ESR14: Towards standardized EMC assurance case patterns for the certification of medical equipment
In the end, both the EMC and Medical Directives require the manufacturer to clearly document all steps taken and decisions made to guarantee and check the conformity of the product in the so-called Technical Documentation. The purpose of the Technical Documentation is to make it possible for an external independent, external assessor or for the final user to (i) reproduce the whole reasoning followed by the manufacturer, (ii) assess the conformity of the product as well as (iii) get an overview of all (design) measures that were needed to get to that conformance or any assumptions that there might concerning the use or installation of the product. Unfortunately, there is no standardized way to write down the Technical Documentation. As a result, Technical Documentation can look very different, making it quite difficult to interpret and follow them. Looking outside of the field of EMC, standardized notations to structure and present arguments are available. More specifically, different types of graphical notations have been developed for safety assurance cases for safety critical systems, such as the Goal Structuring Notation (GSN), the Claims-Arguments-Evidence (CAE) notation and very recently the Structured Assurance Case Metamodel (SACM) language. In this task, the use of these graphical notations for documenting the overall EMC assessment of medical equipment is explored in depth, leading to a set of EMC assurance case patterns or templates.