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ISO/TR 24971-ed.2.0

Medical devices - Guidance on the application of ISO 14971

NORMA vydána dne 16.6.2020

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The information about the standard:

Designation standards: ISO/TR 24971-ed.2.0
Publication date standards: 16.6.2020
The number of pages: 87
Approximate weight : 292 g (0.64 lbs)
Country: International technical standard

Annotation of standard text ISO/TR 24971-ed.2.0 :

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.