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eLibrary > AAMI TIR34971:2023 Application of ISO 14971 to machine learning in artificial intelligence >

AAMI TIR34971:2023 Application of ISO 14971 to machine learning in artificial intelligence, 2023

AAMI TIR34971:2023; Application of ISO 14971 to machine learning in artificial intelligence—Guide
Title page
AAMI Technical Information Report
Copyright information
Contents Page
Committee representation
Foreword
BSI British Standard
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 General requirements for risk management system [Go to Page]
4.1 Risk management process
4.2 Management responsibilities
4.3 Competence of personnel
4.4 Risk management plan
4.5 Risk management file
5 Risk analysis [Go to Page]
5.1 Risk analysis process
5.2 Intended use and reasonably foreseeable misuse
5.3 Identification of characteristics related to safety [Go to Page]
5.3.1 General
5.3.2 Data management
5.3.3 Bias
5.3.4 Data storage/security/privacy
5.3.5 Overtrust
5.3.6 Adaptive systems
5.3.7 Other safety considerations
5.4 Identification of hazards and hazardous situations
5.5 Risk estimation
6 Risk evaluation
7 Risk control
8 Evaluation of overall residual risk
9 Risk management review
10 Production and post-production activities
Annex A (informative) Risk management process overview [Go to Page]
Figure A.1—A schematic representation of the risk management process
Figure A.2—Relationship between hazard, hazardous situation, and harm
Annex B (informative) Risk management examples [Go to Page]
Table B.1—Examples of ML-related hazards
Table B.2—Examples of events and circumstances
Table B.3—Examples of relationships between hazards, foreseeable sequences of events, hazardous situations, harm, and potential risk control measures
Annex C (informative) Personnel qualifications
Annex D (informative) Considerations for autonomous systems [Go to Page]
Table D.1—IMDRF SaMD Categories
Table D.2—Possible adaptation of SaMD Categories to autonomous systems
Bibliography [Go to Page]

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