Track 1 Session 5
9:10 to 10:10 a.m. Thursday March 27, 2008

RAMSU Approach for a Biomedical Safety Critical Automated System

The automated systems described in this presentation are complex systems composed of two main sub-systems: hardware and software. The Reliability, Availability and Maintainability (RAM) analysis approaches to these subsystems are very different. Moreover the Reliability, Availability, Maintainability and Safety (RAMS) approach applied to the Safety Critical System has to comply with international standards (such as IEC, CENELEC, etc.) and has to include the optimization of the Human-Machine Action (also called Human Factors or Usability).

This presentation describes an integrated approach applied to a Biomedical Safety Critical Automated System oriented to the optimization of Reliability, Maintainability, Availability, Safety and Usability (RAMSU) during all phases of the Product Life Cycle. This approach can help the management of an organization to assess and orient all the pre- and post-production activities for patient risk reduction. Taking into account that time and cost are two important requirements of any project, it is possible to perform only a limited number of RAMSU activities; therefore it is important for an organization to decide to perform the most effective RAMSU activities.

Key Words: Safety Critical Systems, Automated Systems, Human Factor Management, RAMSU Integrated Approach, International Standards, Dependability