Design of sterilizing equipment according to ce standards

DESIGN OF STERILIZING EQUIPMENT ACCORDING TO CE STANDARDS(M.Sc. Thesis)Bünyamin YAVUZGAZ UNIVERSITYFACULTY OF SCIENCE AND ARTSSeptember 2006ABSTRACTThe sign of CE (Conformity of Europe) in the Europe Unity is obligatoryfor industry products to release market. A product having this approvalshows the product has been produced in accordance with the NewApproach of EU Regulations and proofs that it can successfullyaccomplish its functions. This thesis reports the required preparationand procedure in the period of CE certification process, conducted bythe medical device producers (firms). Moreover, it has been dealt withwhat should be taken into considerations during the design of medicaldevices. They are also shown with a sample design (sterilizationdevice) in the context of the thesis .Science Code : 708.3.029Key Words : Medical Device, CE Declaration of Conformity,Technical File, Sterilization Device.Page Number : 100Adviser : Prof. Dr. Hüseyin Rıza BÖRKLÜ