ABSTRACT
Objective:To enhance the functional safety of medical electrical equipment and reduce the risk to patient when using the medical electrical equipment.Methods: Theory and rationale introduction of functional safety and provide application cases.Results: Introduce the definition and application scope of functional safety standards IEC 61508, the determination of safety integrity level of functional safety in the Medical Electrical equipment, and the design structure and development, meanwhile show some application examples.Conclusion: Provide suggestions for the manufactures for safety design that introduce functional safety standards IEC 61508 to the development process of Medical Electrical equipment will help enhance the safety level of Medical Electrical equipment and reduce the unacceptable risk’s probability to patient.