Safety Requirements Elicitation Method for Medical Devices Using FRAM

Abstract

Background: As medical devices attached to human body shall be safe, it is important to elicit safety requirements for medical devices.So far, the risk driven approaches are used to derive safety requirements specification. We are trying to elicit safety requirements by the success conditions of medical device functions and operations which are clarified by describing the Functional Resonance Analysis Method (FRAM) diagram.Method: Firstly, interactions of medical device functions and its human operations are described by FRAM diagram. Secondly, the success conditions of functions are identified. Finally, safety requirements of the medical device are elicited for the identified conditions. Results:The approach is applied to elicit safety requirements of an insulin pump system. The safety requirements have been elicited by describing the FRAM diagram for the insulin pump system. The result showed the applicability of the method to elicit safety requirements. Conclusion:The proposed approach is effective to elicit safety requirements for medical devices from the success conditions of functions identified by using FRAM.