• There are no items in your cart

ISO/TR 24971:2020

Current
Current

The latest, up-to-date edition.

Medical devices Guidance on the application of ISO 14971
Available format(s)

Hardcopy , PDF , PDF 3 Users , PDF 5 Users , PDF 9 Users

Language(s)

English, French

Published date

06-16-2020

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].

DocumentType
Technical Report
Pages
87
ProductNote
THIS STANDARD ALSO REFERS TO :AAMI TIR 57,IEC 62366-1:2015,IEC TR 62366-2,IEC 62502,IEC 80001-1:2010,ISO/IEC Guide 63:2019,ISO/DIS 10017,ISO Handbook: ISO 13485:2016,ISO 14155,ISO 15189,ISO 15197,,ISO/TR 20416
PublisherName
International Organization for Standardization
Status
Current
Supersedes

Standards Relationship
PD ISO/TR 24971:2020 Identical
PD ISO/TR 24971 Identical
CEN ISO/TR 24971:2020 Identical
SA TR ISO 24971:2020 Identical
S.R. CEN ISO/TR 24971:2020 Identical
TR T 24971:2020 Identical
CSA ISO/TR 24971:21 Identical
IS/ISO/TR 24971 : 2020 Identical
UNI ISO/TR 24971:2021 Identical

AS ISO 22367:2021 Medical laboratories - Application of risk management to medical laboratories

View more information
US$251.00
Excluding Tax where applicable

Access your standards online with a subscription

Features

  • Simple online access to standards, technical information and regulations.

  • Critical updates of standards and customisable alerts and notifications.

  • Multi-user online standards collection: secure, flexible and cost effective.