Normas a considerar … (SoTA)
ISO 13485 Medical devices – Quality management systems – Requirements for regulatory purposes
ISO/IEC 5259-2 Artificial intelligence – Data quality for analytics and machine learning (ML) – Part 2: Data quality measures
ISO 14971 Medical devices – Application of risk management to medical devices
AAMI/BSI 34971 Application of ISO 14971 to machine learning in artificial intelligence
IEC 62304 Medical device software – Software life cycle processes
IEC 62366-1 Medical devices – Part 1: Application of usability engineering to medical devices
ISO/IEC 4213 Information technology – Artificial intelligence – Assessment of machine learning classification performance
IEC 81001-5-1 Health software and health IT systems safety, effectiveness and security – Part 5-1: Security – Activities in the product life cycle
ISO/IEC 5259-4 Artificial intelligence – Data quality for analytics and machine learning (ML) – Part 4: Data quality process framework
ISO/IEC 25024 Systems and software quality requirements and evaluation – Measurement of data quality
ISO/IEC 42001 Artificial intelligence – Management system
ISO/IEC 8183 Artificial intelligence – Data life cycle framework
ISO/IEC 5338 Artificial intelligence – AI system life cycle processes
IEC 60601-4-1 Medical electrical equipment and medical electrical systems employing a degree of autonomy
IEC 60601-4-5 Medical electrical equipment – Part 4-5: Guidance and interpretation – Safety-related technical security specifications
