DS/ISO TR 24971:2020

Medicinsk udstyr – Vejledning i anvendelse af ISO 14971


Status:
Gældende
Type:
Standard
Sprog:
EN
Kategori:
Pris fra:
kr. 847,00

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.


Antal sider: 96

Udgivet: 2020-06-22

Godkendelsesdato: 2020-06-22

Internationale relationer : ISO TR 24971:2020 IDT

ICS: 11.040.01 - Medicinsk udstyr. Generelt

Varenummer: M333733


Udvalg og komiteer

Komite

  • IEC/TC 62/SC 62A

Dansk udvalg

DS/S-562

Indgår i