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BSI PD CEN ISO/TR 24971:2020

Medical devices. Guidance on the application of ISO 14971
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BSI PD CEN ISO/TR 24971:2020

Medical devices. Guidance on the application of ISO 14971

PUBLISH DATE 2020
PAGES 96
BSI PD CEN ISO/TR 24971:2020

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 13485:2016Medical devicesA practical guide[ 25].

SDO BSI: British Standards Institution
Document Number CISO/TR 24971
Publication Date July 22, 2020
Language en - English
Page Count 96
Revision Level
Supercedes
Committee CH/210/4
Publish Date Document Id Type View
Not Available Revision
July 22, 2020 PD CEN ISO/TR 24971:2020 Consolidated