de la gestion des risques
  • 10 Activités de production et de postproduction
  • Annexe A Identification des dangers et des caractéristiques relatives à la sécurité
  • Annexe B Techniques visant à étayer une analyse des risques
  • Annexe C Relation entre la politique, les critères d'acceptabilité du risque, la maîtrise des risques et l'évaluation des risques
  • Annexe D Informations relatives à la sécurité et au risque résiduel
  • Annexe E Rôle des normes internationales dans la gestion des risques
  • Annexe F Recommandations concernant les risques relatifs à la sûreté
  • Annexe G Composants et dispositifs conçus sans recourir à l'ISO
    14971
  • Annexe H Recommandations pour les dispositifs médicaux de diagnostic in vitro
  • Bibliographie
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