Approved Work Item
ISO/AWI TS 24971-1
Medical devices — Guidance on the application of ISO 14971 — Part 1: Part 1: General
Reference number
ISO/AWI TS 24971-1
Edition 1
© ISO 2026
Approved Work Item
Under development
A working group has prepared a draft.
Will replace ISO/TR 24971:2020

Abstract

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, 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.

General information

  • Status
     : Under development
    Stage
    : New project registered in TC/SC work programme [20.00]
  • Edition
     : 1
  • Technical Committee :
    ISO/TC 210
  • RSS updates

Life cycle

Sustainable Development Goals

This standard contributes to the following Sustainable Development Goal

3
Good Health and Well-being

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