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ISO/TR 24971 Ed.2.0 Edition 06/2020
Medical devices - Guidance on the application of ISO 14971
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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.

Status

Standard - Inactive

Origin

Technical Committee :
62A : Common aspects of electrical equipment used in medical practice

Implementation

start of the vote on the project      date of ratification (dor)   
end of the vote on the project      date of anouncement (doa)   
start of the vote on the final project      date of publication (dop)   
end of the vote on the final project      date of withdrawal (dow)   


Publication Official Journal
of the Grand-Duchy of Luxembourg
Reference

Relations

Relations to older standards
ISO/TR 24971 Ed.1.0
ISO/TR 24971 Ed.1.0

International Classification for Standards (ICS codes) :

11.040.01 : Medical equipment in general

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