Unified EMC Assurance Case to Assure Safe and Effective Medical Devices with regard to Electromagnetic Disturbances

This paper describes using a graphical notation to document why one believes that a medical device is safe and effective despite being subjected to electromagnetic disturbances. The paper discusses how this approach overcomes the drawbacks of a text-based approach as it visually summarises the claims, arguments and pieces of evidence in a clear, explicit, and easy-to-understand manner. The paper proposes an EMC assurance case using the Goal Structuring Notation. The assurance case covers three complimentary sub-cases: the risk, confidence, and compliance case. The total EMC assurance case provides compelling evidence of how effective EMC risk management is used effectively to manage relevant risks by ensuring EM-resilent design and achieving EMC compliance. It also highlights the interconnectedness among the various subcases. Together, they justify how basic safety, essential performance, and intended use of medical devices are sufficiently guaranteed in the presence of electromagnetic disturbances.