# EU AI Act High-Risk Documentation — Standards References

## Primary Legislation

### EU AI Act (Regulation 2024/1689)
- **Entered into force**: 1 August 2024
- **High-risk obligations applicable**: 2 August 2026
- **Article 6 + Annex III**: High-risk classification criteria
- **Article 9**: Risk management system requirements
- **Article 10**: Data and data governance
- **Article 11 + Annex IV**: Technical documentation requirements
- **Article 13**: Transparency and provision of information to deployers
- **Article 14**: Human oversight requirements
- **Article 15**: Accuracy, robustness, and cybersecurity
- **Article 17**: Quality management system
- **Article 43**: Conformity assessment procedures
- **Article 47**: EU Declaration of Conformity
- **Article 48**: CE marking
- **Article 49**: Registration in EU database
- **Article 72**: Post-market monitoring
- **Article 73**: Serious incident reporting (15-day deadline)

## Supplementary Standards

### ISO/IEC 42001:2023 — AI Management System
- **Relevance**: Provides management system framework aligned with AI Act quality management requirements (Art. 17)

### ISO/IEC 23894:2023 — AI Risk Management
- **Relevance**: Risk management methodology compatible with Art. 9 requirements

### NIST AI RMF 1.0 (January 2023)
- **Relevance**: AI risk management framework complementary to EU AI Act risk approach

## Regulatory Guidance

### EDPB-EDPS Joint Opinion 5/2021 on the AI Act Proposal
- **Relevance**: Data protection perspective on AI regulation, GDPR-AI Act interplay

### European Commission AI Act Guidelines (forthcoming 2025-2026)
- **Relevance**: Implementing guidance for high-risk classification and conformity assessment

## Complementary Regulations

### GDPR (Regulation 2016/679)
- Article 22: Automated individual decision-making
- Article 35: DPIA requirements for AI systems
- Article 25: Data protection by design and by default