AIaMD Document Set
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AIaMD - Technical Reports
Standard Reference Document Title
Information technology. Artificial intelligence. Overview of
PD ISO/IEC TR 24028:2020
trustworthiness in artificial intelligence
PD ISO/IEC TR 24368:2022 Information technology. Artificial intelligence. Overview of ethical and
societal concerns
PD ISO/IEC TR 24372:2021 Information technology. Artificial intelligence (AI). Overview of
computational approaches for AI systems
PD ISO/IEC TR 24027:2021 Information technology. Artificial intelligence (AI). Bias in AI systems and
AI aided decision making
PD ISO/IEC TR 24029-1:2021 Artificial Intelligence (AI). Assessment of the robustness of neural
networks — Overview
PD ISO/IEC TR 24030:2024 Information technology. Artificial intelligence (AI). Use cases
PD ISO/IEC TR 24030:2021 Information technology. Artificial intelligence (AI). Use cases
PD ISO/IEC TR 5469:2024 Artificial intelligence. Functional safety and AI systems
PD ISO/IEC TR 20226:2025 Information technology. Artificial intelligence. Environmental
sustainability aspects of AI systems
PD ISO/IEC TR 27563:2023 Security and privacy in artificial intelligence use cases. Best practices
PD CEN/CLC ISO/IEC/TR Information technology. Artificial intelligence (AI). Bias in AI systems and
24027:2023 AI aided decision making
PD CEN/CLC ISO/IEC/TR Artificial Intelligence (AI). Assessment of the robustness of neural
24029-1:2023 networks — Overview
PD CEN/CLC/TR 18145:2025 Environmentally sustainable Artificial Intelligence
PD CEN/CLC/TR 17894:2024 Artificial Intelligence. Artificial Intelligence Conformity Assessment
PD ISO/IEC TR 17903:2024 Information technology. Artificial intelligence. Overview of machine
learning computing devices
AIaMD - Standards
Standard Reference Document Title
BS ISO/IEC Information technology. Artificial intelligence. Artificial intelligence concepts
22989:2022 and terminology
BS ISO/IEC Framework for Artificial Intelligence (AI) Systems Using Machine Learning (ML)
23053:2022
BS ISO/IEC Information technology. Governance of IT. Governance implications of the use
38507:2022 of artificial intelligence by organizations
BS ISO/IEC Information technology. Artificial intelligence. Guidance on risk management
23894:2023
BS ISO/IEC Information technology. Artificial intelligence. Process management framework
24668:2022 for big data analytics
BS ISO/IEC 5259- Artificial intelligence. Data quality for analytics and machine learning (ML) —
1:2024 Overview, terminology, and examples
BS ISO/IEC 5259- Artificial intelligence. Data quality for analytics and machine learning (ML) —
3:2024 Data quality management requirements and guidelines
BS ISO/IEC 5259- Artificial intelligence. Data quality for analytics and machine learning (ML) —
4:2024 Data quality process framework
BS ISO/IEC 5338:2023 Information technology. Artificial intelligence. AI system life cycle processes
BS ISO/IEC 5339:2024 Information technology. Artificial intelligence. Guidance for AI applications
BS ISO/IEC 5392:2024 Information technology. Artificial intelligence. Reference architecture of
knowledge engineering
BS ISO/IEC Information technology. Artificial intelligence. Management system
42001:2023
BS/AAMI 34971:2023 Application of ISO 14971 to machine learning in artificial intelligence. Guide
BS EN ISO/IEC 5259- Artificial intelligence. Data quality for analytics and machine learning (ML) —
2:2025 Data quality measures
BS 30440:2023 Validation framework for the use of artificial intelligence (AI) within healthcare.
Specification
AIaMD - Standards | Continued
Standard Reference Document Title
BS ISO/IEC 24029- Artificial intelligence (AI). Assessment of the robustness of neural networks —
2:2023 Methodology for the use of formal methods
BS ISO/IEC 8183:2023 Information technology. Artificial intelligence. Data life cycle framework
BS ISO/IEC 5259- Artificial intelligence. Data quality for analytics and machine learning (ML) —
5:2025 Data quality governance framework
BS ISO/IEC Information technology. Artificial intelligence (AI). AI system impact assessment
42005:2025
BS EN ISO 18374:2025 Dentistry. Artificial intelligence (AI) and augmented intelligence (AuI) based 2D
radiograph analysis. Data generation, data annotation and data processing
BS EN ISO/IEC Information technology. Artificial intelligence. Artificial intelligence concepts
22989:2023 and terminology
BS EN ISO/IEC Framework for Artificial Intelligence (AI) Systems Using Machine Learning (ML)
23053:2023
BS ISO/IEC Information technology. Artificial intelligence. Requirements for bodies
42006:2025 providing audit and certification of artificial intelligence management systems
BS EN ISO/IEC Information technology. Artificial intelligence. Guidance on risk management
23894:2024
BS EN ISO/IEC Information technology. Artificial intelligence. Data life cycle framework
8183:2024
BS EN ISO/IEC 5259- Artificial intelligence. Data quality for analytics and machine learning (ML) —
1:2025 Overview, terminology, and examples
BS EN ISO/IEC 5259- Artificial intelligence. Data quality for analytics and machine learning (ML) —
3:2025 Data quality management requirements and guidelines
BS EN ISO/IEC 5259- Artificial intelligence. Data quality for analytics and machine learning (ML) —
4:2025 Data quality process framework
AIaMD - Regulatory
Standard Reference Document Title
REGULATION (EU) 2024/1689 OF THE EUROPEAN PARLIAMENT AND OF THE
COUNCIL of 13 June 2024 laying down harmonised rules on artificial intelligence
2024/1689/EU and amending Regulations (EC) No 300/2008, (EU) No 167/2013, (EU) No
168/2013, (EU) 2018/858, (EU) 2018/1139 and (EU) 2019/2144 and Directives
2014/90/EU, (EU) 2016/797 and (EU) 2020/1828 (Artificial Intelligence Act
AIaMD - Guidance
Standard Reference Document Title
Marketing Submission Recommendations for a Predetermined Change Control
FDA-2022-D-2628 Plan for Artificial Intelligence-Enabled Device Software Functions. Guidance for
Industry and Food and Drug Administration Staff
Interplay between the Medical Devices Regulation (MDR) & In vitro Diagnostic
MDCG 2025-6
Medical Devices Regulation (IVDR) and the Artificial Intelligence Act (AIA)
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