PD ISO/TR 24971:2020 + Ex Comm Kit

PD CEN ISO/TR 24971:2020 + Ex Comm Kit

Medical devices. Guidance on the application of ISO 14971

Status : Current   Published : June 2020

Format
PDF




This kit includes the below titles at a special discounted price.

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

PD ISO/TR 24971:2020 Expert Commentary Expert Commentary for PD ISO/TR 24971:2020. Medical devices. Guidance on the application of ISO 14971

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 CEN ISO/TR 24971:2020 + Ex Comm Kit
TitleMedical devices. Guidance on the application of ISO 14971
Titles in this kitPD CEN ISO/TR 24971:2020 Medical devices. Guidance on the application of ISO 14971

PD CEN ISO/TR 24971:2020 Ex Comm Expert Commentary for PD CEN ISO/TR 24971:2020. Medical devices. Guidance on the application of ISO 14971

StatusCurrent
Publication Date19 June 2020
Normative References(Required to achieve compliance to this standard)No other standards are normatively referenced
Informative References(Provided for Information)No other standards are informatively referenced
DescriptorsElectrical medical equipment, Thesauri, Data processing, Data organization, Sets of data, Information exchange, Data handling, Data structures, Medical instruments, Terminology, Data representation, Medical equipment, Databases, Classification systems
ICS11.040.01
CommitteeCH/210/4
ISBN978 0 539 14322 5
PublisherBSI
FormatA4
DeliveryYes
File Size0 KB
Price£296.80


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