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Homepage>BS Standards>11 HEALTH CARE TECHNOLOGY>11.040 Medical equipment>11.040.01 Medical equipment in general>PD CEN ISO/TR 24971:2020 Medical devices. Guidance on the application of ISO 14971
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immediate downloadReleased: 2020-07-22
PD CEN ISO/TR 24971:2020 Medical devices. Guidance on the application of ISO 14971

PD CEN ISO/TR 24971:2020

Medical devices. Guidance on the application of ISO 14971

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Standard number:PD CEN ISO/TR 24971:2020
Pages:96
Released:2020-07-22
ISBN:978 0 580 52399 1
Status:Corrigendum
DESCRIPTION

PD CEN ISO/TR 24971:2020


This standard PD CEN ISO/TR 24971:2020 Medical devices. Guidance on the application of ISO 14971 is classified in these ICS categories:
  • 11.040.01 Medical equipment in general

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].


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