The 11st international Convention on Rehabilitation Engineering and Assistive Technology (i-CREATe 2017)
Supachai Vorapojpisut, “Model-based Design of PEMS for Medical Devices”, The 11st international Convention on Rehabilitation Engineering and Assistive Technology (i-CREATe 2017), August 22-24, 2017
This paper addresses the software design and implementation of Programmable Electrical Medical Systems (PEMS) for medical devices according to the IEC 60601-1 standard. The standard involves many aspects of medical products’ life cycle in which Clause 14 emphasizes on risk management of safety features that depend on software or any programmable element. The software design for an infant incubator is outlined to demonstrate major issues that can arise in safety-related functions. Then model-based design based on MATLAB/Simulink has been proposed as an approach to realize safety requirements. Finally, this paper discusses the claim of safety evidence using the model as executable documents.