Richting gestandaardiseerde EMC assurance case patronen voor de certificering van medische apparatuur

This research investigates how electromagnetic disturbances (EMDs) compromise the safety and effectiveness of increasingly complex medical devices, highlighting limitations in current rule-based EMC practices and unstructured technical documentation. It identifies two central research problems: the inadequacy of prescriptive rule-based testing in addressing both foreseeable and unforeseen electromagnetic risks, and the absence of transparent, traceable EMC documentation capable of supporting high-quality safety justifications. To address these gaps, the research establishes a lifecycle-oriented approach that integrates risk management (ISO 14971), resilience engineering (IEC TS 60601-4-6), and regulatory compliance (EU MDR 2017/745). The work delivers three key contributions: a unified Risk-Resilience-Compliance framework, reusable EMC assurance case patterns, and a fully structured EMC assurance case validated through industrial case studies. These outcomes demonstrate enhanced transparency, traceability, and robustness in managing electromagnetic safety across both medical and non-medical technologies.