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CEN ISO/TR 24971:2020 Edition 07/2020
Medical devices - Guidance on the application of ISO 14971 (ISO/TR 24971:2020)
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Abstract

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].

Status

Standard - Inactive

Origin

Technical Committee :
CEN/CLC/JTC 3 : Quality management and corresponding general aspects for medical devices

Implementation

start of the vote on the project      date of ratification (dor)    16/07/2020
end of the vote on the project      date of anouncement (doa)   
start of the vote on the final project    26/03/2020   date of publication (dop)   
end of the vote on the final project    15/06/2020   date of withdrawal (dow)   


Publication Official Journal
of the Grand-Duchy of Luxembourg
Reference

Relations

Relations to international standards
ISO/TR 24971:2020 
ISO/DTR 24971 

International Classification for Standards (ICS codes) :

11.040.01 : Medical equipment in general

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