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ISO TR 24971:2020

Medical devices - Guidance on the application of ISO 14971

Standard Details

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.

General Information

Status : ACTIVE
Standard Type: Main
Document No: ISO TR 24971:2020
Document Year: 2020
Pages: 87
Edition: 2.0
  • Section Volume:
  • TC 62.SC 62A Common aspects of electrical equipment used in medical practice

Life Cycle

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ISO TR 24971:2020
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