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AAMI CR34971:2022 AAMI Consensus Report: Guidance on the Application of ISO 14971 to Artificial Intelligence and Machine Learning >
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AAMI CR34971:2022 AAMI Consensus Report: Guidance on the Application of ISO 14971 to Artificial Intelligence and Machine Learning, 2022
- AAMI CR34971:2022; Guidance on the Applicationof ISO 14971 to Artificial Intelligence and Machine Learning
- Title page
- AAMI Consensus Report
- Copyright information
- Contents Page
- Committee representation
- Foreword
- Introduction
- 1 Scope
- 2 Normative references
- 3 Terms and definitions
- 4 General requirements for risk management system [Go to Page]
- 5 Risk analysis [Go to Page]
- 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
- Annex B (informative) Risk management examples
- Annex C (informative) Considerations for autonomous systems
- Annex D (informative) Personnel qualifications
- Bibliography [Go to Page]
