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AAMI CR34971 2022

AAMI CR34971 2022

$118.96

AAMI CR34971:2022 AAMI Consensus Report: Guidance on the Application of ISO 14971 to Artificial Intelligence and Machine Learning

Published By Publication Date Number of Pages
AAMI 2022 35
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This document provides guidance and intends to serve as a companion to ANSI/AAMI/ISO 14971:2019 for those performing risk management for artificial intelligence (AI) or machine learning (ML) incorporating medical devices. This AAMI Consensus Report does not provide a new risk management process, nor does it expand the requirements of ISO 14971. Rather, it provides guidance to assist those who are applying ISO 14971 to regulated AI medical technologies. There are many different algorithms that can support AI, including technologies such as decision trees, genetic algorithms, and neural nets. Often, when people are discussing AI, they are specifically talking about Machine Learning systems. Since Machine Learning (ML) systems are often more complicated and more opaque than other approaches, this report focuses on ML-related risks.

PDF Catalog

PDF Pages PDF Title
1 AAMI CR34971:2022; Guidance on the Applicationof ISO 14971 to Artificial Intelligence and Machine Learning
3 Title page
4 AAMI Consensus Report
5 Copyright information
Contents Page
6 Committee representation
7 Foreword
8 Introduction
11 1 Scope
2 Normative references
3 Terms and definitions
12 4 General requirements for risk management system
4.1 Risk management process
4.2 Management responsibilities
4.3 Competence of personnel
13 4.4 Risk management plan
4.5 Risk management file
14 5 Risk analysis
5.1 Risk analysis process
5.2 Intended use and reasonably foreseeable misuse
15 5.3 Identification of characteristics related to safety
5.3.1 Data management
16 5.3.2 Bias
18 5.3.3 Data storage/security/privacy
19 5.3.4 Overtrust
20 5.3.5 Adaptive systems
21 5.3.6 Other safety considerations
22 5.4 Identification of hazards and hazardous situations
5.5 Risk estimation
23 6 Risk evaluation
7 Risk control
24 8 Evaluation of overall residual risk
9 Risk management review
10 Production and post-production activities
26 Annex A (informative) Risk management process overview
28 Annex B (informative) Risk management examples
31 Annex C (informative) Considerations for autonomous systems
33 Annex D (informative) Personnel qualifications
34 Bibliography

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AAMI CR34971 2022
$118.96