CEN ISO/TR 24971:2020


Status:
Gældende
Type:
Standard
Sprog:
Kategori:

Beskrivelse

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].

Antal sider: 0

Internationale relationer :

Varenummer: M329420


Udvalg og komiteer

Komite

  • CENCLC/JTC 3

Dansk udvalg

DS/S-257