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

PD CEN ISO/TR 24971:2020

Medical devices. Guidance on the application of ISO 14971

Status : Current   Published : June 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 managementprocess 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].

Standard NumberPD CEN ISO/TR 24971:2020
TitleMedical devices. Guidance on the application of ISO 14971
Publication Date19 June 2020
Normative References(Required to achieve compliance to this standard)ISO 14971:2019
Informative References(Provided for Information)ISO 16142-1, IEC 60601-1, IEC 62502, ISO 22367, IEC Guide 120:2018, ISO 23640, IEC 60812, AAMI TIR 57:2016, IEC 61326-2-6, ISO 15197, ISO 14155, ISO 17511, ISO/TS 17822-1, ISO/IEC Guide 63:2019, IEC TR 62366-2, ISO 15189, IEC 61882, ISO 22442 (series), ISO 20776 (series), IEC TR 60601-4-1, IEC 61025, ISO 20916, IEC 80001-1:2010, IEC 62304:2006, ISO 10993-1:2018, IEC 62366-1:2015/COR1:2016, ISO 13485:2016, IEC 61010-2-101:2015, ISO 17593, IEC 60601-2-16, IEC 60601-1-2, ISO/TR 20416, IEC 60601-1-8, ISO/DIS 10017, ISO Handbook: ISO 13485:2016, ISO 11608-1, ISO 16142-2, ISO 18113 (all parts)
ReplacesPD ISO/TR 24971:2013
International RelationshipsCEN ISO/TR 24971:2020,ISO/TR 24971:2020
Amended ByCorrigendum, July 2020
DescriptorsElectrical medical equipment, Terminology, Medical equipment, Sets of data, Databases, Data representation, Data processing, Medical instruments, Information exchange, Thesauri, Data structures, Data handling, Data organization, Classification systems
Title in FrenchDispositifs médicaux. Directives relatives à l'ISO 14971
Title in GermanMedizinprodukte. Leitfaden zur Anwendung von ISO 14971
ISBN978 0 580 52399 1
File Size3.464 MB

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