AAMI TIR34971 2023
$122.42
AAMI TIR34971:2023 Application of ISO 14971 to machine learning in artificial intelligence
| Published By | Publication Date | Number of Pages |
| AAMI | 2023 | 33 |
This document provides guidance and intends to serve as a companion to ANSI/AAMI/ISO 14971:2019 for those performing risk management for machine learning (ML) or artificial intelligence (AI) incorporating medical devices.
PDF Catalog
| PDF Pages | PDF Title |
|---|---|
| 1 | AAMI TIR34971:2023; Application of ISO 14971 to machine learning in artificial intelligence—Guide |
| 3 | Title page |
| 4 | AAMI Technical Information Report Copyright information |
| 5 | Contents Page |
| 6 | Committee representation |
| 7 | Foreword |
| 8 | BSI British Standard |
| 9 | Introduction |
| 11 | 1 Scope 2 Normative references 3 Terms and definitions |
| 12 | 4 General requirements for risk management system 4.1 Risk management process |
| 13 | 4.2 Management responsibilities 4.3 Competence of personnel 4.4 Risk management plan |
| 14 | 4.5 Risk management file 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 General 5.3.2 Data management |
| 16 | 5.3.3 Bias |
| 18 | 5.3.4 Data storage/security/privacy |
| 19 | 5.3.5 Overtrust 5.3.6 Adaptive systems |
| 20 | 5.3.7 Other safety considerations |
| 21 | 5.4 Identification of hazards and hazardous situations 5.5 Risk estimation |
| 22 | 6 Risk evaluation 7 Risk control |
| 23 | 8 Evaluation of overall residual risk 9 Risk management review 10 Production and post-production activities |
| 24 | Annex A (informative) Risk management process overview Figure A.1—A schematic representation of the risk management process |
| 25 | Figure A.2—Relationship between hazard, hazardous situation, and harm |
| 26 | Annex B (informative) Risk management examples Table B.1—Examples of ML-related hazards |
| 27 | Table B.2—Examples of events and circumstances |
| 28 | Table B.3—Examples of relationships between hazards, foreseeable sequences of events, hazardous situations, harm, and potential risk control measures |
| 29 | Annex C (informative) Personnel qualifications |
| 30 | Annex D (informative) Considerations for autonomous systems Table D.1—IMDRF SaMD Categories |
| 31 | Table D.2—Possible adaptation of SaMD Categories to autonomous systems |
| 32 | Bibliography |
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