Reliability Analysis Of Medical Steam Sterilizer Based On FMEA And FTA

Medical steam sterilizer is an important medical equipment for sterilization of surgical instruments and excipients used in various departments of hospitals.For it is a special equipment with certain pressure and easy to explode,the safety and reliability of use will directly affect the safety of operators and surrounding environment facilities.It is also used as sterilization equipment,the accuracy and timeliness of sterilization will further affect life safety of patients.Therefore,it is very important to guarantee the reliability of medical steam sterilizer.The reliability research is analyzed from the perspective of product life and system,to improve the product quality.It has been widely used in military,aerospace,electric power and chemical industries.Medical device products according to its particularity in the diagnosis and treatment process,must make it used stably and safely in the clinical application,but now the research of medicalinstruments field still stand in primary stage,design and production of medical instruments before launched,however research on reliability is very weak.In this article,analysis the reliability of medicinal steam sterilizer by using of FMEA and FTA,and based on this,advance corresponding maintenance method,prevention measures of the failure,form preventive maintenance manuals for medicinal steam sterilizer,eventually to improve use efficiency,safety,reliability of medical steam sterilizer,reduce the incidence rate of medical steam sterilizer failure.The main work is as follows.(1)Basic concepts,basic parameters and system reliability block diagrams used in reliability theory are explained in detail.(2)The risk analysis has been carried out on the medicinal steam sterilizer system function module by using FMEA analysis method,formulate FMEA analysis table and evaluate to determine subsystems of system have a higher risk,and according to the different risk level,put forward corresponding measures for daily maintenance of medical steam sterilizer.(3)Combined with FMEA analysis and clinical use,FTA qualitative analysis have been carried out on subsystem of the medicinal steam sterilizer,by building a system failure tree,analysis to confirm components have higher failure rate,put forward specificmaintenance plan and improvement measures.(4)Combined with the improvement measures,preventive maintenance manual of the medical steam sterilizer was formed,and content and maintenance period of the three-level maintenance was clarified.