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  • BSI
    PD CEN ISO/TR 24971:2020 - TC Tracked Changes. Medical devices. Guidance on the application of ISO 14971
    Edition: 2020
    $703.31
    / user per year

Description of PD CEN ISO/TR 24971:2020 - TC 2020

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].



Standard NumberPD CEN ISO/TR 24971:2020 - TC
TitleTracked Changes. Medical devices. Guidance on the application of ISO 14971
StatusDefinitive
Publication Date2020-08-14
CorrectsPD ISO/TR 24971:2020 - TC
DescriptorsThesauri, Information exchange, Medical instruments, Data processing, Data representation, Databases, Sets of data, Medical equipment, Terminology, Electrical medical equipment, Data structures, Data handling, Data organization, Classification systems
ICS11.040.01 Medical equipment in general
CommitteeCH/210/4
ISBN978 0 539 14677 6
PublisherBSI
Pages214

About BSI

BSI Group, also known as the British Standards Institution is the national standards body of the United Kingdom. BSI produces technical standards on a wide range of products and services and also supplies certification and standards-related services to businesses.
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