CEN ISO/TR 24971:2020

CEN ISO/TR 24971:2020
Medical devices - Guidance on the application of ISO 14971 (ISO/TR 24971:2020)
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ISO/IEC 5338:2023 Information technology - Artificial intelligence - AI system life cycle processes
Publication date: 20.12.2023
ISO/IEC JTC 1/SC 42 - Artificial Intelligence
This document defines a set of processes and associated concepts for describing the life cycle of AI systems based on machine learning and heuristic systems. It is based on ISO/IEC/IEEE 15288 and ISO/IEC/IEEE 12207 with modifications and additions of AI-specific processes from ISO/IEC 22989 and ISO/IEC 23053.
This document provides processes that support the definition, control, management, execution and improvement of the AI system in its life cycle stages. These processes can also be used within an organization or a project when developing or acquiring AI systems. When an element of an AI system is traditional software or a traditional system, the software life cycle processes in ISO/IEC/IEEE 12207 and the system life cycle processes in ISO/IEC/IEEE 15288 can be used to implement that element.
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Medical devices - Guidance on the application of ISO 14971 (ISO/TR 24971:2020)
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This document provides guidance on the development, implementation and maintenan...

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