BSI BS/AAMI 34971:2023
$142.49
Application of ISO 14971 to machine learning in artificial intelligence. Guide
| Published By | Publication Date | Number of Pages |
| BSI | 2023 | 32 |
PDF Catalog
| PDF Pages | PDF Title |
|---|---|
| 2 | Publishing and copyright information |
| 3 | Contents |
| 4 | Foreword |
| 6 | AAMI Foreword |
| 7 | Introduction |
| 8 | 1 Scope 2 Normative references |
| 9 | 3 Terms and definitions |
| 10 | 4 General requirements for risk management system 4.1 Risk management process 4.2 Management responsibilities 4.3 Competence of personnel 4.4 Risk management plan |
| 11 | 4.5 Risk management file 5 Risk analysis 5.1 Risk analysis process 5.2 Intended use and reasonably foreseeable misuse |
| 12 | 5.3 Identification of characteristics related to safety 5.3.1 General 5.3.2 Data management |
| 13 | 5.3.3 Bias |
| 15 | 5.3.4 Data storage/security/privacy |
| 16 | 5.3.5 Overtrust |
| 17 | 5.3.6 Adaptive systems |
| 18 | 5.3.7 Other safety considerations 5.4 Identification of hazards and hazardous situations |
| 19 | 5.5 Risk estimation 6 Risk evaluation |
| 20 | 7 Risk control 8 Evaluation of overall residual risk |
| 21 | 9 Risk management review 10 Production and post-production activities |
| 22 | Annex A (informative) Risk management process overview |
| 23 | Annex B (informative) Risk management examples |
| 26 | Annex C (informative) Personnel qualifications |
| 27 | Annex D (informative) Considerations for autonomous systems |
| 29 | Bibliography |
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