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AAMI TIR24971

Medical devices— Guidance on the application of ISO 14971

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Organization: AAMI
Publication Date: 1 January 2020
Status: active
Page Count: 99
scope:

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].

[24] ISO 13485:2016, Medical devices - Quality management systems - Requirements for regulatory purposes

[25] ISO Handbook: ISO 13485:2016, Medical devices - A practical guide

Document History

AAMI TIR24971
January 1, 2020
Medical devices— Guidance on the application of ISO 14971
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...
TIR24971
January 1, 2013
Medical devices - Guidance on the application of ISO 14971
This Technical Report provides guidance in addressing specific areas of ISO 14971 when implementing risk management. This guidance is intended to assist manufacturers and other users of the standard...
TIR24971
January 1, 2013
Medical devices - Guidance on the application of ISO 14971
This Technical Report provides guidance in addressing specific areas of ISO 14971 when implementing risk management. This guidance is intended to assist manufacturers and other users of the standard...

References

This document references:
AAMI TIR57 - Technical Information Report: Principles for medical device security—Risk management
Published by AAMI on January 1, 2016
This TIR provides guidance for addressing information security within the risk management framework defined by ANSI/AAMI/ISO 14971. This guidance is intended to assist manufacturers and other users...
This document references:
AAMI TIR57 - Technical Information Report: Principles for medical device security—Risk management
Published by AAMI on January 1, 2016
This TIR provides guidance for addressing information security within the risk management framework defined by ANSI/AAMI/ISO 14971. This guidance is intended to assist manufacturers and other users...
This document references:
DS/CEN ISO/TR 20416 - Medical devices – Post-market surveillance for manufacturers (ISO/TR 20416:2020)
Published by DS on February 19, 2021
This document provides guidance on the post-market surveillance process and is intended for use by medical device manufacturers. This post-market surveillance process is consistent with relevant...
This document references:
IEC 60601-1 - MEDICAL ELECTRICAL EQUIPMENT – Part 1: General requirements for basic safety and essential performance
Published by IEC on March 1, 2021
A description is not available for this item.
This document references:
IEC 60601-1-2 - Medical electrical equipment – Part 1-2: General requirements for basic safety and essential performance – Collateral Standard: Electromagnetic disturbances – Requirements and tests
Published by IEC on September 1, 2020
This International Standard applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of MEDICAL ELECTRICAL EQUIPMENT and MEDICAL ELECTRICAL SYSTEMS, hereafter referred to as ME EQUIPMENT and ME SYSTEMS....
This document references:
IEC 60601-1-8 - Medical electrical equipment – Part 1-8: General requirements for basic safety and essential performance – Collateral standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems
Published by IEC on July 1, 2020
This International Standard applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of MEDICAL ELECTRICAL EQUIPMENT and MEDICAL ELECTRICAL SYSTEMS, hereafter referred to as ME EQUIPMENT and ME SYSTEMS....
This document is referenced by:
AAMI TIR105 - Risk management guidance for combination products
Published by AAMI on January 1, 2020
Inclusions This TIR provides recommendations on the application of risk management principles and processes during development and marketing of combination products that include a device constituent...
This document is referenced by:
AAMI TIR97 - Principles for medical device security - Postmarket risk management for device manufacturers
Published by AAMI on January 1, 2019
This TIR provides guidance for addressing postmarket security risk management within the risk management framework defined by ANSI/AAMI/ISO 14971. While it is based on the ANSI/AAMI/ISO 14971...
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