PD IEC PAS 63621:2026 PDF

What is PD IEC PAS 63621 - Artificial intelligence enabled medical devices - Data management about? PD IEC PAS 63621 (Edition 1) provides a comprehensive, high‑level framework for managing data used to train, test, or validate artificial intelligence (AI) models within medical devices. It sets out structured requirements covering the entire data lifecycle, from planning and acquisition through to use, monitoring, storage and eventual decommissioning. The standard addresses essential considerations such as data quality, suitability, integrity, privacy, security, bias mitigation, traceability, version control, documentation and governance. It also integrates AI‑specific data processes into a medical‑device‑grade quality management system (QMS), ensuring data handling supports the safe, reliable and effective performance of AI‑enabled medical technologies.