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prSRPS CEN ISO/TR 24971:2018

Medicinska sredstva - Smernice za primenu ISO 14971

Medical devices - Guidance on the application of ISO 14971 (ISO/TR 24971:2020)

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10.99     14. 11. 2018.



Tehnički izveštaj




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].

Životni ciklus


prSRPS CEN ISO/TR 24971:2018
10.99 Novi projekat se prihvata
14. 11. 2018.

Povezani projekti

Identičan sa CEN ISO/TR 24971:2020

Identičan sa ISO/TR 24971:2020