Standard

ISO TR 24971:2020 ED2

Actuel

Amendements et versions existants ou nouveaux doivent être achetés séparément.

Langue
Format

Résumé

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.

Spécifications des produits

  • Standard de IEC
  • Publié:
  • Version: 2
  • Type de document: TR
  • Pages
  • Editeur: IEC
  • Distributeur: IEC
  • ICS: 11.040.01
  • Comité international: TC 62/SC 62A

Relations produit

Cycle de vie du produit