PD ISO/TR 24971:2020 - TC

PD ISO/TR 24971:2020 - TC

Medical devices. Guidance on the application of ISO 14971

Status : Withdrawn   Published : June 2020


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A tracked changes version of a Standard indicates the changes made, during the standards revision process, between the active standard and its previous version. Additions, deletions, and other formatting and/or content revisions are clearly displayed as underlined and strikethrough texts, ensuring all changes made between the two documents are quickly and easily identified. This version of the standard includes both a copy of the new standard, along with a track changes version.

BS EN ISO 14971:2019 Medical devices — Application of risk management to medical devices is a key horizontal standard for the medical device market, guiding manufacturers in the development, implementation and maintenance of a risk management process for medical devices.

This document – PD ISO/TR 24971:2020 – is a Published Document and the UK implementation of an international Technical Report that gives guidance on conforming to BS EN ISO 14971:2019.

Who is PD ISO/TR 24971:2020 for?

  • Medical device manufacturers
  • Regulators
  • Other users of BS EN ISO 14971

Why should you use PD ISO/TR 24971:2020?

It gives guidance to help manufacturers develop, implement and maintain a risk management process for all medical devices that aim to meet the requirements of BS EN ISO 14971. It covers a wide variety of medical devices including active, non-active, implantable and non-implantable medical devices, software as medical devices and in vitro diagnostic medical devices.

The clauses and sub-clauses in PD ISO/TR 24971:2020 have the same structure and numbering as the clauses and sub-clauses of BS EN ISO 14971:2019. Further division into sub-clauses is applied where considered useful. The informative annexes contain additional guidance on specific aspects of risk management.

NOTE 1: Alternative approaches to those supplied in PD ISO/TR 24971:2020 may be used if these satisfy the requirements of BS EN ISO 14971:2019.

NOTE 2: When judging the applicability of the guidance in this document, users should consider the nature of the medical device(s) to which it will apply, how these medical devices are used, and the applicable regulatory requirements.

How has PD ISO/TR 24971:2020 changed since the last update?

This is a complete technical revision.

-      Clauses in ISO/TR 24971:2013  and some informative annexes from BS EN ISO 14971:2007  have been merged, restructured, technically revised and supplemented with additional guidance

-      To make the document easier to use, it has the same structure and numbering of clauses and sub-clauses as BS EN ISO 14971:2019

-      The informative annexes contain additional guidance on specific aspects of risk management


PD ISO/TR 24971:2020 contributes to UN Sustainable Development Goal 3 on ensuring healthy lives and promoting well-being for all at all ages because it supports risk management of medical devices.



Standard NumberPD ISO/TR 24971:2020 - TC
TitleMedical devices. Guidance on the application of ISO 14971
Publication Date24 June 2020
Normative References(Required to achieve compliance to this standard)ISO 14971:2019
Informative References(Provided for Information)AAMI TIR 57:2016, TR 20416, ISO 18113 (all parts), ISO 16142-2, IEC 61025, IEC 61326-2-6, IEC 60812, ISO 15197, IEC 61882, DIS 10017, IEC Guide 120:2018, ISO 14155, ISO 11608-1, ISO 17593, TS 17822-1, IEC 62502, IEC Guide 63:2019, ISO 20916, ISO 20776 (series), IEC 60601-1, ISO 15189, ISO Handbook: ISO 13485:2016, ISO 13485:2016, ISO 10993-1:2018, IEC 61010-2-101:2015, IEC 62366-1:2015/COR1:2016, IEC 62304:2006, IEC 80001-1:2010, ISO 16142-1, IEC TR 62366-2, IEC 60601-1-2, IEC TR 60601-4-1, IEC 60601-2-16, IEC 60601-1-8, ISO 17511, ISO 22442 (series), ISO 22367, ISO 23640
DescriptorsInformation exchange, Data organization, Classification systems, Medical instruments, Thesauri, Databases, Terminology, Electrical medical equipment, Sets of data, Data handling, Medical equipment, Data processing, Data representation, Data structures
Title in FrenchDispositifs médicaux - Directives relatives à l'ISO 14971 (ISO/DTR 24971:2020)
Title in GermanMedizinprodukte - Leitfaden zur Anwendung von ISO 14971 (ISO/DTR 24971:2020)
ISBN978 0 539 14326 3
File Size5.991 MB

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